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

NCT05904691 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: OCU-10-C-110-CS101
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 3

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

Conditions

Neovascular Age-related Macular Degeneration (nAMD)

Keywords

neovascular age-related macular degeneration; intravitreal

Outcome Measures

Primary Outcomes (1)

• Ocular safety - AE

  Number of Adverse events

  Cohort A - 8 weeks; Cohort B - 12 weeks

Secondary Outcomes (1)

• Systemic safety - AE

  Cohort A - 8 weeks; Cohort B - 12 weeks

Study Arms (4)

Cohort A - Dose 1

EXPERIMENTAL

Drug: OCU-10-C-110 for Injection

Cohort A - Dose 2

EXPERIMENTAL

Drug: OCU-10-C-110 for Injection

Cohort A - Dose 3

EXPERIMENTAL

Drug: OCU-10-C-110 for Injection

Cohort B - Dose TBD

EXPERIMENTAL

Drug: OCU-10-C-110 for Injection

Interventions

OCU-10-C-110 for Injection DRUG

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

Cohort A - Dose 1; Cohort A - Dose 2; Cohort A - Dose 3; Cohort B - Dose TBD

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ocugenix Corporation: lead

Study Sites (3)

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

Carmel, Indiana, 46290, United States

Location

Retina Research Institute of Texas

Abilene, Texas, 79606, United States

Location

Strategic Clinical Research Group LLC

Willow Park, Texas, 76087, United States

Location

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Roger Goldberg, MD

  Lexitas Pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multi-center, open-label, two-part safety assessment

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: June 15, 2023
• Study Start: November 1, 2023
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)