Status:
TERMINATED
Dose Escalation Study to Evaluate the Safety/Tolerability and Efficacy of EA-2353 in Subjects With Retinitis Pigmentosa
Lead Sponsor:
Endogena Therapeutics, Inc
Conditions:
Retinitis Pigmentosa
Retinitis Pigmentosa Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 in...
Detailed Description
This is an open-label, multiple ascending dose study to evaluate the safety, tolerability, and efficacy of EA-2353 in subjects with RP. There will be up to 4 cohorts. Each of the first three cohorts w...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
June 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 24 2024
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT05392751
Start Date
June 2 2022
End Date
April 24 2024
Last Update
October 15 2024
Active Locations (5)
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1
Endogena Site 005
Miami, Florida, United States, 33136
2
Endogena Site 003
Ann Arbor, Michigan, United States, 48109
3
Endogena Site 004
Portland, Oregon, United States, 97232
4
Endogena Site 002
Dallas, Texas, United States, 75231