Current Retina Trials

Age-related Macular Degeneration (AMD)
Diabetes
Macular Telangiectasia Type 2 (MacTel)
Retinal Degenerations
Retinitis Pigmentosa
Retinoblastoma
Uvelitis and Ocular Immunology
Other Retina

 

Age-related Macular Degeneration (AMD)

NTMT503 A Multi-Center, Two-Stage, Open-Label Phase I and Randomized, Active Controlled, Masked Phase II Study to Evaluate the Safety and Efficacy of Intravitreal Implantation of NT-503-3 Encapsulated Cell Technology Compared with Eylea® for the Treatment of Recurrent Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD)
PI: Jiong Yan, M.D.
Coordinator: Donna Leef, MMSc, COMT
Status: starting enrollment

General Summary:
This research study is for an investigational new treatment; a treatment that has not yet been approved for marketing by regulatory authorities. This investigational treatment is called the NT-503-3 intraocular encapsulated cell technology (ECT) implant. This study will assess whether this experimental implant can be used to treat people with reoccurring wet AMD. The goal of this treatment is to ultimately avoid the need for frequent injections into the eye.

Clinical Summary:
The NT-503-3 ECT implant contains tiny capsules (smaller than a grain of rice) of living cells that continuously release a soluble VEGF receptor for an extended period. The ECT implant is surgically implanted into the eye with a minor procedure under local anesthesia.

The goal of this treatment is to ultimately avoid the need for frequent injections into the eye. The study will compare the safety and efficacy of the NT-503-3 ECT implanted in the eye to the Eylea® injection treatment every 8 weeks that is already available for wet AMD.

Inclusion Criteria:
•Male or female, age 50 years or older
•Active (recurrent or persistent) subfoveal CNV lesions secondary to AMD, as determined by the reading center,in at least 1 eye, the study eye at the screening visit.
•Must have received at least 3 intravitreal anti-VEGF injections (Avastin®, Lucentis® or Eylea®) in the study eye with at least 1 injection of Avastin® or Lucentis® or Eylea® in the previous 4 months
•Vision 20/40 to 20/320 in the study eye and at least 20/200 in the non-study eye

Exclusion Criteria:
•Vision worse than 20/320
•never received any anti-VEGF injections
•Subretinal hemorrhage: More than 50% of total lesion size in the study eye, as determined by the central reading center.
•Scar and/or, fibrosis: More than 25% of the total lesion size in the study eye; scar, fibrosis or atrophy (includingRPE) involving the center of the fovea as determined by the reading center.
•Inadequately responsive to the most recent anti-VEGF therapy

Contact: Donna Leef, MMSc, COMT (404) 778-4134 dleef@emroy.edu
Posted: 05-18-2015


A Prospective, Multicenter Post-Approval Study of VisionCare's Implantable Miniature Telescope in Patients with Bilateral Severe to Profound Central Vision Impairment Associated with End-Stage Age-Related Macular Degeneration

PI: Joung Kim, MD
Coordinator: Jayne Brown
Status: Enrolling

General Summary: The purpose of the IMT PAS 01 is to evaluate the safety of the intraocular telescope for the treatment of bilateral end-stage age-related macular degeneration following U.S. market approval

Clinical Summary: Patients will be closely followed for 5 years post implantation. Clinical parameters for both eyes: slit lamp & fundus exams, BCVA, IOP and corneal endothelial cell density measurement.

Inclusion Criteria:
- Retinal findings of geographic atrophy or disciform scar
- Evidence of significant cataract
- Achieve 5 letter improvement with an external telescope
- Agree to participate in post op visual training
- Minimum age of 65 years

Exclusion Criteria:
- Stargardt's macular dystrophy
- Corneal guttata
- Must meet endothelial cell density requirements per protocol

Contact: Jayne Brown, Clinical Research Coordinator, 404-778-4430
Date Posted: 02-02-2012;
Updated: 11-03-2014; 04-27-2016

 

Diabetes

 

DRCR: Prompt Panretinal Photocoagulation Versus Intravitreal Ranibizumab with Deferred Panretinal Photocoagulation for Proliferative Diabetic Retinopathy

PI: Jiong Yan, MD
Coordinator: Judy Brower, COMT
Status: Enrollment Closed.

General Summary: Standard treatment for Proliferative Diabetic Retinopathy (PDR) is laser. This study is to determine whether injections of a drug into the eye can treat PDR as well as laser treatment but with fewer side effects. Half of those enrolled will receive laser immediately, the other half will receive monthly injections as long as needed or until it is determined that laser is needed. Eyes that receive injections will have visits monthly as long as injections are needed. Eyes that received prompt laser will be seen every 16 weeks, unless needed to be seen more often. Follow-up will be 5 years - Years 4 and 5 are yearly visits only.

