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

Retinitis Pigmentosa Clinical Trial

Official title:
Open-label, Multiple Dose, Dose Escalation Study to Evaluate the Safety/Tolerability and Efficacy of EA-2353 in Subjects With Retinitis Pigmentosa

Clinical Trial 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 into the subject's Study Eye. There will be up to 4 cohorts.

Clinical Trial 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 will treat 3 subjects with 4 weekly injections of EA-2353. Unilateral intravitreal injections (IVT) will be administered into the subject's Study Eye, which is determined as the eye with worse vision based on the BCVA. Eligible subjects will be enrolled into one of the following three cohorts in an ascending sequential fashion: - Cohort 1 (low dose) - Cohort 2 (mid dose) - Cohort 3 (high dose) - Cohort 4 (maximum tolerated dose) Patient participation will last for approximately 25 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05392751
Study type Interventional
Source Endogena Therapeutics, Inc
Contact
Status Active, not recruiting
Phase Phase 1/Phase 2
Start date June 2, 2022
Completion date June 30, 2025
View Details
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