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

Diabetic Macular Edema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00759044
• Other study ID #: CNTM023A
• Status: Completed
• Phase: N/A
• First received: September 24, 2008
• Last updated: October 13, 2015
• Start date: March 2008
• Est. completion date: October 2010

Study information

• Verified date: October 2015
• Source: Association for Innovation and Biomedical Research on Light and Image
• Contact: n/a
• Is FDA regulated: No
• Health authority: Portugal: AIBILI-Comissão de Ética para a Saúde
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Age-Related Maculopathy
• Diabetic Macular Edema
• Macular Edema

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, 

References & Publications (1)

Bernardes R, Dias J, Cunha-Vaz J. Mapping the human blood-retinal barrier function. IEEE Trans Biomed Eng. 2005 Jan;52(1):106-16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood-Retinal Barrier (BRB) function measured by Retinal Leakage Analysis (RLA).			No