NCT02995746

Intravitreal Dexamethasone Implant for Persistent Macular Thickening and Edema After Vitrectomy for Epiretinal Membrane

Intravitreal Dexamethasone Implant for Persistent Macular Thickening and Edema After Vitrectomy for Epiretinal Membrane: A Pilot Study

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Wills Eye · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

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.

Detailed description

Macular edema is a relatively common occurrence after pars plana vitrectomy. Kim et al described that 47% of eyes undergoing vitrectomy for epiretinal membrane, macular hole, or vitreous hemorrhage had evidence of macular thickening on optical coherence tomography scan.1 Post-vitrectomy macular edema can limit potential visual acuity gain from removal of a symptomatic epiretinal membrane. Typical treatment of post-operative macular edema consists of topical non-steroidal anti-inflammatory drugs (NSAIDs) and topical corticosteroids; however, there are still resistant cases with refractory macular thickening. The dexamethasone intravitreal implant (Ozurdex; Allergan, Irvine, CA) is currently FDA-approved for the treatment of posterior uveitis as well as macular edema secondary to retinal vein occlusion and diabetic retinopathy. Furino et al reported a retrospective series describing how a single injection of the 0.7mg dexamethasone intravitreal implant resulted in a substantial increase in best-corrected visual acuity (BCVA) and a decrease in central macular thickness (CMT) on spectral-domain optical coherence tomography (SD-OCT) in 8 patients with persistent macular thickening after pars plana vitrectomy for epiretinal membrane. There has been no prospective study evaluating the efficacy of this pharmacologic agent in this setting. As such, the purpose of this study is to prospectively evaluate the effect of the intravitreal 0.7mg dexamethasone implant on CMT and BCVA in those patients with persistent macular edema after pars plana vitrectomy for epiretinal membrane. The results of this study will help delineate whether the intravitreal dexamethasone implant has efficacy in improving CMT and/or visual acuity in those patients with refractory macular thickening after pars plana vitrectomy for epiretinal membrane.

Conditions

• Macular Edema
• Epiretinal Membrane
• Vitrectomy

Interventions

Type	Name	Description
DRUG	Dexamethasone	* On study visit #1 all patients will have a SD-OCT scan and measurement of baseline visual acuity. All patients will receive the 0.7mg dexamethasone intravitreal implant * Subsequent follow-up visits will be at 1 month, 2 months, 3 months, 4 months, 5 months, and 6 months after intravitreal injection of dexamethasone implant * Each visit will consist of measurement of visual acuity, intraocular pressure, dilated fundoscopic examination, and SD-OCT scan * Anticipated duration of the study: 6 months

Timeline

• Start date: 2016-01-28
• Primary completion: 2017-09-14
• Completion: 2017-09-14
• First posted: 2016-12-16
• Last updated: 2018-10-03

Locations

1 site across 1 country: United States