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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Mild Nonproliferative Diabetic Retinopathy Nutritional and Metabolic Diseases

Age range

35 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

LV Prasad Eye Institute, Hyderabad, Andhra Pradesh, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

CSME needing treatment either photocoagulation or ITV.

Time frame: Months 0, 6, 12 and 24.

Secondary outcomes

Best corrected visual acuity.

Time frame: 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.
Central retinal thickness

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Association for Innovation and Biomedical Research on Light and Image

Other

Registry information

Official study title

Biomarkers of Diabetic Retinopathy Progression.

Acronym: C-Tracer

Important dates

Study start: 2012
Primary completion: 2016
Study completion: 2017
First posted: May 30, 2012
Registry last updated: Jul 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed