Ocular, Vascular, and Genetic Findings in AMD Patients

Active, not recruiting

• Conditions: Age-Related Macular Degeneration
• Interventions: Other: No intervention

• Registration Number: NCT06015633
• Lead Sponsor: OcuDyne, Inc.

Brief Summary

Observation of findings associated with AMD

Detailed Description

Explorational observation of ocular, vascular, and genetic findings in patients diagnosed with AMD

Study Timeline

• Study First Submitted: 2023-08-23
• Study First Submitted QC: 2023-08-23
• Study First Posted: 2023-08-29
• Study Start: 2023-10-15
• Status Verified: 2025-02
• Primary Completion: 2025-02-01
• Last Update Submitted: 2025-02-19
• Last Update Posted: 2025-02-21
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. At least 55 years of age at the time of consent
2. Able to understand and provide written informed consent
3. Sufficiently clear ocular media, adequate pupillary dilation, and adequate fixation to permit quality fundus imaging
4. Able to cooperate with ophthalmic visual function testing and anatomic assessments
5. Diagnosed with late-stage AMD in at least one eye. (if both eyes of an eligible subject meet inclusion criterion, the more advanced eye will receive primary eye assignment)
6. Willing to have protocol specified genetic testing
7. Willing to have head coil MRI/A (with contrast if deemed necessary)

Exclusion Criteria

Ocular

1. History of any retinal disease other than AMD in either eye

2. Spherical equivalent refractive error demonstrating >6 diopters of myopia or an axial length >26 mm in the study eye

3. History of vitrectomy in the study eye

4. Any intraocular surgery (including lens replacement surgery) in the study eye, within 90 days of enrollment

5. History of endophthalmitis

6. Trabeculectomy or aqueous shunt or valve in the study eye

7. 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)

8. Presence of advanced guttae or visually significant keratopathy that would cause scattering of light or alter visual function in the study eye

9. History of idiopathic or autoimmune-associated uveitis in either eye

10. Active inflammation or infection, including conjunctivitis, keratitis, or scleritis in either eye

11. 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

12. 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

13. Women of childbearing potential who are pregnant or unwilling to use effective contraception for the duration of the study

14. Acute or serious illness, in the opinion of the site investigator

15. History of kidney failure or gadolinium toxicity

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Exudative AMD	No intervention	Subjects that have at least one eye with a history of, or active, exudative age related macular degeneration
Non-exudative AMD	No intervention	Subjects that have at least one eye with late stage non-exudative age-related macular degeneration (presence of geographic atrophy)

Primary Outcome Measures

Name	Time	Method
OCT-A	Baseline observation of incidence / correlation only	OCT-A metrics in subjects with AMD

Secondary Outcome Measures

Name	Time	Method
Magnetic Resonance Angiography	Baseline observation of incidence / correlation only	Ophthalmic artery MRI / MRA results in subjects with AMD
Genetic markers related to AMD	Baseline observation of incidence / correlation only	Presence of 52 known AMD related genetic markers

Trial Locations

Locations (1)

Tel Aviv Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel