Dose Escalation Study to Evaluate the Safety/Tolerability and Efficacy of EA-2353 in Subjects With Retinitis Pigmentosa

Stopped early · Phase 1/Phase 2

Conditions studied: Retinitis Pigmentosa, Retinitis Pigmentosa Syndrome

In brief

This is an open-label, multiple ascending dose study to evaluate the safety, tolerability, and efficacy of EA-2353 in subjects with RP. Unilateral intravitreal injections (IVT) will be administered into the subject's Study Eye. There will be up to 4 cohorts.

Key facts

Study ID

NCT05392751

Run by

Endogena Therapeutics, Inc

People needed

14

Starts

2022-06-02

Expected to finish

2024-04-24

Last updated by the study team

2024-10-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female, ≥ 18 years of age.
• Have a clinical and molecular diagnosis of RP.
• Understand the language of the informed consent and are willing and able to provide written informed consent prior to any study procedures.
• Are willing to comply with the protocol and follow the instructions including attendance at all scheduled study visits.
• BCVA in the worse eye between 20/50 and able to count fingers (CF)
• Have clear ocular media.
• Have pupillary dilation sufficient to allow for quality images.

You may not qualify if…

• Subjects who are pregnant or suspected to be pregnant and subjects who are lactating or intend to breastfeed. Female subjects of childbearing potential are required to have a negative urine pregnancy test at screening and prior to each injection, and must agree to use an acceptable method of contraception from the time of signing informed consent until the end of the study.
• Have any uncontrolled systemic disease or non-ocular disorder which would put the subject at risk due to study treatment or procedures, influence the results of the study, or impact the subject's ability to participate in the study (e.g., infection, uncontrolled elevated blood pressure, cardiovascular disease, and inability to maintain glycemic control).
• Presence of a significant ocular disease or disorder in the Study Eye.
• Have a history of any vitreoretinal surgery ever in the Study Eye.
• Have received any prior cell or gene therapy for RP.
• Have history or current abuse of alcohol and/or drugs.

Where it is running

• Endogena Site 005 — Miami, Florida, United States
• Endogena Site 003 — Ann Arbor, Michigan, United States
• Endogena Site 004 — Portland, Oregon, United States
• Endogena Site 002 — Dallas, Texas, United States
• Endogena Site 001 — McAllen, Texas, United States

Full record on ClinicalTrials.gov

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