Validation of a New Methodology for Mapping the Human Blood-Retinal Barrier Function

Completed

• Conditions: Age-Related Maculopathy; Diabetic Macular Edema

• Registration Number: NCT00759044
• Lead Sponsor: Association for Innovation and Biomedical Research on Light and Image

Brief Summary

To validate a new methodology, named Retinal Leakage Analysis (RLA), for mapping the human Blood-Retinal Barrier (BRB) function, in the clinical practice.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-09-24
• Study First Submitted QC: 2008-09-24
• Study First Posted: 2008-09-25
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-13
• Last Update Posted: 2015-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Patients diagnosed with AMD, or
• Patients diagnosed with DME
• Age over 18 years
• Inform consent

Exclusion Criteria

• Cataract or other eye disease that may interfere with fundus examinations
• Glaucoma
• Dilatation of the pupil < 5 mm

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blood-Retinal Barrier (BRB) function measured by Retinal Leakage Analysis (RLA).

Trial Locations

Locations (1)

AIBILI Clinical Trial Center; 🇵🇹 Coimbra, Portugal