Inclusion Criteria:
- At least 18 years of age
- Type I or II diabetes mellitus
- Proliferative Diabetic Retinopathy

Exclusion Criteria:
– History of previous PRP laser
– Any condition affecting visual acutiy other than PDR
– History of eye injection (anti-VEGF) in the past 2 months.
– History of corticosteroid treatment in the past 4 months
– Major ocular surgery in past 4 months or expected in next 6 months
– History of YAG laser in past 2 months

Contact: Judy Brower, COMT, 404-778-4725
Posted/Updated: 07-24-2012; 01-18-2013



Macular Telangiectasia Type 2 (MacTel)

NTMT-03B: A Phase III Multicenter Randomized, Sham Controlled, Study to Determine the Safety and Efficacy of Renexus® in Macular Telangiectasia Type 2
PI: Jiong Yan, M.D.
Coordinator: Donna Leef, MMSc, COMT
Status: Enrollment starting February, 2018

General Summary:
MacTel is a disorder of the blood vessels which supply the macula, the central part of the retina that lines the back of the eye and picks up the light like the film in a camera. The “fovea,” in the center of the macula, has no blood vessels at all because they would interfere with central vision. MacTel refers to a curious, very poorly understood condition of the blood vessels around the fovea (juxtafoveal) which become dilated and incompetent, like varicose veins but on a much smaller scale.
While MacTel does not usually cause total blindness, it commonly causes loss of the central vision, which is required for reading and driving vision, over a period of 10-20 years. There is no current approved treatment for MacTel.
This study will assess whether an experimental implant (Renexus®) which releases Ciliary Neurotrophic Factor (CNTF) can be used to treat people with MacTel. CNTF is a small molecule that may help keep some nerve cells in your eye healthy. The implant, called Renexus®, is a small capsule of cells that is placed inside the eye to allow the release of CNTF directly to the retina, the light sensitive part of the eye. A total of 112 participants will be enrolled in this study at sites in the United States, Europe and Australia. Approximately 10-20 participants will be enrolled at Emory.

Clinical Summary:
This study will have two equal groups:
(1) Renexus® implant: the surgical implantation of the ) Renexus® implant
(2) Sham procedure: the placement of a dissolvable suture on the eye. A Sham procedure does not involve any treatment. It is like a control or placebo group
The study group assignment will be determined by chance (similar to a flip of a coin). You will not be able to choose which study group you want to be in. You will have a 50:50 chance of receiving the Renexus® implant. Both of your eyes will be tested to see if they are eligible. If both eyes are eligible, the study eye will also be determined by chance (flip of a coin) as only one eye can be randomized into the research study.
All participants will be followed for 24 months after the study procedure is performed.

Inclusion Criteria:
Some of the inclusion criteria include:
• Age 21 to 80
• Must have at least one study eye with a diagnosis of MacTel Type 2
• Vision 20/80 or better
• After study testing and measurements at the screening visit, study eligibility requirements are met and confirmed by an independent reading center

Exclusion Criteria:
Some of the exclusion criteria include:
• having received intravitreal steroid therapy for non-neovascular MacTel within the last 3 months
• have ever received intravitreal anti-vascular endothelial growth factor (VEGF) therapy for neovascular disease complicating MacTel in either eye
• have evidence of ocular disease other than MacTel that, in the judgment of the examining physician, may muddle the diagnosis, procedures or outcome of the study
• was a study participant in any other clinical trial of an intervention (drug or device) within the last 6 months
• currently pregnant or breastfeeding
• has a chronic requirement (eg ≥ 4 weeks at a time) for ocular medications
• has had a vitrectomy, penetrating keratoplasty, trabeculectomy or trabeculoplasty
• has had cataract surgery within 3 months of entering study
• on chemotherapy or immunopsupressive therapy
• is considered immunodeficient or a diagnosis of HIV
• has a history of ocular Herpes virus

Contact: Donna Leef; (404) 778-4134; dleef@emory.edu
Posted: 01-23-2018


A Natural History Observation and Registry Study of Macular Telangiectasia Type 2
PI: Jiong Yan, MD
Coordinator: Jayne Brown
Status: Enrolling.

General Summary:
The purpose of this study is to identify persons with MacTel Type 2, and their affected family members to create a Registry of persons with MacTel Type 2. This Registry will be used to study participants with MacTel Type 2 now and may be used in the future to identify persons to be in a study that may help find a way to prevent or treat this eye condition.

