NCT05392751

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

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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Endogena Therapeutics, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 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.

Conditions

• Retinitis Pigmentosa
• Retinitis Pigmentosa Syndrome

Interventions

Type	Name	Description
DRUG	EA-2353	EA-2353 Ophthalmic Suspension

Timeline

• Start date: 2022-06-02
• Primary completion: 2024-04-24
• Completion: 2024-04-24
• First posted: 2022-05-26
• Last updated: 2024-10-15

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study