Retinitis Pigmentosa Clinical Trial
Official title:
A Phase 3, Multi-Center, Randomized Study to Assess The Efficacy, Safety and Tolerability of Subretinal OCU400 Gene Therapy for the Treatment of Retinitis Pigmentosa
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.
A total of one hundred and fifty (150) RP participants will be enrolled in this study- 75 in each of either two arms, RHO arm (n=75) or Gene agnostic arm (n=75). RHO arm will only enroll participants with confirmed genetic diagnosis of mutation in RHO gene; whereas Gene Agnostic arm will enroll RP Participants based on clinical diagnosis of RP and a confirmed genetic diagnosis with a gene associated with RP. Subjects in each arm will be randomized into treatment (N=50) and control groups (N=25). Subjects in the treatment group will receive a sequential, bilateral sub-retinal injection of OCU400 if both eyes meet inclusion criteria. Control or untreated group subjects will receive OCU400 subretinal injection after completion of 12-month follow-up. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT01432847 -
Cell Collection to Study Eye Diseases
|
||
| Completed |
NCT04983914 -
Retrospective NIS to Evaluate the Patient Benefit of TES
|
||
| Recruiting |
NCT03845218 -
Retinitis Pigmentosa Clinical Measures and Repeatability Testing of Potential Outcome Measures
|
||
| Completed |
NCT00231010 -
Molecular Genetics of Retinal Degenerations
|
||
| Active, not recruiting |
NCT04611503 -
PDE6A Gene Therapy for Retinitis Pigmentosa
|
Phase 1/Phase 2 | |
| Completed |
NCT02909985 -
Visual Activity Evoked by Infrared in Humans After Dark Adaptation
|
N/A | |
| Recruiting |
NCT01914913 -
Clinical Study to Evaluate Safety and Efficacy of BMMNC in Retinitis Pigmentosa
|
Phase 1/Phase 2 | |
| Completed |
NCT01949623 -
Biomarkers In Retinitis Pigmentosa (BIRP)
|
N/A | |
| Completed |
NCT01835002 -
Transcorneal Electrical Stimulation - Multicenter Safety Study
|
N/A | |
| Completed |
NCT00407602 -
Argus® II Retinal Stimulation System Feasibility Protocol
|
N/A | |
| Completed |
NCT00515814 -
Retina Implant Pilot Trial to Evaluate Safety & Efficacy in Blind Patients Having Degenerated Photo-receptors
|
N/A | |
| Completed |
NCT00100230 -
DHA and X-Linked Retinitis Pigmentosa
|
Phase 2 | |
| Active, not recruiting |
NCT00378742 -
Repository for Inherited Eye Diseases
|
||
| Terminated |
NCT05085964 -
An Open-Label Extension Study to Evaluate Safety & Tolerability of QR-421a in Subjects With Retinitis Pigmentosa
|
Phase 2 | |
| Recruiting |
NCT05805007 -
Safety and Tolerability Study of Gene Editing Drug ZVS203e in Participants With Retinitis Pigmentosa
|
Early Phase 1 | |
| Recruiting |
NCT06291935 -
Safety and Tolerability of Intravitreal Administration of VG901 in Patients With Retinitis Pigmentosa Due to Mutations in the CNGA1 Gene
|
Phase 1 | |
| Recruiting |
NCT05909488 -
Role of UC-MSC and CM to Inhibit Vision Loss in Retinitis Pigmentosa Phase I/II
|
Phase 2/Phase 3 | |
| Recruiting |
NCT03078309 -
The Effects of Cannabis on Visual Functions in Healthy and Retinitis Pigmentosa Patients
|
Early Phase 1 | |
| Completed |
NCT04238858 -
Effects of Subtenon-injected Autologous Platelet-rich Plasma on Visual Functions in Eyes With Retinitis Pigmentosa
|
N/A | |
| Active, not recruiting |
NCT01680510 -
The Effect of Oral Administration of 9-cis β Carotene Rich Powder of the Alga Dunaliella Bardawil
|
Phase 1/Phase 2 |