Safety and tolerability of OCU-10-C-110 injection for 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)
This study is testing a new injectable treatment called OCU-10-C-110 to see if it is safe and well-tolerated for people with neovascular age-related macular degeneration.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 19 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Ocugenix Corporation Industry-sponsored |
| Locations | 3 sites (Carmel, Indiana and 2 other locations) |
| Trial ID | NCT05904691 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and tolerability of OCU-10-C-110, an injectable treatment for patients with neovascular age-related macular degeneration (nAMD). The study is divided into two parts: Part A involves administering a single intravitreal dose of the drug to participants, with dose escalation based on safety assessments. In Part B, participants will receive three doses of the maximally tolerated dose at four-week intervals, followed by a four-week observation period to monitor safety.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals with active choroidal neovascular lesions due to age-related macular degeneration who have recently received an anti-VEGF injection.
Not a fit: Patients with significant systemic or ophthalmic conditions that could compromise their safety or the study's integrity may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from nAMD, potentially improving vision and quality of life.
How similar studies have performed: While there have been studies on other treatments for nAMD, this specific approach with OCU-10-C-110 is novel and has not been previously tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Carmel, Indiana and 2 other locations
- Raj K. Maturi, M.D., P.C. — Carmel, Indiana, United States (Recruiting)
- Retina Research Institute of Texas — Abilene, Texas, United States (Recruiting)
- Strategic Clinical Research Group LLC — Willow Park, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Sean McDonald
- Email: sean@ocugenixtx.com
- Phone: (412) 600-6379
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.