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Tests treatment safety and results for Geographic Atrophy
Official title A Study to Optimize Subretinal Surgical Delivery and to Evaluate Safety and Activity of Opregen in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration (GAlette); Adaptive Optics (AO) Retinal Imaging Substudy in Association With Study GR44251
ClinicalTrials.gov ID: NCT05626114
What this study is testing
What is OpRegen?
OpRegen is an investigational medicine, being studied as a potential treatment for geographic atrophy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study will evaluate the success and safety of subretinal surgical delivery as well as the preliminary activity of OpRegen in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). All endpoints are assessed for the study eye unless otherwise indicated.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older
You may be able to join if
- Ability to undergo a vitreoretinal surgical procedure under monitored anesthesia care
- Diagnosis of GA secondary to AMD
- Best corrected visual acuity (BCVA) score ≥ 29 letters and ≤ 60 letters in the study eye as assessed by Early Treatment Diabetic Retinopathy Study...
- Pseudophakic (study eye)
You likely can't join if
- Pregnancy or breastfeeding
- History of cognitive impairment or dementia
- Any type of systemic disease or its treatment, in the opinion of the investigator, including any medical conditions that could be expected to...
- Any current or history of ocular disease other than GA that may confound assessment of the macula
- History of retinal detachment
- History of vitrectomy, glaucoma-filtering surgery, or corneal transplant
See the full eligibility criteria
- Ability to undergo a vitreoretinal surgical procedure under monitored anesthesia care
- Diagnosis of GA secondary to AMD
- Best corrected visual acuity (BCVA) score ≥ 29 letters and ≤ 60 letters in the study eye as assessed by Early Treatment Diabetic Retinopathy Study (ETDRS)
- Pseudophakic (study eye)
- Pregnancy or breastfeeding
- History of cognitive impairment or dementia
- Any type of systemic disease or its treatment, in the opinion of the investigator, including any medical conditions that could be expected to progress, recur, or change to such an extent that it may bias the assessment...
- Any current or history of ocular disease other than GA that may confound assessment of the macula
- History of retinal detachment
- History of vitrectomy, glaucoma-filtering surgery, or corneal transplant
- Uncontrolled glaucoma or advanced glaucoma
- Any cataract surgery or intraocular surgery within 3 months prior to subretinal surgical delivery of OpRegen
- History of other ocular or intraocular conditions that contraindicate the use of an investigational drug or may affect interpretation of the study results or may render the participant at high risk for treatment...
- Any existing posterior segment device or implant Substudy: Inclusion Criteria: \- Participants must meet all of the inclusion criteria described in the parent study GR44251 and have the ability to comply with the...
- Participants who meet any exclusion criteria listed in the parent study GR44251
- Past history of seizures, or epileptic seizures due to any cause except for a single febrile seizure in childhood
The study team makes the final eligibility decision.
Where it's taking place
- Beverly Hills, California, United States
- Sacramento, California, United States
- San Francisco, California, United States
- St. Petersburg, Florida, United States
- Baltimore, Maryland, United States
- St Louis, Missouri, United States
- Reno, Nevada, United States
- Durham, North Carolina, United States
- Blue Ash, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Nashville, Tennessee, United States
- Austin, Texas, United States
- Bellaire, Texas, United States
- Lynchburg, Virginia, United States
- Spokane, Washington, United States
- Jerusalem, Israel
- Tel Aviv, Israel
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beverly Hills, California, United States; Sacramento, California, United States; San Francisco, California, United States; St. Petersburg, Florida, United States; Baltimore, Maryland, United States; St Louis, Missouri, United States and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.