Ignite Creation Date:
2025-12-24 @ 5:23 PM
Ignite Modification Date:
2026-01-24 @ 2:12 AM
Study NCT ID:
NCT02650050
Status:
TERMINATED
Last Update Posted:
2019-06-17
First Post:
2016-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Micropulsed Laser in Association With Anti-VEGF for the Treatment of Macular Edema in Diabetic Patients (LAMED).
Sponsor:
Fondation Ophtalmologique Adolphe de Rothschild
Organization:
Study Overview
Official Title:
Micropulsed Laser in Association With Intravitreal Injections of Anti-VEGF for the Treatment of Macular Edema in Diabetic Patients (LAMED).
Status:
TERMINATED
Status Verified Date:
2019-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Number of eligible patients too low
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LAMED
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: