Intravitreal Dexamethasone Implant for Persistent Macular Thickening and Edema After Vitrectomy f… (NCT02995746) | Clinical Trial Compass
TerminatedNot Applicable
Intravitreal Dexamethasone Implant for Persistent Macular Thickening and Edema After Vitrectomy for Epiretinal Membrane
Stopped: Terminated due to lack of drug efficacy. 2017 study did not show benefit.
United States3 participantsStarted 2016-01-28
Plain-language summary
This study seeks to evaluate the effect of the intravitreal 0.7mg dexamethasone implant on central macular thickness and visual acuity in those patients with persistent macular edema after pars plana vitrectomy for epiretinal membrane.
Who can participate
Age range18 Years – 90 Years
SexALL
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Inclusion criteria
✓. Patient of the Wills Eye Institute Retina service, including all Mid-Atlantic Retina offices
✓. Volunteer patients age 18 years and older
✓. Healthy enough to participate in the study
✓. Willing and able to consent to participation in the study
✓. History of pars plan vitrectomy for symptomatic epiretinal membrane at least 3 months prior to study enrollment date
✓. BCVA of 20/40 or worse
✓. CMT of at least 400 micrometers with or without cystoid macular edema on SD-OCT
✓. Prior treatment with topical NSAIDs without resolution of macular thickening or visual acuity improvement
Exclusion criteria
✕. Advanced glaucoma (cup-disc ratio of 0.8 or greater)
✕. History of glaucoma filtering or tube shunt implant surgery
✕. Steroid responsive intraocular hypertension
✕. Diabetic retinopathy
✕. History of uveitis
✕. Use of systemic or intraocular corticosteroids
What they're measuring
1
Mean central macular thickness (CMT) on SD-OCT at 1 month, 3 months, and 6 months after intravitreal injection of dexamethasone implant
Timeframe: Change in mean macular thickness baseline at 6 months