CompletedNot Applicable

Biomarkers of Diabetic Retinopathy Progression

India, Portugal200 participantsStarted 2012-11

Plain-language 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.

Who can participate

Age range35 Years – 100 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

CSME needing treatment either photocoagulation or ITV.

Timeframe: Months 0, 6, 12 and 24.

Trial details

NCT IDNCT01607190

SponsorAssociation for Innovation and Biomedical Research on Light and Image

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2016-04

View on ClinicalTrials.gov More Type 2 Diabetes Mellitus trials