RECRUITING

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

Conditions

Neovascular Age-related Macular Degeneration (nAMD)neovascular age-related macular degeneration; intravitreal

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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)

Quick Facts

Study Start:2023-11-01

Study Completion:2025-05-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05904691

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Study Contact

Sean McDonald

CONTACT

(412) 600-6379

sean@ocugenixtx.com

Principal Investigator

Roger Goldberg, MD

STUDY_DIRECTOR

Lexitas Pharma

Study Locations (Sites)

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

Carmel, Indiana, 46290

United States

Retina Research Institute of Texas

Abilene, Texas, 79606

United States

Strategic Clinical Research Group LLC

Willow Park, Texas, 76087

United States

Collaborators and Investigators

Sponsor: Ocugenix Corporation

Roger Goldberg, MD, STUDY_DIRECTOR, Lexitas Pharma

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-01

Study Completion Date2025-05-01

Study Record Updates

Study Start Date2023-11-01

Study Completion Date2025-05-01

Terms related to this study

Keywords Provided by Researchers

neovascular age-related macular degeneration; intravitreal

Additional Relevant MeSH Terms

Neovascular Age-related Macular Degeneration (nAMD)