Study Stopped
recruitment not met
Dexamethasone Intravitreal Implant After Vitrectomy For Epiretinal Membrane
OZURDEX2
1 other identifier
interventional
6
1 country
3
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2011
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 19, 2011
CompletedStudy Start
First participant enrolled
August 1, 2011
CompletedFirst Posted
Study publicly available on registry
August 5, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedJuly 27, 2016
July 1, 2016
4.4 years
July 19, 2011
July 26, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
6 months
Secondary Outcomes (1)
Incidence of persistent macular edema on Central OCT thickness in treatment (PPV + MP + DEX) versus non-treatment (PPV + MP) groups
6 months
Study Arms (2)
PPV + MP + DEX
EXPERIMENTALPatients will undergo pars plana vitrectomy, membrane peel, and concomitant Ozurdex implant (0.7 mg dose).
PPV + MP
ACTIVE COMPARATORPatients will undergo pars plana vitrectomy with membrane peel, without Ozurdex implant.
Interventions
Half of the study participants (15 out of 30) will receive one - Dexamethasone Intravitreal Implant 0.7 mg.
Eligibility Criteria
You may qualify if:
- Patients with idiopathic epiretinal membrane
- Preoperative visual acuity of snellen equivalent 20/32 or worse
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Barnes Retina Institutelead
- Allergancollaborator
Study Sites (3)
St. Lukes Hospital
Chesterfield, Missouri, 63017, United States
St. Louis Eye Surgery and Laser Center
St Louis, Missouri, 63131, United States
The Retina Institute
St Louis, Missouri, 63144, United States
Related Publications (9)
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.
PMID: 2089546BACKGROUNDde 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.
PMID: 3179258BACKGROUNDMichels RG. Vitrectomy for macular pucker. Ophthalmology. 1984 Nov;91(11):1384-8. doi: 10.1016/s0161-6420(84)34136-7.
PMID: 6514308BACKGROUNDMcDonald 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.
PMID: 3763143BACKGROUNDSchadlu 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.
PMID: 18536602BACKGROUNDKoerner F, Garweg J. Vitrectomy for macular pucker and vitreomacular traction syndrome. Doc Ophthalmol. 1999;97(3-4):449-58. doi: 10.1023/a:1002412323399.
PMID: 10896363BACKGROUNDMassin 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.
PMID: 11124291BACKGROUNDKonstantinidis 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.
PMID: 19734764BACKGROUNDKosobucki 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.
PMID: 16531422BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gaurav K Shah, MD
Retina Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Gaurav K. Shah, MD
Study Record Dates
First Submitted
July 19, 2011
First Posted
August 5, 2011
Study Start
August 1, 2011
Primary Completion
January 1, 2016
Study Completion
January 1, 2016
Last Updated
July 27, 2016
Record last verified: 2016-07