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

Fondation Ophtalmologique Adolphe de Rothschild

Status: Terminated

Conditions: Macular Edema; Mellitus Diabetes

Treatments: Radiation: Micropulsed laser photocoagulation

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT02650050

GCO_2015_28

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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5 participants in 2 patient groups

Micropulsed laser photocoagulation

Experimental group

Treatment:

Radiation: Micropulsed laser photocoagulation

Sham micropulsed laser photocoagulation

Sham Comparator group

Treatment:

Radiation: Micropulsed laser photocoagulation