Characterization of Early Markers of Choroidal Neovascularization (CNV-Markers)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Association for Innovation and Biomedical Research on Light and Image
ClinicalTrials.gov Identifier:
NCT00801541
First received: December 2, 2008
Last updated: April 9, 2014
Last verified: April 2014

December 2, 2008
April 9, 2014
December 2005
December 2008   (final data collection date for primary outcome measure)
Wet AMD development in the study eye. [ Time Frame: --- ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00801541 on ClinicalTrials.gov Archive Site
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Characterization of Early Markers of Choroidal Neovascularization
Characterization of Early Markers of Choroidal Neovascularization in Fellow Eyes of Patients With AMD and CNV in One Eye. (CNV-Markers)

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).

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Patients of either sex, any race, aged over 50 years and over, diagnosed with exudative (wet) AMD in one eye (non-study eye) and non-exudative (dry) AMD (intermediate or large/confluent drusen, with hyperpigmentation, and no CNV or geographic atrophy) in the other eye (study eye) that is at risk for progressing to exudative (wet) AMD and meet all the inclusion and exclusion criteria.

Age-related Macular Degeneration
Not Provided
AMD
Patients with wet AMD in one eye and dry AMD in the other eye (study eye).
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
June 2014
December 2008   (final data collection date for primary outcome measure)

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
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Portugal
 
NCT00801541
CNTM326_A9010002
Yes
Association for Innovation and Biomedical Research on Light and Image
Association for Innovation and Biomedical Research on Light and Image
Not Provided
Principal Investigator: José Cunha-Vaz, MD PhD Association for Innovation and Biomedical Research on Light and Image
Association for Innovation and Biomedical Research on Light and Image
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP