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Observation of findings associated with AMD
Explorational observation of ocular, vascular, and genetic findings in patients diagnosed with AMD
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exudative AMD | Subjects that have at least one eye with a history of, or active, exudative age related macular degeneration |
| |
| Non-exudative AMD | Subjects that have at least one eye with late stage non-exudative age-related macular degeneration (presence of geographic atrophy) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | Observational only |
|
| Measure | Description | Time Frame |
|---|---|---|
| OCT-A | OCT-A metrics in subjects with AMD | Baseline observation of incidence / correlation only |
| Measure | Description | Time Frame |
|---|---|---|
| Genetic markers related to AMD | Presence of 52 known AMD related genetic markers | Baseline observation of incidence / correlation only |
| Magnetic Resonance Angiography | Ophthalmic artery MRI / MRA results in subjects with AMD |
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Inclusion Criteria:
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
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Subjects with exudative or non-exudative late-stage age-related macular degeneration.
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| Name | Affiliation | Role |
|---|---|---|
| Luana Wilbur, BS | OcuDyne VP, Clinical and Regulatory Affairs | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tel Aviv Sourasky Medical Center | Tel Aviv | Israel |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| Baseline observation of incidence / correlation only |