Retina Trials

Study Status: Enrolling

What is the purpose of this study?
The purpose of this study is to evaluate the efficacy and safety of Oral NAC in support of cone function in patients with Retinitis Pigmentosa.

What will I have to do if I take part in this study?
If you are eligible and want to be part of the study, you will participate for 45 months (up to 9 study visits at Emory and up to 13 phone call assessments).  The researchers will ask you to do the following: Read vision charts, have your visual fields tested, have photographs taken of the back of your eyes, take the study medicine as instructed. All of these procedures will be paid for by the study.  

Is this the right trial for me?
If you are between the age of 18 and 65 and have a diagnosis of Retinitis Pigmentosa with vision better than 20/60 and no other eye conditions you may be suitable for this study and could undergo screening to assess your suitability.

Principal Investigator: Nieraj Jain, MD
Trial Coordinator:  Judith Tribe | jtribe@emory.edu
Further information/NIH Registration: ClinicalTrials.gov  

Study Status: Active not enrolling

What is the purpose of this study?
The purpose of this project, funded by the Foundation Fighting Blindness, is to characterize the natural history of disease progression in patients with EYS mutations in order to accelerate the development of outcome measures for clinical trials.

What will I have to do if I take part in this study?
If you are eligible and want to be part of the study, you will participate for 4 years and complete yearly assessments. The researchers will ask you to do the following:

• Read vision charts
• Have your visual fields tested
• Have photographs taken of the back of your eyes
• Complete questionnaires.
• All of these procedures will be paid for by the study.  

Is this the right trial for me?
If you are over the age of 18 and have a diagnosis of retinitis pigmentosa with the EYS gene identified by genetic screening, you may be suitable for this study and could undergo screening to assess your suitability.

Principal Investigator: Nieraj Jain, MD
Trial Coordinator:  Judith Tribe | jtribe@emory.edu
Further information on this trial may be found at ClinicalTrials.gov

Study Status: Active but not enrolling

What is the purpose of this study?
The purpose of this study is to ask the question, What effects does the drug, Elmiron (pentosan polysulfate sodium) have on the retina when taken for interstitial cystitis and what are the long-term retinal changes after people stop taking the drug.

What will I have to do if I take part in this study?
If you are eligible and want to be part of the study, you will participate for 48 months (5 study visits).  The researchers will ask you to do the following: Read charts at high and low luminance levels, have your visual fields tested, have photographs taken of the back of your eyes and answer some questionnaires. All of these procedures will be paid for by the study.  

Is this the right trial for me?
If you are over the age of 18 years and have taken Elmiron (Pentosan Polysulphate Sodium) for Interstitial Cystitis, then let the study doctor assess your eyes to see if you are suitable.

For more information:

• Principal Investigator: Nieraj Jain, MD
• Trial Coordinator: Judith Tribe
• ClinicalTrials.gov

Study Status: Enrolling

What is the purpose of this study?
This study is evaluating treatments for non-infectious uveitis which cause vision loss and an inflammation inside the eye. This study compares two kinds of drugs commonly used for treatment of non-infectious intermediate, posterior, and panuveitides.  Adalimumab was approved by the FDA for treatment of uveitis in 2016. The other treatment regimen is conventional immunosuppression drugs that are approved for other conditions involving inflammation, but not for uveitis. Conventional immunosuppression has been shown to be effective for treatment of uveitis and is commonly used to treat uveitis. The main objective of the study is to see how both treatment regimens compare in controlling uveitis after corticosteroids are tapered off.

What will I have to do if I take part in this study?
If you have active non-infectious uveitis and you are 13 years and older you may be eligible to participate in the ADVISE study.  You will participate for about 12 months (10 study visits). At each visit, the researchers will perform many tasks which may include obtaining your vision, examining your eyes, performing visual field tests, photographing the back of your eyes, and answering some questionnaires. You will either receive Adalimumab injections provided by the study or receive prescriptions for the immunosuppressant drugs.  

Is this the right trial for me?
If you have active non-infectious uveitis and you are 13 years and older, you may be eligible to participate in the ADVISE study. Your study doctor will examine your eyes to see if you qualify to be in the study.

For additional information

• Principal Investigator: Ghazala O’ Keefe, MD
• Trial Coordinator: Alcides Fernandes Filho
• ClincalTrials.gov  Please search using NCT03828019

Study Status: Enrolling  

What is the purpose of this study?
The primary NHOR study objective is to develop a registry of participants with macular telangectasia or MacTel Type 2, (as confirmed by the Reading Center) who will be contacted for inclusion in future clinical trials.  The second objective is to continue to identify whether there is a genetic link associated with MacTel Type 2. 

What will I have to do if I take part in this study?
If you have been clinically diagnosed with MacTel Type 2 and have agreed to take part in this study, you will have a complete eye exam including, vision testing, dilation of your eyes to examine the back of the eye, a blood draw (one tube) for genetic sequencing, and various eye photographs, images, and scans. There will be one initial clinic visit and a brief phone update yearly that will focus on your eyes, your health, and any pertinent information regarding future MacTel studies.

