UnknownNot Applicable

Vitrectomy With Planned Foveal Detachment for Refractory DME With or Without Vitreo-macular Interface Abnormality

28 participantsStarted 2015-11

Plain-language 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, intravitreal corticosteroids and to previous vitrectomy. Some of enrolled cases had normal vitreo-macular interface (VMI) relationship, while other cases had incomplete vitreoretinal separation with vitreomacular attachment (VMA).

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * 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 Criteria: * 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.

What they're measuring

central macular thickness decrease

Timeframe: 10 months postperative

Trial details

NCT IDNCT03345056

SponsorMinistry of Health and Population, Egypt

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2017-11

View on ClinicalTrials.gov More Chronic Edema of the Macula trials