Ocular, Vascular, and Genetic Findings in AMD Patients

NCT06015633 | Active Not Recruiting

• 1 other identifier: OC-2301TV
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Observation of findings associated with AMD

Conditions

Age-Related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• OCT-A

  OCT-A metrics in subjects with AMD

  Baseline observation of incidence / correlation only

Secondary Outcomes (2)

• Genetic markers related to AMD

  Baseline observation of incidence / correlation only

• Magnetic Resonance Angiography

  Baseline observation of incidence / correlation only

Study Arms (2)

Exudative AMD

Subjects that have at least one eye with a history of, or active, exudative age related macular degeneration

Other: No intervention

Non-exudative AMD

Subjects that have at least one eye with late stage non-exudative age-related macular degeneration (presence of geographic atrophy)

Other: No intervention

Interventions

No intervention OTHER

Observational only

Exudative AMD; Non-exudative AMD

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects with exudative or non-exudative late-stage age-related macular degeneration.

You may qualify if:

• At least 55 years of age at the time of consent
• Able to understand and provide written informed consent
• Sufficiently clear ocular media, adequate pupillary dilation, and adequate fixation to permit quality fundus imaging
• Able to cooperate with ophthalmic visual function testing and anatomic assessments
• Willing to have protocol specified genetic testing
• Willing to have head coil MRI/A (with contrast if deemed necessary)

You may not qualify if:

• Ocular
• History of any retinal disease other than AMD in either eye
• Spherical equivalent refractive error demonstrating \>6 diopters of myopia or an axial length \>26 mm in the study eye
• History of vitrectomy in the study eye
• Any intraocular surgery (including lens replacement surgery) in the study eye, within 90 days of enrollment
• History of endophthalmitis
• Trabeculectomy or aqueous shunt or valve in the study eye
• Aphakia or absence of the posterior capsule in the study eye (Note: Previous violation of the posterior capsule is also excluded unless it occurred as a result of yttrium aluminum garnet \[YAG\] laser posterior capsulotomy in association with prior posterior chamber intraocular lens implantation and at least 90 days prior to enrollment)
• Presence of advanced guttae or visually significant keratopathy that would cause scattering of light or alter visual function in the study eye
• History of idiopathic or autoimmune-associated uveitis in either eye
• Active inflammation or infection, including conjunctivitis, keratitis, or scleritis in either eye
• GA secondary to a condition other than AMD (e.g., Stargardt's disease, cone rod dystrophy, or toxic maculopathies such as Plaquenil maculopathy) in either eye
• Non-Ocular
• Use of any investigational product or investigational medical device (i.e., not approved by FDA for the specific use) within 90 days prior to screening or anticipated use during the study
• Women of childbearing potential who are pregnant or unwilling to use effective contraception for the duration of the study

Sponsors & Collaborators

• OcuDyne, Inc.: lead

Study Sites (1)

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Luana Wilbur, BS

  OcuDyne VP, Clinical and Regulatory Affairs

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2023
• First Posted: August 29, 2023
• Study Start: October 15, 2023
• Primary Completion: February 1, 2025
• Study Completion: May 31, 2025
• Last Updated: February 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)