Primary Photoreceptor Disease study: OpCT-001
Official title A Study to Investigate the Safety of OpCT-001 in Adults Who Have Primary Photoreceptor Disease (CLARICO)
ClinicalTrials.gov ID: NCT06789445
What this study is testing
What is OpCT-001?
OpCT-001 is an investigational cell therapy being studied as a potential treatment for primary photoreceptor disease. is designed to provide photoreceptor precursor cells derived from human induced pluripotent stem cells to the eye.
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
- The study aims to see if OpCT-001 is safe and how it might affect vision and eye structure in people with conditions like retinitis pigmentosa and Usher syndrome.
- Who it's for
- Adults who have primary photoreceptor diseases such as retinitis pigmentosa, Usher syndrome, or other inherited retinal disorders.
- What's involved
- Participants will receive injections of OpCT-001 at different doses, have eye exams, and undergo tests to measure vision and eye structure during the study.
- Time commitment
- The study lasts about 12 months, with several clinic visits for dosing, safety monitoring, and vision testing.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Confirmed genetic diagnosis of primary photoreceptor (PR) disease
- Best corrected visual acuity (BCVA) in the study eye at Screening for Phase 1: Logmarithm of the minimum angle of resolution (LogMAR) 3.9 to LogMAR...
- Retinal structure examination in the study eye demonstrating regions suitable for cell administration. Key
You likely can't join if
- Clinically relevant, active ocular inflammation or infection
- Glaucoma or other significant optic neuropathy
- Diabetic macular edema or diabetic retinopathy
- Clinically significant cystoid macular edema
- In phakic participants: Spherical equivalent refractive error of greater than 8.00 diopters myopia
- Ocular surgery ≤3 months before Screening
See the full eligibility criteria
- Confirmed genetic diagnosis of primary photoreceptor (PR) disease
- Best corrected visual acuity (BCVA) in the study eye at Screening for Phase 1: Logmarithm of the minimum angle of resolution (LogMAR) 3.9 to LogMAR 1.3.
- Retinal structure examination in the study eye demonstrating regions suitable for cell administration. Key
- Clinically relevant, active ocular inflammation or infection
- Glaucoma or other significant optic neuropathy
- Diabetic macular edema or diabetic retinopathy
- Clinically significant cystoid macular edema
- In phakic participants: Spherical equivalent refractive error of greater than 8.00 diopters myopia
- Ocular surgery ≤3 months before Screening
- Monocular vision (ie, no light perception in the fellow eye)
- Currently active malignancy, or history of malignancy within 5 years before OpCT-001 administration. Exception: Basal cell carcinoma that has been definitively treated.
- Any current and active infection (bacterial/viral/fungal) that could put the participant at risk from immunosuppression
- History of any cell therapy, gene therapy, or retinal implant at any time
- Previously received a bone marrow or solid organ transplant
The study team makes the final eligibility decision.
Where it is enrolling
- Los Angeles, California, United States
- Miami, Florida, United States
- Philadelphia, Pennsylvania, United States
- Dallas, Texas, United States
- Madison, Wisconsin, United States
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, but 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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Los Angeles, California, United States; Miami, Florida, United States; Philadelphia, Pennsylvania, United States; Dallas, Texas, United States; Madison, Wisconsin, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.