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

Primary Purpose

Macular Edema, Mellitus Diabetes

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Micropulsed laser photocoagulation
Sponsored by
Fondation Ophtalmologique Adolphe de Rothschild
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Edema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Fondation ophtalmique Adolphe de Rothschild

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Micropulsed laser photocoagulation

Sham micropulsed laser photocoagulation

Arm Description

Outcomes

Primary Outcome Measures

Number of intra-vitreal anti-VEGF injections

Secondary Outcome Measures

Time to reduction of the macular thickness

Full Information

First Posted
January 7, 2016
Last Updated
June 13, 2019
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
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1. Study Identification

Unique Protocol Identification Number
NCT02650050
Brief Title
Micropulsed Laser in Association With Anti-VEGF for the Treatment of Macular Edema in Diabetic Patients (LAMED).
Acronym
LAMED
Official Title
Micropulsed Laser in Association With Intravitreal Injections of Anti-VEGF for the Treatment of Macular Edema in Diabetic Patients (LAMED).
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Terminated
Why Stopped
Number of eligible patients too low
Study Start Date
January 19, 2016 (Actual)
Primary Completion Date
June 4, 2019 (Actual)
Study Completion Date
June 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Ophtalmologique Adolphe de Rothschild

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Edema, Mellitus Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Micropulsed laser photocoagulation
Arm Type
Experimental
Arm Title
Sham micropulsed laser photocoagulation
Arm Type
Sham Comparator
Intervention Type
Radiation
Intervention Name(s)
Micropulsed laser photocoagulation
Intervention Description
Micropulsed laser photocoagulation after 3 anti-VEGF injections
Primary Outcome Measure Information:
Title
Number of intra-vitreal anti-VEGF injections
Time Frame
One year
Secondary Outcome Measure Information:
Title
Time to reduction of the macular thickness
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Georges CAPUTO
Organizational Affiliation
Fondation ophtalmologique de Rothschild
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondation ophtalmique Adolphe de Rothschild
City
Paris
ZIP/Postal Code
75019
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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