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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2026-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety and Tolerability of Intravitreal VEGF Trap Formulations in Subjects With Neovacular AMD

NCT00383370

Neovascular Age Related Macular Degeneration

COMPLETED PHASE1

Evaluating RXI-109 to Reduce the Progression of Subretinal Fibrosis in Subjects With NVAMD

NCT02599064

UNKNOWN PHASE1/PHASE2

Safety of BBC1501 Intravitreal Injection in Patients With Neovascular Age-Related Macular Degeneration (nAMD)

NCT05803785

Age-Related Macular Degeneration

RECRUITING PHASE1

Safety of 16.5 mg (3.3%) CGC-11047 Once Every 2 Weeks vs. Once Every 4 Weeks in Patients With CNV Due to AMD

NCT00446654

Age Related Macular Degeneration

COMPLETED PHASE1

A Pilot Study of the Safety of MC-1101 in Both Normal Volunteers and Patients With Early Dry AMD

NCT01013376

Age-Related Macular Degeneration

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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. .

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neovascular Age-related Macular Degeneration (nAMD)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Multi-center, open-label, two-part safety assessment

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No