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

Macular Edema Clinical Trial

— LAMED  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02650050
• Other study ID #: GCO_2015_28
• Status: Terminated
• Phase: N/A
• Start date: January 19, 2016
• Est. completion date: June 4, 2019

Study information

• Verified date: June 2019
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: June 4, 2019
• Est. primary completion date: June 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Edema
• Macular Edema
• Mellitus Diabetes

Intervention

Radiation:
• Micropulsed laser photocoagulation
Micropulsed laser photocoagulation after 3 anti-VEGF injections

Locations

Country	Name	City	State
France	Fondation ophtalmique Adolphe de Rothschild	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of intra-vitreal anti-VEGF injections		One year
Secondary	Time to reduction of the macular thickness		One year