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Completed

NCT Number: NCT00801541

Characterization of Early Markers of Choroidal Neovascularization

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).

Completed

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AIBILI - Clinical Trial Center

Coimbra, Coimbra District, 3000-548, Portugal

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Wet AMD development in the study eye.

    Time frame: Single Visit

Sponsors and collaborators

Lead sponsor

Association for Innovation and Biomedical Research on Light and Image

Other

Registry information

Official study title

Characterization of Early Markers of Choroidal Neovascularization in Fellow Eyes of Patients With AMD and CNV in One Eye. (CNV-Markers)

Acronym: CNV-Markers

Important dates

Study start
2005
Primary completion
2008
Study completion
2014
First posted
Dec 3, 2008
Registry last updated
Mar 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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