Dexamethasone Intravitreal Implant After Vitrectomy For Epiretinal Membrane (OZURDEX2)

July 26, 2016 updated by: Rhonda Weeks, Barnes Retina Institute

Dexamethasone Intravitreal Implant After Vitrectomy for Idiopathic Epiretinal Membrane

The purpose of this study is to evaluate the effect of dexamethasone intravitreal implant (Ozurdex) in combination with pars plana vitrectomy and membrane peeling for idiopathic epiretinal membrane (ERM).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Pars plana vitrectomy with membrane peeling has been used for years to successfully to treat ERM (epiretinal membrane). However, despite successful surgery, approximately 10-30% of patients may not experience any improvement in visual acuity (ref. 1-7). Macular causes of unsatisfactory visual outcome following vitrectomy include persistent macular edema and reoccurrence of epiretinal membrane (ref. 1-7). Concomitant administration of intravitreal corticosteroids (triamcinolone acetonide) after pars plana vitrectomy and membrane peeling for epiretinal membrane has been reported to speed up and improve the anatomic and functional outcome (ref 8). Given that intravitreal triamcinolone has been reported to last approximately 113 days ina post-vitrectomy eye (ref. 9); the investigators postulate that a longer-acting corticosteroid such as Ozurdex could not only have the benefits of improved anatomic and functional outcomes, but also a longer sustained effect.

Study Type

Interventional

Enrollment (Actual)

6

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
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • St. Lukes Hospital
      • St. Louis, Missouri, United States, 63131
        • St. Louis Eye Surgery and Laser Center
      • St. Louis, Missouri, United States, 63144
        • The Retina Institute

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with idiopathic epiretinal membrane
  • Preoperative visual acuity of snellen equivalent 20/32 or worse

Exclusion Criteria:

  • History or presence of any of the following:
  • uveitis
  • macular hole
  • previous vitreoretinal surgery
  • any other retinal pathology that could affect anatomic or functional results
  • Age Related Macular Degeneration
  • Diabetic Retinopathy
  • Diabetic Macular Edema
  • Retinal Vein Occlusion
  • Pre-existing Macular Disease

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: PPV + MP + DEX
Patients will undergo pars plana vitrectomy, membrane peel, and concomitant Ozurdex implant (0.7 mg dose).
Drug: Dexamethasone Intravitreal Implant
Half of the study participants (15 out of 30) will receive one - Dexamethasone Intravitreal Implant 0.7 mg.
Other Names:
  • Pars Plana Vitrectomy
  • Membrane Peel
  • Dexamethasone Intravitreal Implant (Ozurdex)
ACTIVE_COMPARATOR: PPV + MP
Patients will undergo pars plana vitrectomy with membrane peel, without Ozurdex implant.
Drug: Dexamethasone Intravitreal Implant
Half of the study participants (15 out of 30) will receive one - Dexamethasone Intravitreal Implant 0.7 mg.
Other Names:
  • Pars Plana Vitrectomy
  • Membrane Peel
  • Dexamethasone Intravitreal Implant (Ozurdex)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in best corrected visual acuity
Time Frame: 6 months

At all study visits:

ETDRS visual acuity will be measured visit excluding post op day 1 (snellen visual acuity will be measured).

Intraocular pressure (IOP) will be checked. Spectral Domain Optical Coherence Tomography (OCT). Dilated fundus exam.

At Pre Op, Post Op Week 4, 8, 12, 16, 20 and 24 visits:

ETDRS visual acuity will be measured. IOP check. Spectral Domain OCT. Fundus photography. Fundus Autofluorescence (AF). Fluorescein Angiography (FA). Dilated Fundus exam.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of persistent macular edema on Central OCT thickness in treatment (PPV + MP + DEX) versus non-treatment (PPV + MP) groups
Time Frame: 6 months

At all visits: ETDRS visual acuity will be measured except post op day 1 (snellen visual acuity will be measured) Intraocular pressure (IOP) will be checked Spectral Domain Optical Coherence Tomography (OCT) Dilated fundus exam

At Pre Op, Post Op Week 4, 8, 12, 16, 20, and 24:

ETDRS visual acuity will be measured IOP will be checked Spectral Domain OCT Fundus Photography Fundus Auto Fluorescence (AF) Fluorescein Angiography (FA) Dilated Fundus exam
6 months

Collaborators and Investigators

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

Sponsor

Barnes Retina Institute

Collaborators

Allergan

Investigators

  • Principal Investigator: Gaurav K Shah, MD, Retina Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

August 1, 2011

Primary Completion (ACTUAL)

January 1, 2016

Study Completion (ACTUAL)

January 1, 2016

Study Registration Dates

First Submitted

July 19, 2011

First Submitted That Met QC Criteria

August 4, 2011

First Posted (ESTIMATE)

August 5, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

July 27, 2016

Last Update Submitted That Met QC Criteria

July 26, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OZURDEX ERM

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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