An interventional study of Micropulsed laser photocoagulation in Macular Edema and Mellitus Diabetes, sponsored by Fondation Ophtalmologique Adolphe de Rothschild. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-06-17.
Sponsored by Fondation Ophtalmologique Adolphe de Rothschild · Not applicable, Interventional, and Treatment
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.
841 studies on the registry are indexed under Macular Edema; 56 are open to participants now.
This study's enrollment of 5 is below the median of 50 across 619 interventional studies indexed under Macular Edema.
Browse Macular Edema studies →Fondation Ophtalmologique Adolphe de Rothschild is the lead sponsor of 311 studies on the registry; 77 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Radiation: Micropulsed laser photocoagulation
Radiation: Micropulsed laser photocoagulation
Micropulsed laser photocoagulation after 3 anti-VEGF injections
Number of intra-vitreal anti-VEGF injections
Time frame: One year
Time to reduction of the macular thickness
Time frame: One year
This study is terminated, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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Fondation Ophtalmologique Adolphe de Rothschild