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

NCT03975088 | Completed

• 1 other identifier: 31185
• Study Type: interventional
• Target: 19
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Persistent Diabetic macular edema

OTHER

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

Interventions

Sub-macular injection of Ranibizumab PROCEDURE

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.

Persistent Diabetic macular edema

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alexandria: lead

Related Publications (1)

• El-Baha SM, Abdel Hadi AM, Abouhussein MA. Submacular Injection of Ranibizumab as a New Surgical Treatment for Refractory Diabetic Macular Edema. J Ophthalmol. 2019 Oct 21;2019:6274209. doi: 10.1155/2019/6274209. eCollection 2019.

  PMID: 31772766 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: June 2, 2019
• First Posted: June 5, 2019
• Study Start: January 1, 2017
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2018
• Last Updated: June 5, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share