Late-Onset Retinal Degeneration Clinical Trials

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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)

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:

• 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

Locations
United States
Indiana
Raj K. Maturi, M.D., P.C.
RECRUITING
Carmel
Texas
Retina Research Institute of Texas
RECRUITING
Abilene
Strategic Clinical Research Group LLC
RECRUITING
Willow Park
Contact Information
Primary
Sean McDonald
sean@ocugenixtx.com
(412) 600-6379
Time Frame
Start Date: 2023-11-01
Estimated Completion Date: 2026-11-30
Participants
Target number of participants: 19
Treatments
Experimental: Cohort A - Dose 1
Experimental: Cohort A - Dose 2
Experimental: Cohort A - Dose 3
Experimental: Cohort B - Dose TBD
Sponsors
Leads: Ocugenix Corporation

This content was sourced from clinicaltrials.gov

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