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: * 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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
14
EA-2353 Ophthalmic Suspension
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
Incidence and severity of adverse events
Time frame: through study completion at 24 months
Incidence and severity of dose limiting toxicities (DLTs)
Time frame: through study completion at 24 months
Establish the maximum tolerated dose (MTD) as determined by occurrence of DLTs
Time frame: through study completion at 24 months
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Endogena Site 001
McAllen, Texas, United States