Clinical Summary:
The objective of this research study is to better understand macular telangiectasia Type 2 (“MacTel Type 2”), an uncommon eye disorder that results in slow vision loss beginning in middle age. The macula is the central part of the retina responsible for central or reading vision. Telangiectasis refers to dilated, leaky blood vessels.

Inclusion Criteria:
Patients diagnosed with Macular Telangiectasia and confirmed by the study Reading Center.

Exclusion Criteria:
Patients determined to not have Macular Telangiectasia by the study Reading Center.

Contact: Jayne Brown, (404) 778-4430
Date Posted: 08-31-2017


MacTel - A Phase 2 Multicenter Open Label Safety and Tolerability Clinical Trial of Ciliary Neurotropic Factor (CNTF) in Patients with Macular Telangiectasia Type 2 (MacTel) - Protocol NTMT-02
PI: Jiong Yan, M.D.
Coordinator: Donna Leef, MMSc, COMT
Status: recruitment closed, follow-up phase

General Summary:
MacTel is a disorder of the blood vessels which supply the macula, the central part of the retina that lines the back of the eye and picks up the light like the film in a camera. The “fovea,” in the center of the macula, has no blood vessels at all because they would interfere with central vision. MacTel refers to a curious, very poorly understood condition of the blood vessels around the fovea (juxtafoveal) which become dilated and incompetent, like varicose veins but on a much smaller scale.

While MacTel does not usually cause total blindness, it commonly causes loss of the central vision, which is required for reading and driving vision, over a period of 10-20 years. There is no current approved treatment for MacTel. This study will evaluate whether an experimental implant containing Ciliary Neurotrophic Factor (CNTF) can be used to treat people with MacTel. CNTF is a small molecule that may help keep some nerve cells in the eye healthy. The implant, called NT-501, is a small capsule of cells that is placed inside the eye to allow the release of CNTF directly to the retina, the light sensitive part of the eye.

Clinical Summary:
This study will have two equal groups:
(A) NT-501 implant: the surgical implantation of the NT-501 implant
(B) Sham procedure: the placement of a dissolvable suture on the eye. A Sham procedure does not involve any treatment. It is like a control or placebo group

Inclusion Criteria:
Some of the inclusion criteria include:
• Age 21 to 79
• Must have at least one study eye with a diagnosis of MacTel Type 2 with evidence of fluorescein leakage typical of MacTel or at least one of the other features including retinal opacification, crystalline deposits, right angle vessels, inner/outer lamellar cavities or hyperpigmentation not involving the center of the fovea, but no evidence of intraretinal/subretinal neovascularization
• Vision 20/50 or better
• After study testing and measurements at the screening visit, study eligibility requirements are met and confirmed by an independent reading center

Exclusion Criteria:
• Received intravitreal therapy for non-neovascular MacTel within the last 3 months (steroids) and within the last month (anti-VEGF)
• Is pregnant or breastfeeding
• Has a history of malignancy that would compromise the 24-month study survival
• Is on immunosuppressive therapy
• Is considered immunodeficient or has a known history of HIV;
• A history of ocular Herpes virus

Contact: Donna Leef, MMSc, COMT, (404) 778-4134, dleef@emory.edu
Posted: 05/13/2015


Retinital Degenerations

Rate of Progression in USH2A Related Retinal Degeneration (RUSH2A)
PI: Nieraj Jain, MD
Coordinator: Jayne Brown
Status: Closed to enrollment

General Summary:
This study is designed as a multicenter, longitudinal, prospective natural history study. Limited natural history data are available from patients with Usher syndrome type 2. This natural history study of patients with USH2A mutations will accelerate the development of outcome measures for clinical trials. Sensitive, objective outcome measures of retinal degeneration will greatly facilitate development of treatments for Usher syndrome patients. Together these approaches are expected to have an impact on understanding USH2A-related retinal degeneration, developing experimental treatment protocols, and assessing their effectiveness.

Clinical Summary:
USH2A mutations may also cause RP without congenital hearing loss (RP 39) (12, 19-23) and USH2A mutations may represent the most common cause of autosomal recessive RP in the U.S. (12). Retinal degeneration associated with mutations in the USH2A gene is characterized by slowly progressive rod, then cone, photoreceptor death, and relentless vision loss over decades.

Inclusion Criteria:
1. Willing and able to complete the informed consent process
2. Ability to return for all study visits over 48 months if in the natural history study
3. Age ≥ 8 years
4. At least 2 pathogenic or likely pathogenic mutations in USH2A gene from a clinically certified lab report
5. With or without hearing loss.

