Characterization of Early Markers of Choroidal Neovascularization
CNV-Markers
1 other identifier
observational
60
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Dec 2005
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 2, 2008
CompletedFirst Posted
Study publicly available on registry
December 3, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedMarch 19, 2015
April 1, 2014
3 years
December 2, 2008
March 18, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Wet AMD development in the study eye.
Single Visit
Study Arms (1)
AMD
Patients with wet AMD in one eye and dry AMD in the other eye (study eye).
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
AIBILI - Clinical Trial Center
Coimbra, Coimbra District, 3000-548, Portugal
Related Publications (1)
Marques JP, Costa M, Melo P, Oliveira CM, Pires I, Cachulo ML, Figueira J, Silva R. Ocular Risk Factors for Exudative AMD: A Novel Semiautomated Grading System. ISRN Ophthalmol. 2013 Jul 30;2013:464218. doi: 10.1155/2013/464218. eCollection 2013.
PMID: 24555130DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
José Cunha-Vaz, MD PhD
Association for Innovation and Biomedical Research on Light and Image
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 2, 2008
First Posted
December 3, 2008
Study Start
December 1, 2005
Primary Completion
December 1, 2008
Study Completion
June 1, 2014
Last Updated
March 19, 2015
Record last verified: 2014-04