Sub-macular Injection of Ranibizumab as a New Surgical Treatment for Refractory Diabetic Macular Edema
June 3, 2019 updated by: Mahmoud Abouhussein, University of Alexandria
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
19
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Persistent Diabetic macular edema
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The primary endpoint for this study was the change in CMT at the final visit.
Time Frame: at the 6 month follow up visit
|
Central macular thickness
|
at the 6 month follow up visit
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2017
Primary Completion (Actual)
December 31, 2017
Study Completion (Actual)
December 31, 2018
Study Registration Dates
First Submitted
June 2, 2019
First Submitted That Met QC Criteria
June 3, 2019
First Posted (Actual)
June 5, 2019
Study Record Updates
Last Update Posted (Actual)
June 5, 2019
Last Update Submitted That Met QC Criteria
June 3, 2019
Last Verified
June 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 31185 (Berlex Oncology ID)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
proecting patient privacy
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.