Micropulsed Laser in Association With Anti-VEGF for the Treatment of Macular Edema in Diabetic Patients (LAMED).

Study Overview
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Brief Summary
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Diabetes is a major cause of blindness in adults in the developed countries. The retinal damages associated with diabetes lead to gradual loss of vision, which is accentuated when the macula is affected. This results in macular edema. Currently, intravitreal injections of anti-VEGF have demonstrated their effectiveness and are the first line treatment of macular edema. Subthreshold micropulsed laser photocoagulation is an alternative to conventional grid photocoagulation. By delivering pulsed impacts under the thermal lesion threshold of the pigment epithelium, it would not cause the side effects of conventional photocoagulation. Micropulsed photocoagulation combined to anti-VEGF injections, could be the most effective treatment with a minimum injection number and without epithelial lesions. The main objective of this study is to show that the subthreshold micropulsed laser photocoagulation, in association with intravitreal injections of anti-VEGF, allows to reduce the number of anti-VEGF injections during the first year of treatment. In this randomized, double blind study, eligible patients will be randomized between a micropulsed laser photocoagulation arm and a sham micropulsed laser photocoagulation arm.

Official Title
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Micropulsed Laser in Association With Intravitreal Injections of Anti-VEGF for the Treatment of Macular Edema in Diabetic Patients (LAMED).

Conditions
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Macular Edema, Mellitus Diabetes

Intervention / Treatment
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* Radiation: Micropulsed laser photocoagulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or more macular edema associated with a 1 or type 2 diabetes with a hemoglobin A1C level over 5.5% and under <13% indication for a treatment with intra-vitreal injections of ranibizumab Exclusion Criteria: treatment with anti-VEGF during the previous 2 months treatment by intra-vitreous implant of dexamethasone during the previous six months previous history of vitrectomy or glaucoma photocoagulation during the previous 3 months patient's opposition to participate to the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Micropulsed laser photocoagulation<br> | Radiation: Micropulsed laser photocoagulation<br>* Micropulsed laser photocoagulation after 3 anti-VEGF injections<br>|
| Sham Comparator: Sham micropulsed laser photocoagulation<br> | Radiation: Micropulsed laser photocoagulation<br>* Micropulsed laser photocoagulation after 3 anti-VEGF injections<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of intra-vitreal anti-VEGF injections |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to reduction of the macular thickness |  | One year |