Dexamethasone Intravitreal Implant After Vitrectomy For Epiretinal Membrane (OZURDEX2)

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ClinicalTrials.gov Identifier: NCT01410201

Recruitment Status : Terminated (recruitment not met)

First Posted : August 5, 2011

Last Update Posted : July 27, 2016

Sponsor:

Collaborator:

Allergan

Information provided by (Responsible Party):

Rhonda Weeks, Barnes Retina Institute

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).

Condition or disease	Intervention/treatment	Phase
Epiretinal Membrane Macular Edema	Drug: Dexamethasone Intravitreal Implant	Not Applicable

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 Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	6 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Dexamethasone Intravitreal Implant After Vitrectomy for Idiopathic Epiretinal Membrane
Study Start Date :	August 2011
Actual Primary Completion Date :	January 2016
Actual Study Completion Date :	January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Drug Information available for: Dexamethasone Dexamethasone sodium phosphate Dexamethasone acetate

U.S. FDA Resources

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures :

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.

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 ]
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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01410201

Locations


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

Sponsors and Collaborators

Barnes Retina Institute

Allergan

Investigators


Principal Investigator:	Gaurav K Shah, MD	Retina Institute

More Information

Publications:

Smiddy WE, Michels RG, Green WR. Morphology, pathology, and surgery of idiopathic vitreoretinal macular disorders. A review. Retina. 1990;10(4):288-96. Review.

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.

Michels RG. Vitrectomy for macular pucker. Ophthalmology. 1984 Nov;91(11):1384-8.

McDonald HR, Verre WP, Aaberg TM. Surgical management of idiopathic epiretinal membranes. Ophthalmology. 1986 Jul;93(7):978-83.

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.

Koerner F, Garweg J. Vitrectomy for macular pucker and vitreomacular traction syndrome. Doc Ophthalmol. 1999;97(3-4):449-58.

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.

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.

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. Epub 2006 Mar 10.


Responsible Party:	Rhonda Weeks, Gaurav K. Shah, MD, Barnes Retina Institute
ClinicalTrials.gov Identifier:	NCT01410201 History of Changes
Other Study ID Numbers:	OZURDEX ERM
First Posted:	August 5, 2011 Key Record Dates
Last Update Posted:	July 27, 2016
Last Verified:	July 2016

Keywords provided by Rhonda Weeks, Barnes Retina Institute:


Epiretinal Membrane Macular Edema Dexamethasone Intravitreal Implant (Ozurdex) Pars Plana Vitrectomy

Additional relevant MeSH terms:


Macular Edema Epiretinal Membrane Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases Dexamethasone acetate Dexamethasone BB 1101 Temazepam Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs	Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Hypnotics and Sedatives Central Nervous System Depressants Anti-Anxiety Agents Tranquilizing Agents Psychotropic Drugs GABA Modulators

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