ClinicalTrialsFinder
RecruitingPhase 1NCT05904691

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

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)

Sponsor

Ocugenix Corporation

Enrollment

19 participants

Start Date

Nov 1, 2023

Study Type

INTERVENTIONAL

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

Eligibility

Min Age: 50 Years

Inclusion Criteria2

  • 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 Criteria6

  • 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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGOCU-10-C-110 for Injection

OCU-10-C-110 for Injection in one of 3 doses

Locations(3)

Raj K. Maturi, M.D., P.C.

Carmel, Indiana, United States

Retina Research Institute of Texas

Abilene, Texas, United States

Strategic Clinical Research Group LLC

Willow Park, Texas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05904691