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

This study has been completed.
Sponsor:
Information provided by:
Association for Innovation and Biomedical Research on Light and Image
ClinicalTrials.gov Identifier:
NCT00759044
First received: September 24, 2008
Last updated: October 13, 2010
Last verified: October 2010
History of Changes
  Purpose

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


Condition
Age-Related Maculopathy
Diabetic Macular Edema

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of a New Methodology for Mapping the Human Blood-Retinal Barrier Function

Resource links provided by NLM:

MedlinePlus related topics: Edema
U.S. FDA Resources

Further study details as provided by Association for Innovation and Biomedical Research on Light and Image:

Primary Outcome Measures:
  • Blood-Retinal Barrier (BRB) function measured by Retinal Leakage Analysis (RLA). [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: March 2008
Study Completion Date: October 2010
Groups/Cohorts
AMD
Patients diagnosed with AMD
DME
Patients diagnosed with DME

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients with AMD or DME followed regularly by their ophthalmologist at the AIBILI Clinical Trial Center will be asked to perform additional optical examinations as a continuation of the routine fluorescein angiographies (FA).

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00759044

Locations
Portugal
AIBILI Clinical Trial Center
Coimbra, Portugal, 3000-548
Sponsors and Collaborators
Association for Innovation and Biomedical Research on Light and Image
Investigators
Principal Investigator: José G Cunha-Vaz, Prof. Association for Innovation and Biomedical Research on Light and Image
  More Information

Publications:

Responsible Party: Prof. José G Cunha-Vaz, AIBILI
ClinicalTrials.gov Identifier: NCT00759044     History of Changes
Other Study ID Numbers: CNTM023A
Study First Received: September 24, 2008
Last Updated: October 13, 2010
Health Authority: Portugal: AIBILI-Comissão de Ética para a Saúde

Additional relevant MeSH terms:
Edema
Macular Edema
Macular Degeneration
Signs and Symptoms
 Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 22, 2013