NCT02412059

Brief Summary

In this prospective randomized controlled double blind pilot clinical study, we aim to assess whether administration of a topical corticosteroid would attenuate epiretinal membrane formation following development of retinal tears treated with laser retionpexy.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2015

Shorter than P25 for not_applicable

Status
completed

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

April 3, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 8, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

January 29, 2016

Status Verified

January 1, 2016

Enrollment Period

5 months

First QC Date

April 3, 2015

Last Update Submit

January 28, 2016

Conditions

Epiretinal Membrane

Outcome Measures

Primary Outcomes (1)

  • Incidence of epiretinal membrane

    6-months following administration of corticosteroid

Study Arms (2)

Prednisolone

EXPERIMENTAL

Pred Forte (prednisolone acetate ophthalmic suspension, USP) 1% sterile

Drug: Prednisolone acetate

Control

NO INTERVENTION

Patients in control group will not be given a corticosteroid as per usual standard of care.

Interventions

Prednisolone acetateDRUG
Also known as: Pred Forte
Prednisolone

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Between ages 18 to 80 (inclusive)
  • English-speaking
  • Undergoing non-pneumatic laser retinopexy procedure for horseshoe retinal tear (without retinal detachment)

You may not qualify if:

  • Patient refusal or delay of retinopexy procedure for more than 48 hours after diagnosis
  • Patients who are pseudophakic or aphakic
  • Medical conditions contraindicated with prednisolone: viral diseases of the cornea and conjunctiva including herpes simplex, vaccinia, varicella; fundal diseases of ocular structures; mycobacterial infections; hypercortisolism.
  • Previous history of epiretinal membrane, retinal surgery (cryo or laser)
  • Patients with hypersensitivity or contraindication for corticosteroids (viral diseases of the cornea and conjunctiva including herpes simplex, vaccinia, varicella; fungal diseases of ocular structures; mycobacterial infections; hypercortisolism).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • Bu SC, Kuijer R, Li XR, Hooymans JM, Los LI. Idiopathic epiretinal membrane. Retina. 2014 Dec;34(12):2317-35. doi: 10.1097/IAE.0000000000000349.

    PMID: 25360790BACKGROUND

  • Saran BR, Brucker AJ. Macular epiretinal membrane formation and treated retinal breaks. Am J Ophthalmol. 1995 Oct;120(4):480-5. doi: 10.1016/s0002-9394(14)72662-5.

    PMID: 7573306BACKGROUND

  • Snead DR, James S, Snead MP. Pathological changes in the vitreoretinal junction 1: epiretinal membrane formation. Eye (Lond). 2008 Oct;22(10):1310-7. doi: 10.1038/eye.2008.36. Epub 2008 Mar 14.

    PMID: 18344963BACKGROUND

  • Joshi M, Agrawal S, Christoforidis JB. Inflammatory mechanisms of idiopathic epiretinal membrane formation. Mediators Inflamm. 2013;2013:192582. doi: 10.1155/2013/192582. Epub 2013 Nov 11.

    PMID: 24324293BACKGROUND

  • Gilbert C, Hiscott P, Unger W, Grierson I, McLeod D. Inflammation and the formation of epiretinal membranes. Eye (Lond). 1988;2 Suppl:S140-56. doi: 10.1038/eye.1988.140.

    PMID: 3076143BACKGROUND

  • Hiscott PS, Unger WG, Grierson I, McLeod D. The role of inflammation in the development of epiretinal membranes. Curr Eye Res. 1988 Sep;7(9):877-92. doi: 10.3109/02713688808997245.

    PMID: 3180837BACKGROUND

  • Grinnell F. Fibroblasts, myofibroblasts, and wound contraction. J Cell Biol. 1994 Feb;124(4):401-4. doi: 10.1083/jcb.124.4.401. No abstract available.

    PMID: 8106541BACKGROUND

  • Banerjee PJ, Woodcock MG, Bunce C, Scott R, Charteris DG. A pilot study of intraocular use of intensive anti-inflammatory; triamcinolone acetonide to prevent proliferative vitreoretinopathy in eyes undergoing vitreoretinal surgery for open globe trauma; the Adjuncts in Ocular Trauma (AOT) Trial: study protocol for a randomised controlled trial. Trials. 2013 Feb 13;14:42. doi: 10.1186/1745-6215-14-42.

    PMID: 23406256BACKGROUND

  • Tano Y, Sugita G, Abrams G, Machemer R. Inhibition of intraocular proliferations with intravitreal corticosteroids. Am J Ophthalmol. 1980 Jan;89(1):131-6. doi: 10.1016/0002-9394(80)90239-1.

    PMID: 6153251BACKGROUND

MeSH Terms

Conditions

Epiretinal Membrane

Interventions

prednisolone acetate

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Study Officials

  • Myrna Lichter, MD, FRCSC

    University of Toronto Department of Ophthalmology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2015

First Posted

April 8, 2015

Study Start

August 1, 2015

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

January 29, 2016

Record last verified: 2016-01