Biomarkers of Diabetic Retinopathy Progression (C-Tracer)

July 18, 2018 updated by: Association for Innovation and Biomedical Research on Light and Image

Biomarkers of Diabetic Retinopathy Progression.

The purpose of this study is to validate a predictive model of diabetic retinopathy progression in patients with diabetes mellitus type 2 patients to clinically significant macular edema (CSME) needing treatment either photocoagulation or intravitreal injections (ITV) using non-invasive techniques.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500 034
        • LV Prasad Eye Institute
  • Portugal
      • Coimbra, Portugal, 3000-548
        • AIBILI- Association for Biomedical Research and Inovation on Light and Image.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with type 2 diabetes mellitus and mild nonproliferative diabetic retinopathy

Description

Inclusion Criteria:

  • Type 2 diabetes mellitus
  • Age over 35 years-old
  • Non-proliferative diabetic retinopathy (Levels 20 to 35, according the ETDRS criteria)
  • Best Corrected Visual Acuity > 20/25 on the ETDRS chart
  • Informed Consent

Exclusion Criteria:

  • Previous laser therapy
  • Other retinal vascular disease
  • Glaucoma
  • Recent intraocular surgery (in the last 6 months)
  • Inadequate ocular media and/ or pupil dilatation that do not permit good quality fundus photography (e.g. cataract)
  • HbA1C > 11 % at the Screening
  • Subject that has a condition or that is in a situation which may put him/her at significant risk, may confound the study results or may interfere significantly with his/ her participation in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients with diabetic retinopathy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
CSME needing treatment either photocoagulation or ITV.
Time Frame: Months 0, 6, 12 and 24.
Months 0, 6, 12 and 24.

Secondary Outcome Measures

Outcome Measure
Time Frame
Best corrected visual acuity.
Time Frame: Months 0, 6, 12 and 24.
Months 0, 6, 12 and 24.
Vision loss of at least 2 lines documented in ETDRS charts
Time Frame: Months 0, 6, 12 and 24.
Months 0, 6, 12 and 24.
Central retinal thickness
Time Frame: Months 0, 6, 12 and 24.
Months 0, 6, 12 and 24.
Microaneurysm(MA) activity (number of MA, MA formation and MA disappearance rates and MA turnover)
Time Frame: Months 0, 6, 12 and 24.
Months 0, 6, 12 and 24.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Association for Innovation and Biomedical Research on Light and Image

Investigators

  • Study Chair: José Cunha-Vaz, MD, PhD, Association for Innovation and Biomedical Research on Light and Image

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

May 23, 2012

First Submitted That Met QC Criteria

May 24, 2012

First Posted (Estimate)

May 30, 2012

Study Record Updates

Last Update Posted (Actual)

July 19, 2018

Last Update Submitted That Met QC Criteria

July 18, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4C-2012-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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