Photographic images of participants with a clinical diagnosis of MacTel Type 2 will be sent to a Reading Center for confirmation of the diagnosis and for grading. Blood for genetic sequencing from participants with a clinical diagnosis of MacTel Type 2 will be sent to a study-specified laboratory for analysis. The study will pay for the eye exam and all testing associated with the visit.

Is this the right trial for me?
If you are over the age of 18 and have a confirmed clinical diagnosis of MacTel Type 2 you can be assessed. 

For more information:

• Principal Investigator: Jiong Yan, M.D.
• Trial Coordinator:  Donna Leef, MMSc, COMT | 404-778-4134
• Visit  MacTel Project Registry 

Study Status: Closed to enrollment

What is the purpose of this study?
The purpose of this study is to study the effect of serine supplementation and fenofibrate treatment on serum deoxysphingolipid levels in patients with macular telangiectasia type 2 (MacTel).

What will I have to do if I take part in this study?
The screening exam will involve a fasting blood draw to determine your eligibility to participate.  If you are deemed eligible after the screening process and agree to participate in the study, at the second visit (Baseline) you will have another fasting blood sample taken and have various eye photographs and scans performed and then you will be randomly assigned to one of the following treatment groups: serine 200 mg/kg/day, serine 400 mg/kg/day, fenofibrate 160 mg/day, both serine 200 mg/kg/day and fenofibrate 160 mg/day, both serine 400 mg/kg/day and fenofibrate 160 mg/day, or no treatment (control group). Serum deoxysphingolipid levels will be used as the primary outcome, and safety will be evaluated.  Participants will be followed for 10 weeks, with visits at Screening, Week 0, 3, 6 and 10. Every visit will require a fasting blood sample and gut microbiome samples will be collected at Baseline, Week 6 and Week 10 and analyzed to determine if there is an interaction between the gut microbiome composition and the effects of the treatments.

Is this trial right for me?
If you are over the age of 21 and enrolled in the MacTel Natural and History Observation and Registry Study and diagnosed with MacTel type 2 and willing to comply with the study protocol and follow-up visits, you may be considered for participation in this study.

For more information

• Principal Investigator: Jiong Yan, M.D.
• Trial Coordinator: Donna Leef, MMSc, COMT  404-778-4134
• ClinicalTrials.gov

Study Status: Enrolling  

What is the purpose of this study?
The purpose of this study is to evaluate the safety and tolerability of a surgical implantation of three increasing doses (dose escalation) of the experimental/investigational product, ASP7317 (a cellular therapy) in people with dry AMD. This study is a Phase I clinical trial. “Phase I” means that researchers will test ASP7317 in people for the first time to see if it is safe.

What will I have to do if I take part in this study?
If you are deemed eligible after the screening process and agree to participate in the study, there will be roughly 20 visits over approximately one (1) year. After this study is completed, you may be offered to take part in the long-term follow-up study. Some of the testing which will be performed will include lab tests requiring blood draws, ECG, physical exam, complete eye exams including dilation of your eyes to examine the back of the eye, multiple kinds of vision testing, visual fields, and various eye photographs and scans. If after the evaluation to determine if you qualify for the study and you are deemed eligible, you will receive a surgical implantation of the study treatment. All these procedures including the surgery will be paid for by the study sponsor.

Is this the right trial for me?
The inclusion/exclusion guidelines for this trial include multiple criteria. To fully evaluate your match, we recommend you visit ClinicalTrials.gov and scroll down to the Criteria to Participate section to review those criteria. In general: If you are over the age of 50, have atrophy due to age-related macular degeneration in both eyes, have decreased vision, have already had cataract surgery, are generally healthy and are willing to go through all of the screening procedures to determine eligibility, this trial may be appropriate.

For more information: 

• Principal Investigator: Jiong Yan, MD
• Trial Coordinator: Donna Leef, MMSc, COMT 404-778-4134
• Visit ClinicalTrials.gov

Study Status: Closed to enrollment  

What is the purpose of this study?
The purpose of this study is to evaluate the safety and tolerability of a surgical subretinal administration of one of 3 doses of OCU 400  (a Gene Modifier Therapy) in patients with retinitis pigmentosa associated with NR2E3 and RHO genetic mutations and in patients with LCA due to mutation(s) in CEP 290 gene (LCA10)

What will I have to do if I take part in this study?
If you are deemed eligible after the screening process and agree to participate in the study, there will be roughly 12 visits over approximately 15 months. After this study is completed, you may be offered to take part in the long-term safety follow up study.   Some of the testing which will be performed will include lab tests requiring blood draws, physical exam, complete eye exams including dilation of your eyes to examine the back of the eye, multiple kinds of vision testing, visual fields, various eye photographs images and scans and interviews.  If after the evaluation to determine if you qualify for the study and you are deemed eligible, you will receive a surgical administration of the study treatment (the gene therapy).  All these procedures including the surgery will be paid for by the study sponsor.

Is this the right trial for me?
If you are over the age of 18, have a confirmed diagnosis of NR2E3 genetic mutation or rhodopsin mutations or CEP290 mutation, not pregnant, nursing or planning on becoming pregnant during the study, available to participate for the duration of the study (approximately 15 months) and are willing to go through all of the screening procedures to determine eligibility.

