Status:
UNKNOWN
Vitrectomy With Planned Foveal Detachment for Refractory DME With or Without Vitreo-macular Interface Abnormality
Lead Sponsor:
Ministry of Health and Population, Egypt
Conditions:
Chronic Edema of the Macula
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To evaluate the therapeutic efficacy of sub retinal BSS injections in conjunction with conventional vitrectomy for refractory Diabetic macular edema (DME)- resistant to more than one anti-VEGF agent, ...
Eligibility Criteria
Inclusion
- Cases with refractory DME with a central macular thickness (CMT) of more than 300 µm despite undergoing anti-VEGF therapy (5-6 monthly injections of ranibizumab (IVR) or bevacizumab (IVB) with shifting to aflibercept (IVA) for additional 3 injections).
Exclusion
- The major exclusion criteria were: (1) presence of apparent retinal pigment epithelium (RPE) atrophy at or near the macula; (2) presence of proliferative diabetic fibrovascular membranes threating or at the macula; (3) presence of diabetic optic atrophy; and (4) presence of neovascular glaucoma.
Key Trial Info
Start Date :
November 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2017
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT03345056
Start Date
November 1 2015
End Date
November 1 2017
Last Update
November 17 2017
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