Diabetic Macular Edema
Conditions
Brief summary
The best treatment strategy for refractory DME is not known, options include switching between anti-VEGF agents, corticosteroids, and vitrectomy. In this study, authors describe a new surgical technique for the treatment of refractory non tractional DME. The technique consists of vitrectomy with ILM peeling with subretinal injection of Ranibizumab.
Detailed description
Purpose: In this study, authors describe a new surgical technique for the treatment of refractory DME. The technique consists of vitrectomy with ILM peeling with subretinal injection of Ranibizumab. Methods: This is a prospective interventional non-comparative study including patients with refractory DME. Included patients were subjected to the new surgical technique of pars plana vitrectomy with sub-retinal injection of Ranibizumab.
Interventions
PROCEDURESub-macular injection of Ranibizumab
In this study, authors describe a new surgical technique for the treatment of refractory non tractional DME. The technique consists of vitrectomy with ILM peeling with subretinal injection of Ranibizumab.
Sponsors
University of Alexandria
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* refractory diffuse non tractional DME. * Central retinal thickness (CRT) should exceed 350 µm despite undergoing multiple anti-VEGF therapy. * Decimal best corrected visual acuity (BCVA) must be ≥0.01 and ≤0.5.
Exclusion criteria
* Previous vitrectomy, recent cataract surgery less than 6 months, * evident RPE atrophy, proliferative diabetic retinopathy, massive foveal hard exudation, foveal traction on OCT, * glaucoma and one eyed patients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary endpoint for this study was the change in CMT at the final visit. | at the 6 month follow up visit | Central macular thickness |
Outcome results
None listed