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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
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. .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A - Dose 1 | Experimental |
| |
| Cohort A - Dose 2 | Experimental |
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| Cohort A - Dose 3 | Experimental |
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| Cohort B - Dose TBD | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OCU-10-C-110 for Injection | Drug | OCU-10-C-110 for Injection in one of 3 doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ocular safety - AE | Number of Adverse events | Cohort A - 8 weeks; Cohort B - 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Systemic safety - AE | Number of Adverse events | Cohort A - 8 weeks; Cohort B - 12 weeks |
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Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Roger Goldberg, MD | Lexitas Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Raj K. Maturi, M.D., P.C. | Carmel | Indiana | 46290 | United States | ||
| Retina Research Institute of Texas |
No sharing plans for this Phase 1 study at this time.
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Multi-center, open-label, two-part safety assessment
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| Abilene |
| Texas |
| 79606 |
| United States |
| Strategic Clinical Research Group LLC | Willow Park | Texas | 76087 | United States |
| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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