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

Neovascular Age-related Macular Degeneration (nAMD) Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05904691
• Other study ID #: OCU-10-C-110-CS101
• Status: Recruiting
• Phase: Phase 1
• Start date: November 1, 2023
• Est. completion date: May 1, 2025

Study information

• Verified date: November 2023
• Source: Ocugenix Corporation
• Contact: Sean McDonald
• Phone: (412) 600-6379
• Email: sean[@]ocugenixtx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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. .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 19
• Est. completion date: May 1, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular Age-related Macular Degeneration (nAMD)
• Wet Macular Degeneration

Intervention

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

Locations

Country	Name	City	State
United States	Retina Research Institute of Texas	Abilene	Texas
United States	Raj K. Maturi, M.D., P.C.	Carmel	Indiana
United States	Strategic Clinical Research Group LLC	Willow Park	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Ocugenix Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ocular safety - AE	Number of Adverse events	Cohort A - 8 weeks; Cohort B - 12 weeks
Secondary	Systemic safety - AE	Number of Adverse events	Cohort A - 8 weeks; Cohort B - 12 weeks