Study to Assess the Safety and Efficacy of OCU400 for Retinitis Pigmentosa and Leber Congenital Amaurosis

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

January 24, 2022

Primary Completion Date

March 31, 2027

Study Completion Date

March 31, 2027

Conditions
Retinitis PigmentosaLeber Congenital Amaurosis
Interventions
DRUG

OCU400 Low Dose

subretinal injection of up to 1.66×10E10 vg/mL

DRUG

OCU400 Med Dose

subretinal injection of up to 3.33×10E10 vg/mL

DRUG

OCU400 High Dose

subretinal injection of up to 1.66×10E11 vg/mL

DRUG

OCU400 Second Eye Dosing

subretinal injection of 1.0x10E11vg/mL in 250 μl

Trial Locations (7)

19107

Ocugen Site 8 - Mid Atlantic Retina - Wills Eye Hospital, Philadelphia

30322

Ocugen Site 6 - Emory University, Atlanta

33136

Ocugen Site 3 - Bascom Palmer Eye Institute, Miami

75231

Ocugen Site 1 - Retina Foundation of the Southwest, Dallas

85020

Associated Retina Consultants, Phoenix

92093

Ocugen Site 5 - University of California, San Diego (UCSD) - Shiley Eye Institute, La Jolla

97239

Ocugen Site 2 - Casey Eye Institute - OHSU, Portland

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Ocugen

INDUSTRY

NCT05203939 - Study to Assess the Safety and Efficacy of OCU400 for Retinitis Pigmentosa and Leber Congenital Amaurosis | Biotech Hunter | Biotech Hunter