Characterization of Early Markers of Choroidal Neovascularization

Overview

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).

Full Title of Study: “Characterization of Early Markers of Choroidal Neovascularization in Fellow Eyes of Patients With AMD and CNV in One Eye. (CNV-Markers)”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 2008

Detailed Description

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.

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Wet AMD development in the study eye.
    • Time Frame: Single Visit

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Association for Innovation and Biomedical Research on Light and Image
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • José Cunha-Vaz, MD PhD, Principal Investigator, Association for Innovation and Biomedical Research on Light and Image

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