Dexamethasone Intravitreal Implant After Vitrectomy For Epiretinal Membrane

Macular Edema Clinical Trial

— OZURDEX2  

Official title:

Dexamethasone Intravitreal Implant After Vitrectomy for Idiopathic Epiretinal Membrane

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01410201
• Other study ID #: OZURDEX ERM
• Status: Terminated
• Phase: N/A
• First received: July 19, 2011
• Last updated: July 26, 2016
• Start date: August 2011
• Est. completion date: January 2016

Study information

• Verified date: July 2016
• Source: Barnes Retina Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epiretinal Membrane
• Macular Edema

Intervention

Drug:
• Dexamethasone Intravitreal Implant
Half of the study participants (15 out of 30) will receive one - Dexamethasone Intravitreal Implant 0.7 mg.

Locations

Country	Name	City	State
United States	St. Lukes Hospital	Chesterfield	Missouri
United States	St. Louis Eye Surgery and Laser Center	St. Louis	Missouri
United States	The Retina Institute	St. Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Barnes Retina Institute	Allergan

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View Citation

Koerner F, Garweg J. Vitrectomy for macular pucker and vitreomacular traction syndrome. Doc Ophthalmol. 1999;97(3-4):449-58. — View 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. — View 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. Epub 2006 Mar 10. — View 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. — View Citation

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

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

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Incidence of persistent macular edema on Central OCT thickness in treatment (PPV + MP + DEX) versus non-treatment (PPV + MP) groups	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	6 months	No