Neovascular Age-related Macular Degeneration (nAMD)
Conditions
Keywords
neovascular age-related macular degeneration; intravitreal
Brief summary
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
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. .
Interventions
DRUGOCU-10-C-110 for Injection
OCU-10-C-110 for Injection in one of 3 doses
Sponsors
Ocugenix Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Multi-center, open-label, two-part safety assessment
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular safety - AE | Cohort A - 8 weeks; Cohort B - 12 weeks | Number of Adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Systemic safety - AE | Cohort A - 8 weeks; Cohort B - 12 weeks | Number of Adverse events |
Countries
United States
Contacts
STUDY_DIRECTORRoger Goldberg, MD
Lexitas Pharma
Outcome results
None listed