Exclusion Criteria:
1. Mutations in genes that cause autosomal dominant RP, X-linked RP, or presence of biallelic mutations in autosomal recessive RP/retinal dystrophy genes other than USH2A
2. Expected to enter experimental treatment trial at any time during this study
3. History of more than 1 year of cumulative treatment, at any time, with an agent associated with pigmentary retinopathy (including hydroxychloroquine, chloroquine, thioridazine, and deferoxamine)
Contact: Jayne Brown (404) 778-4430
Posted: 08/31/2017


A Compassionate Use of Encapsulated Human NTC-201 Cell Implants Releasing Ciliary Neurotrophic Factor for Participants with Retinal Degenerative Diseases
PI: Jiong Yan, M.D.
Coordinator: Donna Leef, MMSc, COMT
Status: In follow up.

General Summary:
This study is to collect extended data on patients who were previously implanted with a capsule which releases a substance called “CNTF” into the fluid of ther eye. CNTF is a naturally occurring substance in the body that acts to protect nerve cells. The CNTF implants were developed by Neurotech Pharmaceuticals USA, the sponsor of this trial. All of the enrolled 9 participants have had the capsule implanted for more than 24 months.

Clinical Summary:
To further evaluate participant safety and to continue collecting information on the effectiveness of the implant, we are asking those patients who were originally implanted to continue participating in this study for one additional “extension” study visit. The additional study visit will take place between Month 26 and 50 after the date of the implant.

Inclusion Criteria: Previous participant in the Compassionate Use of Encapsulated Human NTC-201 Cell Implants Releasing Ciliary Neurotrophic Factor for Participants with Retinal Degenerative Diseases between 2011 and 2012.

Exclusion Criteria:
Not a participant in the Compassionate Use of Encapsulated Human NTC-201 Cell Implants Releasing Ciliary Neurotrophic Factor for Participants with Retinal Degenerative Diseases between 2011 and 2012

Contact: Donna Leef, MMSc, COMT (404) 778-4134, dleef@emory.edu
Posted: 05/14/2015

 

Retinitis Pigmentosa

Argus II Retinal Prosthesis System Post Approval Study (Protocol PM-02-01)
PI: Jiong Yan, MD
Coordinator: Jayne Brown
Status: Closed

General Summary: The purpose of this study is to collect additional information from Argus II users in order to monitor the system's safety and collect additional data about how much it improves people's visual function and activities of daily living.

Clinical Summary: This study is a 5 year post-market approval study, to collect additional information regarding safety and performance of the ARGUS II. The ARGUS II is approved as a Humanitarian Use Device.

Inclusion Criteria:

- at least 25 years old
- severe to profound retinitis pigmentosa diagnosis
- previous history of useful form vision
- bare or no light perception in both eyes

Exclusion Criteria:
- ocular structures or conditions preventing successful working of or implantation of the device
- inability to tolerate general anesthesia, or antibiotic and steroid regimen
- pregnancy or plans to become pregnant during course of study

Contact: Jayne Brown, 404-778-4430 office phone

Posted: 01-02-14

 

Uvelitis and Ocular Immunology

LUMINA
PI: Ghazala O'Keefe, MD
Coordinator: Jayne Brown
Status: Enrolling

General Summary:
A sham controlled, randomized, double masked study for treatment of active, non-infectious, posterior segment uveitis. 5 monthly visits with 2 injections, then 6 months of open label with 2 injections

Clinical Summary:
This 12 month clinical trial uses Santen's DE-109 injection solution via intravitreal injections for posterior segment, non-infectious uveitis.

Inclusion Criteria:
1. Minimum of 18 yrs old
2. Non-infectious, posterior segment >> anterior segment active uveitis
3. Greater than or equal to 1.5 VH score in study confirmed by Reading Center
4. BCVA greater than 20 ETDRS letters (20/400 Snellen) and less than 75 ETDRS letters (20/32 Snellen)
5. If on IMT, must be a stable dose of MTX/AZA/ MMF for 30 days prior to Day 1
6. If on IMT, systemic corticosteroid dose of 15 to 40 mg/day must be stable for one week prior to and including to Day 1
7. Stable topical corticosteroid drops for 7 days prior to Day 1

Exclusion Criteria:
1. Suspected infectious uveitis in either eye
2. Ocular or periocular infection in either eye
3. Primary diagnosis of anterior Uveitis in study eye
4. The following ocular inflammatory conditions in study eye: Bechet’s Disease, Serpiginous
Choroiditis, Punctate Inner Choroidopathy (PIC), Acute Posterior Multifocal Placoid Pigment
Epitheliopathy (APMPPE)
5. Uncontrolled Glaucoma (IOP > 21mmHg) while on therapy
6. Any other active ocular disease other than uveitis that might compromise vision
7. History of vitrectomy in study eye
8. Epiretinal membrane significant enough to limit improvement of macular edema

