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

University of Alexandria19 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetic Macular Edema

Interventions

Sub-macular injection of RanibizumabPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

The primary endpoint for this study was the change in CMT at the final visit.

Central macular thickness

Time frame: at the 6 month follow up visit

Data from ClinicalTrials.gov

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