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

Not Applicable

Terminated

• Conditions: Mellitus Diabetes; Macular Edema
• Interventions: Radiation: Micropulsed laser photocoagulation

• Registration Number: NCT02650050
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-01-07
• Study First Submitted QC: 2016-01-07
• Study First Posted: 2016-01-08
• Study Start: 2016-01-19
• Status Verified: 2019-06
• Primary Completion: 2019-06-04
• Study Completion: 2019-06-04
• Last Update Submitted: 2019-06-13
• Last Update Posted: 2019-06-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Micropulsed laser photocoagulation	Micropulsed laser photocoagulation	-
Sham micropulsed laser photocoagulation	Micropulsed laser photocoagulation	-

Primary Outcome Measures

Name	Time	Method
Number of intra-vitreal anti-VEGF injections	One year

Secondary Outcome Measures

Name	Time	Method
Time to reduction of the macular thickness	One year

Trial Locations

Locations (1)

Fondation ophtalmique Adolphe de Rothschild; 🇫🇷 Paris, France