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Study terminated by the Sponsor. All study participants completed at least 12 months of safety follow-up instead of 24 mo. The reason for earlier termination was due to a corporate decision; not any safety concerns of EA-2353.
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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.
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:
Patient participation will last for approximately 25 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EA-2353 | Experimental | EA-2353 Ophthalmic Suspension will be administered via unilateral intravitreal injection into the Study Eye weekly for one month (4 injections) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EA-2353 | Drug | EA-2353 Ophthalmic Suspension |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events | through study completion at 24 months | |
| Incidence and severity of dose limiting toxicities (DLTs) | through study completion at 24 months | |
| Establish the maximum tolerated dose (MTD) as determined by occurrence of DLTs | through study completion at 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Moreno Menghini, MD | Endogena Therapeutics, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Endogena Site 005 | Miami | Florida | 33136 | United States | ||
| Endogena Site 003 |
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EA-2353 will be administered to all subjects during this study. It will be administered as 4 weekly intravitreal injections in the Study Eye.
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| Ann Arbor |
| Michigan |
| 48109 |
| United States |
| Endogena Site 004 | Portland | Oregon | 97232 | United States |
| Endogena Site 002 | Dallas | Texas | 75231 | United States |
| Endogena Site 001 | McAllen | Texas | 78503 | United States |
| ID | Term |
|---|---|
| D012174 | Retinitis Pigmentosa |
| C537612 | RHYNS syndrome |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D058499 | Retinal Dystrophies |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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