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

Diabetic Macular Edema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03975088
• Other study ID #: 31185
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: June 2019
• Source: University of Alexandria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Alexandria

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint for this study was the change in CMT at the final visit.	Central macular thickness	at the 6 month follow up visit