Sub-macular Injection of Ranibizumab as a New Surgical Treatment for Refractory Diabetic Macular Edema

Not Applicable

Completed

• Conditions: Diabetic Macular Edema
• Interventions: Procedure: Sub-macular injection of Ranibizumab

• Registration Number: NCT03975088
• Lead Sponsor: University of Alexandria

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.

Study Timeline

• Study Start: 2017-01-01
• Primary Completion: 2017-12-31
• Study Completion: 2018-12-31
• Status Verified: 2019-06
• Study First Submitted: 2019-06-02
• Study First Submitted QC: 2019-06-03
• Last Update Submitted: 2019-06-03
• Study First Posted: 2019-06-05
• Last Update Posted: 2019-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Persistent Diabetic macular edema	Sub-macular injection of Ranibizumab	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.

Primary Outcome Measures

Name	Time	Method
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