Macular Edema, Mellitus Diabetes
Conditions
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.
Interventions
RADIATIONMicropulsed laser photocoagulation
Micropulsed laser photocoagulation after 3 anti-VEGF injections
Sponsors
Fondation Ophtalmologique Adolphe de Rothschild
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of intra-vitreal anti-VEGF injections | One year |
Secondary
| Measure | Time frame |
|---|---|
| Time to reduction of the macular thickness | One year |
Countries
France
Outcome results
None listed