Status:
ACTIVE_NOT_RECRUITING
Ocular, Vascular, and Genetic Findings in AMD Patients
Lead Sponsor:
OcuDyne, Inc.
Conditions:
Age-Related Macular Degeneration
Eligibility:
All Genders
55+ years
Brief Summary
Observation of findings associated with AMD
Detailed Description
Explorational observation of ocular, vascular, and genetic findings in patients diagnosed with AMD
Eligibility Criteria
Inclusion
- 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
- 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)
- Willing to have protocol specified genetic testing
- Willing to have head coil MRI/A (with contrast if deemed necessary)
Exclusion
- 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
- Acute or serious illness, in the opinion of the site investigator
- History of kidney failure or gadolinium toxicity
Key Trial Info
Start Date :
October 15 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 31 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06015633
Start Date
October 15 2023
End Date
May 31 2025
Last Update
February 21 2025
Active Locations (1)
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1
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel