Clinical trial NCT00801541: Characterization of Early Markers of Choroidal Neovascularization
Official title: Characterization of Early Markers of Choroidal Neovascularization in Fellow Eyes of Patients With AMD and CNV in One Eye. (CNV-Markers)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Age-related Macular Degeneration
Keywords: AMD
Lead sponsor: Association for Innovation and Biomedical Research on Light and Image
Sponsor class: OTHER
First posted: 2008-12-03
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).

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 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

Primary outcomes:
measure: Wet AMD development in the study eye.
timeFrame: Single Visit
Secondary outcomes:
Other outcomes:
Locations:
city: Coimbra
country: Portugal
facility: AIBILI - Clinical Trial Center
Study officials:
affiliation: Association for Innovation and Biomedical Research on Light and Image
name: José Cunha-Vaz, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.