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

NCT02650050 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2019-06-17

No results posted yet for this study

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

Interventions

RADIATION

Micropulsed laser photocoagulation

Micropulsed laser photocoagulation after 3 anti-VEGF injections

Sponsors & Collaborators

  • Fondation Ophtalmologique Adolphe de Rothschild

    lead NETWORK

Principal Investigators

  • Georges CAPUTO · Fondation ophtalmologique de Rothschild

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-19
Primary Completion
2019-06-04
Completion
2019-06-04

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02650050 on ClinicalTrials.gov