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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 30 March 2015
Main ID:  NCT00801541
Date of registration: 02/12/2008
Prospective Registration: No
Primary sponsor: Association for Innovation and Biomedical Research on Light and Image
Public title: Characterization of Early Markers of Choroidal Neovascularization CNV-Markers
Scientific title: Characterization of Early Markers of Choroidal Neovascularization in Fellow Eyes of Patients With AMD and CNV in One Eye. (CNV-Markers)
Date of first enrolment: December 2005
Target sample size: 60
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00801541
Study type:  Observational
Study design:  Observational Model: Cohort, Time Perspective: Prospective  
Phase:  N/A
Countries of recruitment
Portugal
Contacts
Name:     José Cunha-Vaz, MD PhD
Address: 
Telephone:
Email:
Affiliation:  Association for Innovation and Biomedical Research on Light and Image
Key inclusion & exclusion 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



Age minimum: 50 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Age-related Macular Degeneration
Intervention(s)
Primary Outcome(s)
Wet AMD development in the study eye. [Time Frame: Single Visit]
Secondary Outcome(s)
Secondary ID(s)
CNTM326_A9010002
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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