Age-Related Macular Degeneration
Conditions
Brief summary
Observation of findings associated with AMD
Detailed description
Explorational observation of ocular, vascular, and genetic findings in patients diagnosed with AMD
Interventions
OTHERNo intervention
Observational only
Sponsors
OcuDyne, Inc.
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| OCT-A | Baseline observation of incidence / correlation only | OCT-A metrics in subjects with AMD |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Genetic markers related to AMD | Baseline observation of incidence / correlation only | Presence of 52 known AMD related genetic markers |
| Magnetic Resonance Angiography | Baseline observation of incidence / correlation only | Ophthalmic artery MRI / MRA results in subjects with AMD |
Countries
Israel
Outcome results
None listed