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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Association for Innovation and Biomedical Research on Light and Image
ClinicalTrials.gov Identifier:
NCT00759044
First received: September 24, 2008
Last updated: October 13, 2015
Last verified: October 2015
  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

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 ]

Enrollment: 90
Study Start Date: March 2008
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Association for Innovation and Biomedical Research on Light and Image
ClinicalTrials.gov Identifier: NCT00759044     History of Changes
Other Study ID Numbers: CNTM023A 
Study First Received: September 24, 2008
Last Updated: October 13, 2015
Health Authority: Portugal: AIBILI-Comissão de Ética para a Saúde

Additional relevant MeSH terms:
Macular Edema
Eye Diseases
Macular Degeneration
Retinal Degeneration
Retinal Diseases

ClinicalTrials.gov processed this record on May 03, 2016