NCT00759044

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 24, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 25, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

October 15, 2015

Status Verified

October 1, 2015

Enrollment Period

2.6 years

First QC Date

September 24, 2008

Last Update Submit

October 13, 2015

Conditions

Age-Related MaculopathyDiabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

  • Blood-Retinal Barrier (BRB) function measured by Retinal Leakage Analysis (RLA).

Study Arms (2)

AMD

Patients diagnosed with AMD

DME

Patients diagnosed with DME

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AIBILI Clinical Trial Center

Coimbra, Coimbra District, 3000-548, Portugal

Location

Related 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. doi: 10.1109/TBME.2004.839801.

    PMID: 15651569BACKGROUND

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • José G Cunha-Vaz, Prof.

    Association for Innovation and Biomedical Research on Light and Image

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2008

First Posted

September 25, 2008

Study Start

March 1, 2008

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

October 15, 2015

Record last verified: 2015-10

Locations

PT(1)