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

University of Alexandria

Status: Completed

Conditions: Diabetic Macular Edema

Treatments: Procedure: Sub-macular injection of Ranibizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT03975088

31185 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

Persistent Diabetic macular edema

Other group

Description:

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.

Treatment:

Procedure: Sub-macular injection of Ranibizumab