Ocular, Vascular, and Genetic Findings in AMD Patients

Age-Related Macular Degeneration Clinical Trial

Official title:

Exploration of Ocular, Vascular, and Genetic Findings Associated and Correlated With the Presence of Late-stage AMD

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06015633
• Other study ID #: OC-2301TV
• Status: Recruiting
• Start date: October 15, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: OcuDyne, Inc.
• Contact: Luana Wilbur, BS
• Phone: 01-858-442-7178
• Email: lwilbur[@]ocudyne.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Observation of findings associated with AMD

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Macular Degeneration

Intervention

Other:
• No intervention
Observational only

Locations

Country	Name	City	State
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
OcuDyne, Inc.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OCT-A	OCT-A metrics in subjects with AMD	Baseline observation of incidence / correlation only
Secondary	Genetic markers related to AMD	Presence of 52 known AMD related genetic markers	Baseline observation of incidence / correlation only
Secondary	Magnetic Resonance Angiography	Ophthalmic artery MRI / MRA results in subjects with AMD	Baseline observation of incidence / correlation only