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

Arm | Intervention/treatment |
---|---|
Experimental: PPV + MP + DEX
Patients will undergo pars plana vitrectomy, membrane peel, and concomitant Ozurdex implant (0.7 mg dose).
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Drug: Dexamethasone Intravitreal Implant
Half of the study participants (15 out of 30) will receive one - Dexamethasone Intravitreal Implant 0.7 mg.
Other Names:
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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:
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- 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.
- 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

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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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