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OCU400-301

A Phase 3 Study Of OCU400 Gene Therapy for the Treatment Of Retinitis Pigmentosa

View on ClinicalTrials.gov

Quick Information

Age Group
Adult (18-64)
Older adult (65+)
Child (birth - 17)
Sex/Gender
All Genders
Accepts Health Volunteers
No
Phase
Phase 3
Offered at
Gundersen Health System
Condition(s)
  • Retinitis Pigmentosa
Protocol Number
NCT06388200

Summary

This is a Phase 3 study to Assess the Efficacy, Safety and Tolerability of OCU400 in patients with retinitis pigmentosa (RP) associated with RHO mutations and patients with any other RP associated mutation with a clinical phenotype of RP. This is a multicenter, assessor blinded and randomized study which will enroll 150 subjects.

Eligibility Criteria

Inclusion Criteria: 1. Males or females ≥ 8 years of age 2. Clinical diagnosis of RP with confirmed genetic diagnosis of autosomal dominant RHO mutation or any other mutation associated with RP. 3. BCVA ≤ 75 letters and ≥25 letters as measured by an ETDRS chart. 4. Visual field of \>5° in any meridian as measured by a III4e isopter or equivalent. 5. Able to perform a Luminance LDNA at certain light intensity at the Screening visit. 6. Presence of photoreceptors as determined by SD-OCT Exclusion Criteria: 1. Subject lacks evidence of outer nuclear layer 2. Previous treatment with a gene-therapy or cell therapy product or treatment with any investigational drug or ocular device within one year. 3. History of corticosteroid related IOP spikes or uncontrolled glaucoma. 4. Absence of large regions of sensitivity in the pericentral and peripheral retinal regions 5. Cataract surgery within 3 months. YAG capsulotomy within 1 month. Any other intraocular surgery within 6 months. 6. Active ocular/intraocular infection, any history of rhegmatogenous retinal detachment or Current retinal detachment or retinal implant. 7. Breast-feeding, pregnancy, sperm donation or inability to practice strict contraception

View on ClinicalTrials.gov

1900 South Ave.
La Crosse, WI 54601

(608) 782-7300

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