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

• Sponsor: Wills Eye (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02995746
• Collaborator: Mid Atlantic Retina (Other)
• Enrollment: 3
• Location: 1
• Arm: 1
• Actual Duration (Months): 19.5
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Macular Edema; Epiretinal Membrane; Vitrectomy	Drug: Dexamethasone	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 3 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Intravitreal Dexamethasone Implant for Persistent Macular Thickening and Edema After Vitrectomy for Epiretinal Membrane: A Pilot Study
• Actual Study Start Date: Jan 28, 2016
• Actual Primary Completion Date: Sep 14, 2017
• Actual Study Completion Date: Sep 14, 2017

Arms and Interventions

Arm

Intervention/Treatment

Experimental: 0.7mg dexamethasone intravitreal implant Single intravitreal implantation of 0.7mg dexamethasone with a six month follow up period

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; Other Names: Ozurdex

Outcome Measures

Primary Outcome Measures

1. Mean central macular thickness (CMT) on SD-OCT at 1 month, 3 months, and 6 months after intravitreal injection of dexamethasone implant [Change in mean macular thickness baseline at 6 months]

Secondary Outcome Measures

1. Visual acuity [Change in visual acuity baseline at 6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Patient of the Wills Eye Institute Retina service, including all Mid-Atlantic Retina offices

2. Volunteer patients age 18 years and older

3. Healthy enough to participate in the study

4. Willing and able to consent to participation in the study

5. History of pars plan vitrectomy for symptomatic epiretinal membrane at least 3 months prior to study enrollment date

6. BCVA of 20/40 or worse

7. CMT of at least 400 micrometers with or without cystoid macular edema on SD-OCT

8. Prior treatment with topical NSAIDs without resolution of macular thickening or visual acuity improvement

Exclusion Criteria:

1. Advanced glaucoma (cup-disc ratio of 0.8 or greater)

2. History of glaucoma filtering or tube shunt implant surgery

3. Steroid responsive intraocular hypertension

4. Diabetic retinopathy

5. History of uveitis

6. Use of systemic or intraocular corticosteroids

7. Active or suspected ocular or periocular infections

8. Other confounding intraocular pathology

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mid Atlantic Retina	Philadelphia	Pennsylvania	United States	19107

Sponsors and Collaborators

• Wills Eye
• Mid Atlantic Retina

Investigators

• Principal Investigator: Allen C Ho, MD, Mid Atlantic Retina

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Allen C. Ho, MD, MD, Wills Eye
• ClinicalTrials.gov Identifier: NCT02995746
• Other Study ID Numbers: 15-475
• First Posted: Dec 16, 2016
• Last Update Posted: Oct 3, 2018
• Last Verified: Oct 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Macular Edema; Epiretinal Membrane; Edema; Dexamethasone

Study Results

No Results Posted as of Oct 3, 2018