Biomarkers of Diabetic Retinopathy Progression

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-11-30

Study Completion Date

2017-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Type 2 Diabetes Mellitus Mild Nonproliferative Diabetic Retinopathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with diabetic retinopathy.

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

35 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No