For more information: 

• Principal Investigator: Nieraj Jain, MD
• Trial Coordinator:  Donna Leef, MMSc, COMT 404-778-4134
• ClinicalTrials.gov

Study Status: Enrolling

What is the purpose of this study?
The purpose of this study is to:

1. Identify the prevalence and risk factors for pigmentary macular changes in patients with interstitial cystitis and/or exposure to pentosan polysulfate sodium (PPS)
2. Facilitate longitudinal care for patients identified with ocular complications through communication with their Emory Healthcare provider

What will I have to do if I take part in this study?
The only tests you will have for this study are the three types of retinal imaging below that are recommended to screen patients who have been exposed to pentosan polysulfate sodium: 

• color fundus photography
• macular optical coherence tomography
• fundus autofluorescence imaging

This imaging requires that your pupils be dilated. Dilation may cause your vision may be blurry for about 1 to 3 hours after the imaging has been completed. All imaging is performed at the Emory Eye Center and will require only one visit. The visit will take 1 to 2 hours. You will also be asked to complete a short questionnaire that will give us supporting information about your history regarding interstitial cystitis and/or your exposure to pentosan polysulfate sodium.

Is this the right study for me?
If you are over the age of 18 years and have a history of interstitial cystitis and /or exposure to Pentosan Polysulfate Sodium, you might be eligible for the study.

For more information: 

• Principal Investigator: Nieraj Jain M.D.
• Trial Coordinators: 
  • Afif Martini  
  • Lindy Dubois 

Study Status: Active but not enrolling

What is the purpose of this study?
The purpose of this study is to see if the investigational gene therapy, AAV5-hRKp.RPGR, is tolerated and useful for halting the deterioration of vision in people with X-linked Retinitis Pigmentosa (XLRP).

What will I have to do if I take part in this study
If you are eligible and want to be part of the study, you will participate for 15 months (as many as 8 – 11 study visits). The researchers will ask you to do the following: Read charts at high and low luminance levels, have your visual fields tested, have photographs taken of the back of your eyes and fill out some questionnaires. You will receive treatment for both eyes with the gene therapy. All of these procedures will be paid for by the study.  

Is this the right trial for me?
If you are male and over the age of 18 years and have had genetic testing and have the RPGR gene identified, then let the study doctor assess your eyes to see if you are suitable.

For additional information: 

• Principal Investigator: Nieraj Jain, MD
• Trial Coordinator: Judith Tribe
• ClinicalTrials.gov

Study Status: This trial is closed

What is the purpose of this study?
The purpose of this study is to follow patients with X-linked Retinitis Pigmentosa with the RPGR gene identified for 5 years in a Natural History Study.

What will I have to do if I take part in this study?
If you are eligible and want to be part of the study, you will participate for 5 years (8 study visits).  The researchers will ask you to do the following: Read charts at high and low luminance levels, have your visual fields tested, have photographs taken of the back of your eyes and answer some questionnaires. All of these procedures will be paid for by the study.

Is this the right trial for me?
If you are male and over the age of 5 years and have had genetic testing and have the RPGR gene identified, then let the study doctor assess your eyes to see if you are suitable.

For additional information

• Principal Investigator: Nieraj Jain, MD
  
• Trial Coordinator: Judith Tribe 
• ClinicalTrials.gov

Study Status: The study is currently active and enrolling at other locations. The Emory Eye Center will begin enrolling participants in 2024

What is the purpose of this study?
The purpose of this study is to collect information about people with retinal degeneration caused by mutations in their genes. We hope to learn about the traits of these people and study what happens to their eyes and vision over time. We plan to use this information to design studies for future treatments of people with gene-related retinal degeneration. We will enroll approximately 1,500 people at about 40 different medical locations in the United States and outside of the United States in the Registry phase of the study. Participation in this study is expected to last over four years.

What will I have to do if I take part in this study?
This study has two phases:  Registry/Screening and Natural History Study (NHS). You must enter the Registry phase of the study before you can enter the NHS phase. If you are eligible to enter the NHS phase, you will be given a NHS-phase consent form at the time the NHS becomes available for your gene. Not every gene will have the NHS phase. Tbe Registry phase includes the following:

Is this the right trial for me?
In general, to take part in the Registry phase of this study, you must:

• Have retinal degeneration
• Have one or more mutations in one of your genes that is the cause of your retinal degeneration
• Be willing and able to give consent
• Be willing to have annual study phone calls over four years
• Have eyes in which photographic imaging is possible
• Be at least 4 years old

• Have a history of treatment that could have affected the retina
• Have a history of certain eye conditions or surgeries that may affect the tests for this study

NOTE:  Your study doctor and staff will review more health-related requirements with you. If you are pregnant, you can still be in the study so long as you are at least 18 years old. Please tell your study doctor if you are pregnant.  

For additional information:

• Principal Investigator: Nieraj Jain, MD
• Trial Coordinator:  Olga Ostretsova 
• NIH Registration:   clinicaltrials.gov