Overview

This trial is active, not recruiting.

Conditions type 2 diabetes mellitus, mild nonproliferative diabetic retinopathy
Sponsor Association for Innovation and Biomedical Research on Light and Image
Start date November 2012
End date April 2016
Trial size 200 participants
Trial identifier NCT01607190, 4C-2012-02

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm

Primary Outcomes

Measure
CSME needing treatment either photocoagulation or ITV.
time frame: Months 0, 6, 12 and 24.

Secondary Outcomes

Measure
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.

Eligibility Criteria

Male or female participants from 35 years up to 100 years old.

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.

Additional Information

Official title Biomarkers of Diabetic Retinopathy Progression.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Association for Innovation and Biomedical Research on Light and Image.