Sub-macular Injection of Ranibizumab as a New Surgical Treatment for Refractory Diabetic Macular Edema
|ClinicalTrials.gov Identifier: NCT03975088|
Recruitment Status : Completed
First Posted : June 5, 2019
Last Update Posted : June 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Macular Edema||Procedure: Sub-macular injection of Ranibizumab||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Sub-macular Injection of Ranibizumab as a New Surgical Treatment for Refractory Diabetic Macular Edema|
|Actual Study Start Date :||January 1, 2017|
|Actual Primary Completion Date :||December 31, 2017|
|Actual Study Completion Date :||December 31, 2018|
Persistent Diabetic macular edema
Authors defined refractory DME as eyes with persistent DME despite receiving at least 6 monthly Ranibizumab injections of anti VEGF, and then switched to Aflibercept, receiving at least three monthly injections.
Procedure: Sub-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.
- The primary endpoint for this study was the change in CMT at the final visit. [ Time Frame: at the 6 month follow up visit ]Central macular thickness