NCT00840541

Brief Summary

The purpose of this study is to validate and characterize phenotypes of diabetic retinopathy (DR) progression based on available clinical data (demographic, systemic and ophthalmic data).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2009

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

January 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 9, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 10, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

April 7, 2014

Status Verified

April 1, 2014

Enrollment Period

1 year

First QC Date

February 9, 2009

Last Update Submit

April 4, 2014

Conditions

Diabetic Retinopathy

Outcome Measures

Primary Outcomes (1)

  • CSME

    1 year

Study Arms (1)

DR

Type-2 diabetic subjects diagnosed with diabetic retinopathy (DR).

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Type-2 diabetic subjects diagnosed with DR, followed regularly by their ophthalmologist at the AIBILI Clinical Trial Center, with a previous follow-up in which systemic data and ophthalmological examinations were performed regularly.

You may qualify if:

  • Diagnosis of DR.
  • Females or Males;
  • Age over 18 years;
  • Signed Informed Consent;
  • Previous follow-up with regular systemic and ophthalmic assessments.

You may not qualify if:

  • Cataract or other eye disease that may interfere with fundus examinations;
  • Vitreous syneresis or posterior vitreous detachment;
  • 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)

  • Cunha-Vaz J. Characterization and relevance of different diabetic retinopathy phenotypes. Dev Ophthalmol. 2007;39:13-30. doi: 10.1159/000098497.

    PMID: 17245076BACKGROUND

Related Links

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Officials

  • José Cunha-Vaz, MD PhD

    Association for Innovation and Biomedical Research on Light and Image

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 9, 2009

First Posted

February 10, 2009

Study Start

January 1, 2009

Primary Completion

January 1, 2010

Study Completion

January 1, 2012

Last Updated

April 7, 2014

Record last verified: 2014-04

Locations

PT(1)