Ocular, Vascular, and Genetic Findings in AMD Patients
Study Details
Study Description
Brief Summary
Observation of findings associated with AMD
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
Explorational observation of ocular, vascular, and genetic findings in patients diagnosed with AMD
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Exudative AMD Subjects that have at least one eye with a history of, or active, exudative age related macular degeneration |
Other: No intervention
Observational only
|
| 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
Observational only
|
Outcome Measures
Primary Outcome Measures
- OCT-A [Baseline observation of incidence / correlation only]
OCT-A metrics in subjects with AMD
Secondary Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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 Criteria:
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Tel Aviv Sourasky Medical Center | Tel Aviv | Israel |
Sponsors and Collaborators
- OcuDyne, Inc.
Investigators
- Study Director: Luana Wilbur, BS, OcuDyne VP, Clinical and Regulatory Affairs
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- OC-2301TV