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

NCT02650050 | Terminated

• 1 other identifier: GCO_2015_28
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Number of intra-vitreal anti-VEGF injections

  One year

Secondary Outcomes (1)

• Time to reduction of the macular thickness

  One year

Study Arms (2)

Micropulsed laser photocoagulation

EXPERIMENTAL

Radiation: Micropulsed laser photocoagulation

Sham micropulsed laser photocoagulation

SHAM COMPARATOR

Radiation: Micropulsed laser photocoagulation

Interventions

Micropulsed laser photocoagulation RADIATION

Micropulsed laser photocoagulation after 3 anti-VEGF injections

Micropulsed laser photocoagulation; Sham micropulsed laser photocoagulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

Fondation ophtalmique Adolphe de Rothschild

Paris, 75019, France

Location

MeSH Terms

Conditions

Macular Edema; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Georges CAPUTO

  Fondation ophtalmologique de Rothschild

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2016
• First Posted: January 8, 2016
• Study Start: January 19, 2016
• Primary Completion: June 4, 2019
• Study Completion: June 4, 2019
• Last Updated: June 17, 2019

Record last verified: 2019-06

Locations

FR (1)