Safety and Tolerability of OCU-10-C-110 for Injection in Subjects With Neovascular Age-related Macular Degeneration

Study Overview
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Brief Summary
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Multi-center, open-label, two-part safety assessment following administration of single ascending doses and repeat administration of the HTD of OCU-10-C-110 for Injection in the study eye of participants with nAMD

Detailed Description
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In Part A, subjects will receive a single intravitreal dose in a single eye of the drug product. Dose will be escalated in 3 successive cohorts, pending safety. In Part B, subjects will receive 3 treatments in a single eye of drug product at 4 week intervals of the maximally tolerated dose, with an additional 4 weeks of observation for safety. .

Official Title
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Safety and Tolerability of Single Ascending Doses and Multiple Repeat Doses of OCU-10-C-110 for Injection in Study Participants With Neovascular Age-related Macular Degeneration (nAMD)

Conditions
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Neovascular Age-related Macular Degeneration (nAMD)

Intervention / Treatment
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* Drug: OCU-10-C-110 for Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Angiographically documented active choroidal neovascular (CNV) lesion (i.e., leakage on fluorescein angiography or subretinal, intraretinal, or sub-retinal pigment epithelium [sub-RPE] fluid on spectral domain optical coherence tomography [SD-OCT]) secondary to age-related macular degeneration (AMD), within the previous 10 weeks Subjects must have received, 7 to 14 days prior to the Baseline Visit, an intravitreal injection in the study eye of an anti-vascular endothelial growth factor (VEGF) ocular therapeutic approved for use in the United States Exclusion Criteria: History or current evidence of a medical condition (systemic or ophthalmic disease, metabolic dysfunction, physical examination finding or clinical laboratory finding) that may, in the opinion of the investigator, preclude the safe administration of the study medication, adherence to the scheduled study visits, or safe participation in the study or affect the results of the study (e.g., unstable or progressive cardiovascular, cerebral vascular, pulmonary, Parkinson's, liver or renal disease, depression, cancer, or dementia) History or evidence of the following surgeries/procedures in the study eye: Submacular surgery Vitrectomy Retinal detachment or retinal tear Incisional glaucoma surgery

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Multi-center, open-label, two-part safety assessment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort A - Dose 1<br> | Drug: OCU-10-C-110 for Injection<br>* OCU-10-C-110 for Injection in one of 3 doses<br>|
| Experimental: Cohort A - Dose 2<br> | Drug: OCU-10-C-110 for Injection<br>* OCU-10-C-110 for Injection in one of 3 doses<br>|
| Experimental: Cohort A - Dose 3<br> | Drug: OCU-10-C-110 for Injection<br>* OCU-10-C-110 for Injection in one of 3 doses<br>|
| Experimental: Cohort B - Dose TBD<br> | Drug: OCU-10-C-110 for Injection<br>* OCU-10-C-110 for Injection in one of 3 doses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular safety - AE | Number of Adverse events | Cohort A - 8 weeks; Cohort B - 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systemic safety - AE | Number of Adverse events | Cohort A - 8 weeks; Cohort B - 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neovascular age-related macular degeneration; intravitreal