Clinical trial NCT01410201: Dexamethasone Intravitreal Implant After Vitrectomy For Epiretinal Membrane
Official title: Dexamethasone Intravitreal Implant After Vitrectomy for Idiopathic Epiretinal Membrane
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Epiretinal Membrane
Macular Edema
Keywords: Epiretinal Membrane
Macular Edema
Dexamethasone Intravitreal Implant (Ozurdex)
Pars Plana Vitrectomy
Lead sponsor: Barnes Retina Institute
Sponsor class: OTHER
Collaborators: name: Allergan
First posted: 2011-08-05
Enrollment: 6
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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 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

Primary outcomes:
measure: Changes in best corrected visual acuity
timeFrame: 6 months
Secondary outcomes:
measure: Incidence of persistent macular edema on Central OCT thickness in treatment (PPV + MP + DEX) versus non-treatment (PPV + MP) groups
timeFrame: 6 months
Other outcomes:
Locations:
city: Chesterfield
country: United States
facility: St. Lukes Hospital
state: Missouri
city: St. Louis
country: United States
facility: St. Louis Eye Surgery and Laser Center
state: Missouri
city: St. Louis
country: United States
facility: The Retina Institute
state: Missouri
Study officials:
affiliation: Retina Institute
name: Gaurav K Shah, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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. doi: 10.1136/bjo.72.9.692.
citation: Michels RG. Vitrectomy for macular pucker. Ophthalmology. 1984 Nov;91(11):1384-8. doi: 10.1016/s0161-6420(84)34136-7.
citation: McDonald 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.
citation: 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.
citation: Koerner F, Garweg J. Vitrectomy for macular pucker and vitreomacular traction syndrome. Doc Ophthalmol. 1999;97(3-4):449-58. doi: 10.1023/a:1002412323399.
citation: 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. doi: 10.1016/s0002-9394(00)00574-2.
citation: 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.
citation: 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. doi: 10.1136/bjo.2005.088278. Epub 2006 Mar 10.