Contact Name: Jayne Brown, (404) 778-4430
Contact Email: jmbrown@emory.edu
Posted/Last Updated: 06-28-2019

 


Macular Edema Ranibizumab v. Intravitreal Anti-inflammatory Therapy Trial (MERIT)
PI: Steven Yeh, MD
Coordinator: Alcides Fernandes Filho
Status: Recruiting

General Summary:
The Macular Edema Ranibizumab v. Intravitreal anti-inflammatory Therapy (MERIT) Trial will compare the relative efficacy and safety of intravitreal methotrexate, intravitreal ranibizumab, and the intravitreal dexamethasone implant for the treatment of uveitic macular edema persisting or reoccurring after an intravitreal corticosteroid injection. MERIT is a parallel design (1:1:1), randomized comparative trial with an anniversary close-out at the 6 month clinic visit. The primary outcome is percent change in central subfield thickness from the baseline OCT measurement to the 12 week visit.

Clinical Summary:
Macular edema (ME) is the most common structural complication and cause of visual impairment and legal blindness in uveitis patients. Traditional approaches to the treatment of uveitic ME have included the use of regional corticosteroid therapy, delivered periocularly, including posterior sub-Tenon's and orbital floor injections, or via the intravitreal route. While corticosteroid injections may reduce ME and improve vision, the effect is often variable with a limited duration.

Persistent macular edema is a common occurrence and often requires repeated intravitreal injections of corticosteroids, which expose eyes to a significant risk of increased intraocular pressure ocular and cataract development. The often refractory nature of uveitic ME and its impact on visual function underscores the need to identify effective alternative medical therapeutic options.

Recent pilot studies have shown intravitreal methotrexate (MTX) and intravitreal ranibizumab (Lucentis®, Genentech Inc., San Francisco, CA) to be promising treatments for uveitic ME, and intravitreal dexamethasone implant (Ozurdex®, Allergan, Irvine, CA) has recently been approved by the U.S. FDA for uveitic ME in patients with non-infectious uveitis. In addition to being effective, intravitreal MTX and ranibizumab potentially may have less ocular side effects than corticosteroids, particularly less IOP elevation. However, the relative efficacy of these treatments is unknown.

The Macular Edema Ranibizumab v. Intravitreal anti-inflammatory Therapy (MERIT) Trial will compare the relative efficacy and safety of intravitreal methotrexate, ranibizumab, and dexamethasone implant. MERIT is a parallel design (1:1:1), randomized comparative effectiveness trial with an anniversary close-out at the 6 month clinic visit. The primary outcome is percent change in central subfield thickness from the baseline OCT measurement to the 12 week visit.

Inclusion Criteria:
Patient level inclusion criterion
1. 18 years of age or older; Eye level inclusion criteria - at least one eye must meet all of the following conditions
2. Inactive or minimally active non-infectious anterior, intermediate, posterior or panuveitis, as defined by SUN132 criteria as ≤ 0.5+ anterior chamber cells, ≤ 0.5+ vitreous haze grade and no active retinal/choroidal lesions for a minimum of 4 weeks;
3. Macular edema (ME) defined as the presence of macular thickness greater than the normal range for the OCT machine being used (see cut points below), regardless of the presence of cysts, following an intravitreal corticosteroid injection (≥ 4 weeks following intravitreal triamcinolone injection or ≥ 12 weeks following intravitreal dexamethasone implant injection); Greater than 300 μm for Zeiss Cirrus Greater than 320 μm for Heidelberg Spectralis Greater than 300 μm for Topcon 3DOCT
4. Baseline fluorescein angiogram that, as assessed by the study ophthalmologist, is gradable for degree of leakage in the central subfield;
5. Best corrected visual acuity (BCVA) 5/200 or better;
6. Baseline intraocular pressure > 5 mm Hg and ≤ 21 mm Hg (current use of ≤3 intraocular pressure-lowering medications and/or prior glaucoma surgery are acceptable (Note: combination medications, e.g., Combigan, are counted as two IOP-lowering medications);
7. Media clarity and pupillary dilation sufficient to allow OCT testing and assessment of the fundus.

