Dexamethasone Intravitreal Implant After Vitrectomy For Epiretinal Membrane
Information source: Barnes Retina Institute
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Epiretinal Membrane; Macular Edema
Intervention: Dexamethasone Intravtireal Implant (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Barnes Retina Institute Official(s) and/or principal investigator(s): Gaurav K Shah, MD, Principal Investigator, Affiliation: Retina Institute
Overall contact: Rhonda Weeks, CCRC, Phone: 314-367-1181, Ext: 2609, Email: rhonda.weeks@rc-stl.com
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).
Clinical Details
Official title: Dexamethasone Intravitreal Implant After Vitrectomy for Idiopathic Epiretinal Membrane
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Changes in best corrected visual acuity
Secondary outcome: Incidence of persistent macular edema on Central OCT thickness in treatment (PPV + MP + DEX) versus non-treatment (PPV + MP) groups
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
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Rhonda Weeks, CCRC, Phone: 314-367-1181, Ext: 2609, Email: rhonda.weeks@rc-stl.com
St. Lukes Hospital, Chesterfield, Missouri 63017, United States; Recruiting Rhonda Weeks, CCRC, Phone: 314-367-1181, Ext: 2609, Email: rhonda.weeks@rc-stl.com Ginny Nobel, COT, Phone: 314-367-1181, Ext: 2617, Email: ginny.nobel@rc-stl.com Gaurav K Shah, MD, Principal Investigator Kevin J Blinder, MD, Sub-Investigator Matthew A Thomas, MD, Sub-Investigator Bradley T Smith, MD, Sub-Investigator
St. Louis Eye Surgery and Laser Center, St. Louis, Missouri 63131, United States; Recruiting Rhonda Weeks, CCRC, Phone: 314-367-1181, Ext: 2609, Email: rhonda.weeks@rc-stl.com Ginny Nobel, Phone: 314-367-1181, Ext: 2617, Email: ginny.nobel@rc-stl.com Gaurav K Shah, MD, Principal Investigator Kevin J Blinder, MD, Sub-Investigator
The Retina Institute, St. Louis, Missouri 63144, United States; Recruiting Rhonda Weeks, CCRC, Phone: 314-367-1181, Ext: 2609, Email: rhonda.weeks@rc-stl.com Ginny Nobel, COT, Phone: 314-367-1181, Ext: 2617, Email: ginny.nobel@rc-stl.com Gaurav K Shah, MD, Principal Investigator Kevin J Blinder, MD, Sub-Investigator Matthew A Thomas, MD, Sub-Investigator Bradley T Smith, MD, Sub-Investigator
Additional Information
Related 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.
Starting date: August 2011
Last updated: July 24, 2015
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