Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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AVAILABLE
EXPANDED_ACCESS
Brief Summary
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Detailed Description
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Conditions
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Interventions
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OCU400
Participants will receive a subretinal injection of OCU400 modifier gene therapy product.
Eligibility Criteria
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Inclusion Criteria
2. Confirmed clinical and CLIA certified genetic diagnosis of RP (except subjects with AD-NR2E3 mutation)
3. Presence of photoreceptors as determined by spectral-domain optical coherence tomography (SD-OCT).
Exclusion Criteria
2. Considered unsuitable for any reason that may either place the subject at increased risk during participation or interfere with the interpretation of the study outcomes by the Investigator, or the Sponsor after reviewing the subject medical history and condition.
3. Previous treatment with a gene-therapy or cell therapy product, excluding OCU400.
4. Previous treatment with any investigational drug or device within one year, excluding OCU400.
5. Any contraindications for subretinal injection.
6. Cataract surgery within 3 months. YAG capsulotomy within 1 month. Any other intraocular surgery within 6 months
18 Years
99 Years
ALL
No
Sponsors
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Ocugen
INDUSTRY
Responsible Party
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Principal Investigators
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Huma Qamar, MD, MPH, CMI
Role: STUDY_CHAIR
Ocugen
Locations
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Associated Retina Consultants
Phoenix, Arizona, United States
Advanced Research
Deerfield Beach, Florida, United States
Erie Retina Research
Erie, Pennsylvania, United States
Gundersen Health
La Crosse, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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OCU400-EAP
Identifier Type: -
Identifier Source: org_study_id
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