Exclusion Criteria:
Patient level exclusion criteria
1. History of infectious uveitis in either eye;
2. History of infectious scleritis of any type in either eye (Note: History of noninfectious scleritis that has been active in past 12 months is an eye-level exclusion -see #13 below);
3. History of keratitis (with the exception of keratitis due to dry eye) in either eye;
4. History of central serous retinopathy in either eye;
5. Active infectious conjunctivitis in either eye;
6. Oral prednisone dose > 10 mg per day (or of an alternative corticosteroid at a dose higher than that equipotent to prednisone 10 mg per day) OR oral prednisone dose ≤ 10 mg per day at baseline that has not been stable for at least 4 weeks (note: if patient is off of oral prednisone at baseline (M01 study visit) dose stability requirement for past 4 weeks does not apply);
7. Systemic immunosuppressive drug therapy that has not been stable for at least 4 weeks (note: use of systemic methotrexate is acceptable as long as regimen has been stable for at least 4 weeks);
8. Use of oral acetazolamide or other systemic carbonic anhydrase inhibitor at baseline;
9. Known allergy or hypersensitivity to any component of the study drugs;
10. For women of childbearing potential: pregnancy, breastfeeding, or a positive pregnancy test; unwilling to practice an adequate birth control method (abstinence, combination barrier and spermicide, or hormonal) for duration of trial; Eye level exclusion criteria - at least one eye that meets all inclusion criteria cannot have any of the following conditions
11. History of infectious endophthalmitis;
12. History of severe glaucoma as defined by optic nerve damage (cup/disc ratio of ≥ 0.9 or any notching of optic nerve to the rim);
13. History of active noninfectious scleritis in past 12 months (Note: History of noninfectious scleritis is acceptable if the last episode of active scleritis resolved at least 12 months prior to enrollment);
14. Presence of an epiretinal membrane noted clinically or by OCT that per the judgment of study ophthalmologist may be significant enough to limit improvement of ME (i.e., causing substantial wrinkling of the retinal surface);
15. Torn or ruptured posterior lens capsule
16. Presence of silicone oil;
17. Ozurdex administered in past 12 weeks;
18. Anti-VEGF agent, intravitreal methotrexate, or intravitreal/periocular corticosteroid administered in past 4 weeks;
19. Fluocinolone acetonide implant (Retisert) placed in past 3 years.

Contact: Alcides Fernandes Filho, (404) 778-2421, afilho@emory.edu
Date Posted: 01-19-2018

 


PeriOcular and INTravitreal corticosteroids for uveitic macular edema (POINT)
Trial PI: Steven Yeh, MD, Associate Professor of Ophthalmology Coordinator: Alcides Fernandes Filho, MD
Status: Closed to enrollment

General Summary: Macular edema is the most common complication and leading cause of visual loss in patients with uveitis. Approximately 40% of patients with intermediate uveitis, posterior uveitis, or panuveitis develop macular edema. Ocular injections of corticosteroids are the most frequently used treatments specifically for uveitic macular edema but there is a lack of high quality evidence to guide choice of drug (e.g., triamcinolone acetonide, dexamethasone) and route of administration (e.g. periocular, intravitreal). The question of how to approach local treatment of uveitic macular edema is a key question for ophthalmologists treating these patients.

The Periocular and Intravitreal Corticosteroids for Uveitic Macular Edema (POINT) Trial is a randomized trial designed to compare the relative efficacy of three regional corticosteroids commonly utilized for the initial regional treatment of uveitic macular edema, periocular triamcinolone, intravitreal triamcinolone, and the intravitreal dexamethasone implant.

The design outcome is the percent change in central subfield macular thickness on OCT from baseline to the 8 week visit. Follow-up through 24 weeks will allow evaluation of the duration of response and the need for additional injections. Secondary outcomes include resolution of macular edema, IOP elevation, visual acuity, complications of treatment, and cost-effectiveness.

Clinical Summary: The POINT Trial was designed to evaluate the relative efficacy of three commonly utilized regional corticosteroids for the regional treatment of uveitic macular edema: periocular triamcinolone acetonide; intravitreal triamcinolone acetonide; intravitreal dexamethasone implant.

After signing informed consent and undergoing eligibility evaluation, eligible patients will be randomized to one of the three study treatments to be administered at the first study visit. Randomization is by participant, if both eyes meet eligibility requirements then both eyes receive assigned treatment. The primary efficacy measure will be percent change in central subfield thickness as measured by OCT at 8 weeks.

After assessment of the primary outcome at 8 weeks, second injections and best medical judgment will be used if macular edema has not improved as follows:

Eye(s) meeting trial eligibility criteria receive initial injection of assigned treatment at P01 visit.

