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Dexamethasone Intravitreal Implant After Vitrectomy For Epiretinal Membrane (OZURDEX2)

Primary Purpose

Epiretinal Membrane, Macular Edema

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dexamethasone Intravitreal Implant
Sponsored by
Barnes Retina Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epiretinal Membrane focused on measuring Epiretinal Membrane, Macular Edema, Dexamethasone Intravitreal Implant (Ozurdex), Pars Plana Vitrectomy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Lukes Hospital
  • St. Louis Eye Surgery and Laser Center
  • The Retina Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PPV + MP + DEX

PPV + MP

Arm Description

Patients will undergo pars plana vitrectomy, membrane peel, and concomitant Ozurdex implant (0.7 mg dose).

Patients will undergo pars plana vitrectomy with membrane peel, without Ozurdex implant.

Outcomes

Primary Outcome Measures

Changes in best corrected visual acuity
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.

Secondary Outcome Measures

Incidence of persistent macular edema on Central OCT thickness in treatment (PPV + MP + DEX) versus non-treatment (PPV + MP) groups
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

Full Information

First Posted
July 19, 2011
Last Updated
July 26, 2016
Sponsor
Barnes Retina Institute
Collaborators
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT01410201
Brief Title
Dexamethasone Intravitreal Implant After Vitrectomy For Epiretinal Membrane
Acronym
OZURDEX2
Official Title
Dexamethasone Intravitreal Implant After Vitrectomy for Idiopathic Epiretinal Membrane
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Terminated
Why Stopped
recruitment not met
Study Start Date
August 2011 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Barnes Retina Institute
Collaborators
Allergan

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epiretinal Membrane, Macular Edema
Keywords
Epiretinal Membrane, Macular Edema, Dexamethasone Intravitreal Implant (Ozurdex), Pars Plana Vitrectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PPV + MP + DEX
Arm Type
Experimental
Arm Description
Patients will undergo pars plana vitrectomy, membrane peel, and concomitant Ozurdex implant (0.7 mg dose).
Arm Title
PPV + MP
Arm Type
Active Comparator
Arm Description
Patients will undergo pars plana vitrectomy with membrane peel, without Ozurdex implant.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone Intravitreal Implant
Other Intervention Name(s)
Pars Plana Vitrectomy, Membrane Peel, Dexamethasone Intravitreal Implant (Ozurdex)
Intervention Description
Half of the study participants (15 out of 30) will receive one - Dexamethasone Intravitreal Implant 0.7 mg.
Primary Outcome Measure Information:
Title
Changes in best corrected visual acuity
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Incidence of persistent macular edema on Central OCT thickness in treatment (PPV + MP + DEX) versus non-treatment (PPV + MP) groups
Description
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
Time Frame
6 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gaurav K Shah, MD
Organizational Affiliation
Retina Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Lukes Hospital
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
St. Louis Eye Surgery and Laser Center
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
The Retina Institute
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63144
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
2089546
Citation
Smiddy WE, Michels RG, Green WR. Morphology, pathology, and surgery of idiopathic vitreoretinal macular disorders. A review. Retina. 1990;10(4):288-96. doi: 10.1097/00006982-199010000-00012.
Results Reference
background
PubMed Identifier
3179258
Citation
de Bustros S, Thompson JT, Michels RG, Rice TA, Glaser BM. Vitrectomy for idiopathic epiretinal membranes causing macular pucker. Br J Ophthalmol. 1988 Sep;72(9):692-5. doi: 10.1136/bjo.72.9.692.
Results Reference
background
PubMed Identifier
6514308
Citation
Michels RG. Vitrectomy for macular pucker. Ophthalmology. 1984 Nov;91(11):1384-8. doi: 10.1016/s0161-6420(84)34136-7.
Results Reference
background
PubMed Identifier
3763143
Citation
McDonald HR, Verre WP, Aaberg TM. Surgical management of idiopathic epiretinal membranes. Ophthalmology. 1986 Jul;93(7):978-83. doi: 10.1016/s0161-6420(86)33635-2.
Results Reference
background
PubMed Identifier
18536602
Citation
Schadlu R, Tehrani S, Shah GK, Prasad AG. Long-term follow-up results of ilm peeling during vitrectomy surgery for premacular fibrosis. Retina. 2008 Jun;28(6):853-7. doi: 10.1097/IAE.0b013e3181631962.
Results Reference
background
PubMed Identifier
10896363
Citation
Koerner F, Garweg J. Vitrectomy for macular pucker and vitreomacular traction syndrome. Doc Ophthalmol. 1999;97(3-4):449-58. doi: 10.1023/a:1002412323399.
Results Reference
background
PubMed Identifier
11124291
Citation
Massin P, Allouch C, Haouchine B, Metge F, Paques M, Tangui L, Erginay A, Gaudric A. Optical coherence tomography of idiopathic macular epiretinal membranes before and after surgery. Am J Ophthalmol. 2000 Dec;130(6):732-9. doi: 10.1016/s0002-9394(00)00574-2.
Results Reference
background
PubMed Identifier
19734764
Citation
Konstantinidis L, Berguiga M, Beknazar E, Wolfensberger TJ. Anatomic and functional outcome after 23-gauge vitrectomy, peeling, and intravitreal triamcinolone for idiopathic macular epiretinal membrane. Retina. 2009 Sep;29(8):1119-27. doi: 10.1097/IAE.0b013e3181ac23da.
Results Reference
background
PubMed Identifier
16531422
Citation
Kosobucki BR, Freeman WR, Cheng L. Photographic estimation of the duration of high dose intravitreal triamcinolone in the vitrectomised eye. Br J Ophthalmol. 2006 Jun;90(6):705-8. doi: 10.1136/bjo.2005.088278. Epub 2006 Mar 10.
Results Reference
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Dexamethasone Intravitreal Implant After Vitrectomy For Epiretinal Membrane

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