Mild Nonproliferative Diabetic Retinopathy, Type 2 Diabetes Mellitus
Conditions
Keywords
type 2 diabetes mellitus, nonproliferative diabetic retinopathy
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.
Interventions
None listed
Sponsors
Association for Innovation and Biomedical Research on Light and Image
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
35 Years to 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CSME needing treatment either photocoagulation or ITV. | Months 0, 6, 12 and 24. |
Secondary
| Measure | Time frame |
|---|---|
| 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. |
Countries
India, Portugal
Outcome results
None listed