Second injection of assigned treatment permitted at 8 week visit for periocular triamcinolone and intravitreal triamcinolone and at 12 week visit for intravitreal dexamethasone if

- Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) or
- Eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield or
- ME is worse after initial improvement And the following repeat injection criteria are met:

- IOP of ≤21 or mm Hg and treatment with ≤2 IOP-lowering agents;

- Best corrected visual acuity of 20/40 or worse;

Eyes demonstrating no improvement or worsening of ME as measured by the central submacular thickness on OCT (at week 12 for periocular and intravitreal triamcinolone arms and at week 20 for intravitreal dexamethasone arm) are considered primary treatment non-responders.

Inclusion Criteria:
1. 18 years of age or older;

Eye level inclusion criteria - at least one eye must meet all of the following conditions:
2. Non-infectious anterior, intermediate, posterior or panuveitis; either active or inactive uveitis is acceptable;
3. Macular edema (ME) defined as the presence of central subfield macular thickness greater than the normal range for the OCT machine being used, regardless of the presence of cysts, as assessed by study ophthalmologist;
4. Best corrected visual acuity (BCVA) worse than 20/32 and 5/200 or better;
5. Baseline intraocular pressure > 5 mm Hg and ≤ 21 mm Hg (current use of 2 or fewer intraocular pressure-lowering medications and/or prior glaucoma surgery are acceptable);
6. Baseline fluorescein angiogram that is gradable for degree of leakage in the central subfield
7. Pupillary dilation sufficient to allow OCT testing.

Exclusion Criteria:
1. History of infectious endophthalmitis or infectious uveitis in either eye;
2. History of scleritis or keratitis of any type in either eye;
3. For women of childbearing potential: pregnancy, breastfeeding, or a positive pregnancy test; unwilling to practice an adequate birth control method (abstinence, combination barrier and spermicide, or hormonal) for duration of trial;
4. Use of oral acetazolamide or other systemic carbonic anhydrase inhibitor at baseline;
5. Oral prednisone dose > 10 mg per day (or of an alternative corticosteroid at a dose higher than that equipotent to prednisone 10 mg per day) OR oral prednisone dose ≤ 10 mg per day that has not been stable for at least 4 weeks;
6. Systemic immunosuppressive drug therapy that has not been stable for at least 4 weeks;
7. Known allergy or hypersensitivity to any component of the study drugs;

Eye level exclusion criteria - at least one eye that meets all inclusion criteria cannot have any of the following conditions:
8. History of severe glaucoma as defined by optic nerve damage (cup/disc ratio of ≥ 0.9 or any notching of optic nerve to the rim);
9. Media opacity causing inability to assess fundus or perform OCT;
10. Presence of an epiretinal membrane noted clinically or by OCT that per the judgment of study ophthalmologist may be significant enough to limit improvement of ME (i.e., causing substantial wrinkling of the retinal surface) 81;
11. Presence of silicone oil;
12. Periocular or intravitreal corticosteroid injection in past 8 weeks;
13. Injection of dexamethasone intravitreal implant in past 12 weeks;
14. Placement of fluocinolone acetonide implant (Retisert) in past 3 years;
15. Topical NSAID use if dose has not been stable for at least 4 weeks.

Contact: Alcides Fernandes Filho, (404) 778-2421, afilho@emory.edu
Date Posted: 11-3-2015


A Prospective, Multi-Center, Randomized, Double-Masked, Positive-Controlled, Phase 3 Clinical Trial Designed to Evaluate the Safety and Efficacy of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution Compared to Prednisolone Acetate Ophthalmic Suspension (1%) in Patients with Non-Infectious Anterior Segment Uveitis

PI: Steven Yeh, MD
Coordinator: Jayne Brown
Status: Closed to enrollment

General Summary: The purpose of this study is to see how well a new drug and associated drug delivery system treat patients with non-infectious anterior uveitis compared to Prednisolone Acetate (positive-control eye drops), the standard of care.The study drug, Dexamethasone Phosphate, and associated drug delivery system, ocular iontophoresis are investigational, which means they have not yet been approved by the United States Food and Drug Administration (FDA).

Clinical Summary: This is a prospective, multi-center, randomized, double-masked, Phase 3 clinical trial designed to evaluate the efficacy and safety of ocular iontophoretic delivery of dexamethasone phosphate ophthalmic sloution to prednisolone acetate ophthalmic suspension (1%) in patients with non-infectious anterior segment uveitis.

Inclusion Criteria: Adults diagnosed with non-infectious anterior segment uveitis defined as an anterior chamber cell count greater than or equal to 11 cells.

Exclusion Criteria:
- Have intermediate or posterior uveitis.
- Have used topical corticosteriod in the study eye less that 48 hours prior to Baseline Visit.
- Have used oral corticosteroid within 14 days of Baseline Visit.
- Steroid responder in either eye.

