Biomarkers of Diabetic Retinopathy Progression

Completed

• Conditions: Type 2 Diabetes Mellitus; Mild Nonproliferative Diabetic Retinopathy

• Registration Number: NCT01607190
• Lead Sponsor: Association for Innovation and Biomedical Research on Light and Image

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-05-23
• Study First Submitted QC: 2012-05-24
• Study First Posted: 2012-05-30
• Study Start: 2012-11
• Primary Completion: 2016-04
• Study Completion: 2017-12
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-18
• Last Update Posted: 2018-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CSME needing treatment either photocoagulation or ITV.	Months 0, 6, 12 and 24.

Secondary Outcome Measures

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

Trial Locations

Locations (2)

LV Prasad Eye Institute; 🇮🇳 Hyderabad, Andhra Pradesh, India

AIBILI- Association for Biomedical Research and Inovation on Light and Image.; 🇵🇹 Coimbra, Portugal