Clinical trial NCT05904691: Safety and Tolerability of OCU-10-C-110 for Injection in Subjects With Neovascular Age-related Macular Degeneration
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Neovascular Age-related Macular Degeneration (nAMD)
Keywords: neovascular age-related macular degeneration; intravitreal
Lead sponsor: Ocugenix Corporation
Sponsor class: INDUSTRY
First posted: 2023-06-15
Enrollment: 19
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Multi-center, open-label, two-part safety assessment
Primary purpose: TREATMENT

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. .

Eligibility criteria: 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

Primary outcomes:
measure: Ocular safety - AE
timeFrame: Cohort A - 8 weeks; Cohort B - 12 weeks
Secondary outcomes:
measure: Systemic safety - AE
timeFrame: Cohort A - 8 weeks; Cohort B - 12 weeks
Other outcomes:
Locations:
city: Carmel
country: United States
facility: Raj K. Maturi, M.D., P.C.
state: Indiana
city: Abilene
country: United States
facility: Retina Research Institute of Texas
state: Texas
city: Willow Park
country: United States
facility: Strategic Clinical Research Group LLC
state: Texas
Study officials:
affiliation: Lexitas Pharma
name: Roger Goldberg, MD
role: STUDY_DIRECTOR
References: