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

NCT ID: NCT02650050

Last Updated: 2019-06-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-19
• Study Completion Date: 2019-06-04

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.

Conditions

Macular Edema; Mellitus Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Micropulsed laser photocoagulation

Group Type: EXPERIMENTAL

Micropulsed laser photocoagulation

Intervention Type: RADIATION

Micropulsed laser photocoagulation after 3 anti-VEGF injections

Sham micropulsed laser photocoagulation

Group Type: SHAM_COMPARATOR

Micropulsed laser photocoagulation

Intervention Type: RADIATION

Micropulsed laser photocoagulation after 3 anti-VEGF injections

Interventions

Micropulsed laser photocoagulation

Micropulsed laser photocoagulation after 3 anti-VEGF injections

Intervention Type: RADIATION

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Georges CAPUTO

Role: PRINCIPAL_INVESTIGATOR

Fondation ophtalmologique de Rothschild

Locations

Fondation ophtalmique Adolphe de Rothschild

Paris, , France

Countries

France

Other Identifiers

GCO_2015_28

Identifier Type: -

Identifier Source: org_study_id