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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: February 25, 2013
Last verified: February 2013
History of Changes
  Purpose

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).


Condition
Age-related Macular Degeneration

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Characterization of Early Markers of Choroidal Neovascularization in Fellow Eyes of Patients With AMD and CNV in One Eye. (CNV-Markers)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Association for Innovation and Biomedical Research on Light and Image:

Primary Outcome Measures:
  • Wet AMD development in the study eye. [ Time Frame: --- ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: December 2005
Estimated Study Completion Date: June 2013
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
AMD
Patients with wet AMD in one eye and dry AMD in the other eye (study eye).

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00801541

Locations
Portugal
AIBILI - Clinical Trial Center
Coimbra, Portugal, 3000-548
Sponsors and Collaborators
Association for Innovation and Biomedical Research on Light and Image
Investigators
Principal Investigator: José Cunha-Vaz, MD PhD Association for Innovation and Biomedical Research on Light and Image
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Association for Innovation and Biomedical Research on Light and Image
ClinicalTrials.gov Identifier: NCT00801541     History of Changes
Other Study ID Numbers: CNTM326_A9010002
Study First Received: December 2, 2008
Last Updated: February 25, 2013
Health Authority: Portugal: Health Ethic Committee

Keywords provided by Association for Innovation and Biomedical Research on Light and Image:
AMD

Additional relevant MeSH terms:
Macular Degeneration
Neovascularization, Pathologic
Choroidal Neovascularization
Retinal Degeneration
Retinal Diseases
 Eye Diseases
Metaplasia
Pathologic Processes
Choroid Diseases
Uveal Diseases

ClinicalTrials.gov processed this record on May 16, 2013