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

October 1, 2018 updated by: Allen C. Ho, MD, Wills Eye

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Mid Atlantic Retina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean central macular thickness (CMT) on SD-OCT at 1 month, 3 months, and 6 months after intravitreal injection of dexamethasone implant
Time Frame: Change in mean macular thickness baseline at 6 months
Change in mean macular thickness baseline at 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Visual acuity
Time Frame: Change in visual acuity baseline at 6 months
Change in visual acuity baseline at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wills Eye

Collaborators

Mid Atlantic Retina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 28, 2016

Primary Completion (ACTUAL)

September 14, 2017

Study Completion (ACTUAL)

September 14, 2017

Study Registration Dates

First Submitted

September 14, 2016

First Submitted That Met QC Criteria

December 13, 2016

First Posted (ESTIMATE)

December 16, 2016

Study Record Updates

Last Update Posted (ACTUAL)

October 3, 2018

Last Update Submitted That Met QC Criteria

October 1, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-475

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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