Characterization of Early Markers of Choroidal Neovascularization

Completed

• Conditions: Age-related Macular Degeneration

• Registration Number: NCT00801541
• Lead Sponsor: Association for Innovation and Biomedical Research on Light and Image

Brief Summary

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).

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.

Study Timeline

• Study Start: 2005-12
• Primary Completion: 2008-12
• Study First Submitted: 2008-12-02
• Study First Submitted QC: 2008-12-02
• Study First Posted: 2008-12-03
• Status Verified: 2014-04
• Study Completion: 2014-06
• Last Update Submitted: 2015-03-18
• Last Update Posted: 2015-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Wet AMD development in the study eye.	Single Visit

Trial Locations

Locations (1)

AIBILI - Clinical Trial Center; 🇵🇹 Coimbra, Portugal