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Epiretinal MembraneOZURDEX2NCT01410201

Dexamethasone Intravitreal Implant After Vitrectomy For Epiretinal Membrane

A study testing Dexamethasone Intravitreal Implant in people with Epiretinal Membrane and Macular Edema, run by Barnes Retina Institute at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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). Read more about this study

Who is it for?
Any age
Conditions the study is for
Epiretinal Membrane, Macular Edema
What is being tested?
Dexamethasone Intravitreal Implant
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
3 sitesUnited States
Study dates
Aug 2011to Jan 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Patients with idiopathic epiretinal membrane
  • Preoperative visual acuity of snellen equivalent 20/32 or worse

Who cannot join

  • 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
Show all 10Show fewer
  • Diabetic Retinopathy
  • Diabetic Macular Edema
  • Retinal Vein Occlusion
  • Pre-existing Macular Disease

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • St. Lukes Hospital

    Chesterfield, Missouri, 63017

  • St. Louis Eye Surgery and Laser Center

    St Louis, Missouri, 63131

  • The Retina Institute

    St Louis, Missouri, 63144

Other trials in United States

About this study

Official title: Dexamethasone Intravitreal Implant After Vitrectomy for Idiopathic Epiretinal Membrane

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).

Read the 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.

Being tested
Dexamethasone Intravitreal Implant
Keywords
Epiretinal Membrane, Macular Edema, Dexamethasone Intravitreal Implant (Ozurdex), Pars Plana Vitrectomy
Medical subject headings
Epiretinal Membrane, Macular Edema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dexamethasone Intravitreal ImplantDrug

    Also called Pars Plana Vitrectomy, Membrane Peel, Dexamethasone Intravitreal Implant (Ozurdex)

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

Study groups in NCT01410201
Study groupRoleWhat they receive
PPV + MP + DEXExperimentalPatients will undergo pars plana vitrectomy, membrane peel, and concomitant Ozurdex implant (0.7 mg dose).
Receives: Drug: Dexamethasone Intravitreal Implant
PPV + MPActive comparatorPatients will undergo pars plana vitrectomy with membrane peel, without Ozurdex implant.
Receives: Drug: Dexamethasone Intravitreal Implant

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 months

Secondary outcomes (1)

  1. 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

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2011 (estimated)
  2. Study startAug 2011
  3. Primary completionJan 2016
  4. Study completionJan 2016

Why it stopped: recruitment not met

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01410201
Sponsor's protocol ID
OZURDEX ERM
Acronym
OZURDEX2
Status last verified
Jul 2016
First submitted
19 Jul 2011
Last updated
27 Jul 2016
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 2089546

  • 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.

    PubMed 3179258

  • Michels RG. Vitrectomy for macular pucker. Ophthalmology. 1984 Nov;91(11):1384-8. doi: 10.1016/s0161-6420(84)34136-7.

    PubMed 6514308

  • 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.

    PubMed 3763143

  • 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.

    PubMed 18536602

  • 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.

    PubMed 10896363

  • 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.

    PubMed 11124291

  • 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.

    PubMed 19734764

  • 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.

    PubMed 16531422

Questions about this trial

What is this clinical trial studying?

A study testing Dexamethasone Intravitreal Implant in people with Epiretinal Membrane and Macular Edema, run by Barnes Retina Institute at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: recruitment not met). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in best corrected visual acuity (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01410201, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2016.

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