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

Ocugenix

Status and phase: Enrolling; Phase 1

Conditions: Neovascular Age-related Macular Degeneration (nAMD)

Treatments: Drug: OCU-10-C-110 for Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT05904691

OCU-10-C-110-CS101

Details and patient eligibility

About

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

Full description

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. .

Enrollment: 19 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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
2. 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

1. 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)

2. History or evidence of the following surgeries/procedures in the study eye:

   1. Submacular surgery
   2. Vitrectomy
   3. Retinal detachment or retinal tear
   4. Incisional glaucoma surgery

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 4 patient groups

Cohort A - Dose 1

Experimental group

Treatment:

Drug: OCU-10-C-110 for Injection

Cohort A - Dose 2

Experimental group

Treatment:

Drug: OCU-10-C-110 for Injection

Cohort A - Dose 3

Experimental group

Treatment:

Drug: OCU-10-C-110 for Injection

Cohort B - Dose TBD

Experimental group

Treatment:

Drug: OCU-10-C-110 for Injection