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Dexamethasone Intravitreal Implant After Vitrectomy For Epiretinal Membrane (OZURDEX2)

This study is currently recruiting participants.
Verified February 2013 by Barnes Retina Institute
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Rhonda Weeks, Barnes Retina Institute
ClinicalTrials.gov Identifier:
NCT01410201
First received: July 19, 2011
Last updated: February 5, 2013
Last verified: February 2013
History of Changes
  Purpose

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).


Condition Intervention
Epiretinal Membrane
Macular Edema
 Drug: Dexamethasone Intravtireal Implant

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Dexamethasone Intravitreal Implant After Vitrectomy for Idiopathic Epiretinal Membrane

Resource links provided by NLM:

MedlinePlus related topics: Edema
U.S. FDA Resources

Further study details as provided by Barnes Retina Institute:

Primary Outcome Measures:
  • Changes in best corrected visual acuity [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    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



Estimated Enrollment: 30
Study Start Date: August 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PPV + MP + DEX
Patients will undergo pars plana vitrectomy, membrane peel, and concomitant Ozurdex implant (0.7 mg dose).
 Drug: Dexamethasone Intravtireal 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 Intravtireal 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)

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01410201

Contacts
Contact: Rhonda Weeks, CCRC 314-367-1181 ext 2240 rweeks@rc-stl.com
Contact: Ginny Nobel, COT 314-367-1181 ext 2305 vnobel@rc-stl.com

Locations
United States, Missouri
St. Lukes Hospital Recruiting
Chesterfield, Missouri, United States, 63017
Contact: Rhonda Weeks, CCRC     314-367-1181 ext 2240     rweeks@rc-stl.com    
Contact: Ginny Nobel, COT     314-367-1181 ext 2305     vnobel@rc-stl.com    
Principal Investigator: Gaurav K Shah, MD            
Sub-Investigator: Kevin J Blinder, MD            
Sub-Investigator: Matthew Thomas, MD            
Barnes Jewish Hospital Recruiting
St. Louis, Missouri, United States, 63108
Contact: Rhonda Weeks, CCRC     314-367-1181 ext 2240     rweeks@rc-stl.com    
Contact: Ginny Nobel, COT     314-367-1278 ext 2305     vnobel@rc-stl.com    
Principal Investigator: Gaurav K Shah, MD            
Sub-Investigator: Kevin J Blinder, MD            
Sub-Investigator: Matthew Thomas, MD            
St. Louis Eye Surgery and Laser Center Recruiting
St. Louis, Missouri, United States, 63131
Contact: Rhonda Weeks, CCRC     314-367-1181 ext 2240     rweeks@rc-stl.com    
Contact: Ginny Nobel     314-367-1181 ext 2305     vnobel@rc-stl.com    
Principal Investigator: Gaurav K Shah, MD            
Sub-Investigator: Kevin J Blinder, MD            
Sponsors and Collaborators
Barnes Retina Institute
Allergan
Investigators
Principal Investigator: Gaurav K Shah, MD Retina Institute
  More Information

Publications:

Responsible Party: Rhonda Weeks, Gaurav K. Shah, MD, Barnes Retina Institute
ClinicalTrials.gov Identifier: NCT01410201     History of Changes
Other Study ID Numbers: OZURDEX ERM
Study First Received: July 19, 2011
Last Updated: February 5, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Barnes Retina Institute:
Epiretinal Membrane
Macular Edema
Dexamethasone Intravitreal Implant (Ozurdex)
Pars Plana Vitrectomy

Additional relevant MeSH terms:
Edema
Macular Edema
Epiretinal Membrane
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
 Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013