Characterization of Early Markers of Choroidal Neovascularization

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-12-31

Study Completion Date

2014-06-30

Brief Summary

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To this study and identify the sequence of alterations occurring in the chorioretinal interface during progression of AMD from "dry" AMD to sight-threatening chorioretinal neovascularization (CNV).

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Detailed Description

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The primary statistical objective of this study is to identify the sequence of alterations occurring in the chorioretinal interface during progression of AMD from risk "dry" AMD to sight-threatening chorioretinal neovascularization (CNV) (wet AMD).

Different imaging methods will be used simultaneously and at regular intervals in order to characterize markers or predictors of conversion to sight-threatening CNV will be: CNV (classic or occult) or position of CNV within 2500 µm (\~1.7 disc diameters) of the foveal center, as evidenced by fluorescein angiography.

This is an institutional, prospective, observation study to be performed in fellow eyes of patients with evidence of "wet" AMD in other eye. Therefore, patients will have evidence of exudative ("wet") AMD in one eye ( the non-study eye) and non-exudative ("dry") AMD in the fellow eye (the study eye) that is at risk for progressive to exudation "wet" CNV.

Patients will exit the study at the time of developing sight-threatening CNV in the study eye and will be treated at the discretion of the physician.

Conditions

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Age-related Macular Degeneration

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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AMD

Patients with wet AMD in one eye and dry AMD in the other eye (study eye).

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Written informed consent
* Age over 50 years
* Any race and any sex
* Clinical diagnosis of exudative AM;D in one eye (non-stud eye) and the presence of the following characteristics in the second eye (study eye, eye to be treated):

* At least 5 or more intermediate (\> 63 µm) or larger soft drusen AND/OR Confluent drusen within 3000 µm of the fovea center
* Hyperpigmentation

Exclusion Criteria

* History of medical condition that would preclude scheduled study visits
* History of ophthalmic disease in the study eye other than AMD
* Clinical signs of myopic retinopathy, or refraction higher than -8 diopter power.
* Intraocular surgery in the study eye within 60 days prior enrollement
* Evidence of past or present CNV in the study eye

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No