Contact: Jayne Brown, Clinical Research Coordinator, 404-778-4430
Sponsor: Eyegate Pharmaceuticals
Date Posted: 07-25-2012
Last Updated: 04-27-2016; 05-15-2018

 

Other Retina

Guard Trial: A Multicenter, Randomized, Controlled, Prospective, Adaptive Phase 3 Clinical Trial of Repeated Intravitreal Injections of ADX-2191 versus Standard of Care for the Prevention of Proliferative Vitreoretinopathy

PI: G.. Baker Hubbard, MD

Coordinator: Judith Tribe and Jayne Brown

Status: Enrollment open

General Summary: 
This Phase 3 trial will assess the effectiveness of Intravitreal Injections of ADX-2191 ( intravitreal methotrexate) compared to standard of care treatment in the prevention of Proliferative Vitreoretinopathy (PVR) following Retinal detachment surgery (PVR is a leading cause of failure of retinal detachment surgery). 

Clinical Summary: 
This will be a randomized, controlled Phase 3 trial. The trial will follow patients for 6 months after they are randomized (1:1) into the treatment or control arm (Standard of Care). The treatment arm will receive injections of intravitreal methotrexate (ADX-2191) weekly for 8 weeks then every 2 weeks for 6 weeks and all patients will be followed for 24 weeks.

Inclusion Criteria: 
Some of the inclusion criteria are:
1 Men or women who are 18 years or older
2 Must be undergoing a pars plana vitrectomy for either recurrent retinal detachment due to PVR or retinal detachment due to an open globe injury
3 At the conclusion of the surgery the retina must be completely reattached and the surgeon must judge that enrollment will benefit patient
4 Subjects are willing and able to provide written informed consent and comply with trial procedures and are able to attend all trial visits

Exclusion Criteria: 
Some of the exclusion criteria are:
1 No light perception at screening
2 History of severe non-proliferative or proliferative diabetic retinopathy
3 History of significant intraocular inflammation
4 History of severe dry eye or significant corneal disease
5 History of incisional glaucoma surgery
6 Any other planned eye surgery during the trial
7 History of more than 6 Retinal detachments
8 Hypersensitivity to methotrexate medication 
9 Received methotrexate within 3 months of screening visit

Contact Name: 
Judith Tribe, jtribe@emory.edu
Jayne Brown, jmbrown@emory.edu

Contact Phone Number: (404) 778-5629

Posted/Last Updated: 09/09/2020


SAPPHIRE: A randomized, masked, controlled trial to study the safety and efficacy of suprachoroidal CLS-TA in conjunction with Intravitreal Aflibercept in subjects with Retinal Vein Occlusion

PI: Andrew Hendrick, MD
Job Title: Clinical Research Coordinator
Coordinator: Jayne Brown
Status: Closed to enrollment

General Summary:
To demonstrate that suprachoroidal (SC) CLS-TA administered in conjunction with intravitreal (IVT) aflibercept is superior to IVT aflibercept alone in the proportion of subjects demonstrating >= 15 letter improvement in best corrected visual acuity (BCVA) two months after Baseline

Clinical Summary:
This is a Phase 3, multicenter, randomized, masked, controlled, parallel group study of 12 months duration in treatment-na´ve subjects with RVO. Randomly assignment of 1:1 to one of two treatment groups stratified by disease (BRVO, CRVO). The study design includes 12 clinic visits over approximately 50 weeks.

Inclusion Criteria:

- Has an ETDRS BCVA score of >= 5 letters read and <= 70 letters read in the study eye.
- Is na´ve to local pharmacologic treatment for RVO in the study eye.
- Has a CST of >= 300 ?m in the study eye (SD-OCT) with or without subretinal fluid.
- RVO in the study eye within <= 9 months screening.

Exclusion Criteria:

-Has, in the study eye, used any topical ocular corticosteroid in the 10 days before treatment at Visit 2 (Day 0); received any intraocular or periocular corticosteroid injection in the 2 months before treatment; had an OZURDEX« implant in the 6 months before treatment, a RETISERT« implant in the 1 year before treatment, or an ILUVIEN« implant in the 3 years before treatment.
- History of vitreo retinal surgery 3 month prior to study enrollment.
- Has evidence of or history of any ophthalmic condition in the study eye that may have an associated neovascularization or edema component.
- Has a IOP > 22 mmHg or uncontrolled glaucoma (open angle or angle closure) in the study eye at Visit 1 (Day -14 to -1); cannot have had glaucoma surgery
- can be taking no more than 2 IOP-lowering medications.

Contact Name: Andrew Hendrick, (404) 778-5065
Posted/Last Updated: 06-29-2017

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