Characterization of Early Markers of Choroidal Neovascularization

Age-related Macular Degeneration Clinical Trial

— CNV-Markers  

Official title:

Characterization of Early Markers of Choroidal Neovascularization in Fellow Eyes of Patients With AMD and CNV in One Eye. (CNV-Markers)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00801541
• Other study ID #: CNTM326_A9010002
• Status: Completed
• Phase: N/A
• First received: December 2, 2008
• Last updated: March 18, 2015
• Start date: December 2005
• Est. completion date: June 2014

Study information

• Verified date: April 2014
• Source: Association for Innovation and Biomedical Research on Light and Image
• Contact: n/a
• Is FDA regulated: No
• Health authority: Portugal: Health Ethic Committee
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2014
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Age-related Macular Degeneration
• Choroidal Neovascularization
• Macular Degeneration
• Neovascularization, Pathologic

Locations

Country	Name	City	State
Portugal	AIBILI - Clinical Trial Center	Coimbra

Sponsors (1)

Lead Sponsor	Collaborator
Association for Innovation and Biomedical Research on Light and Image

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wet AMD development in the study eye.		Single Visit	Yes

External Links

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