Topical Use of Corticosteroid to Prevent Epiretinal Membrane Following Retinal Tear

Epiretinal Membrane Clinical Trial

Official title:

Topical Use of Corticosteroid to Prevent Epiretinal Membrane Formation in Eyes With Retinal Tear Undergoing Laser Retinopexy: a Pilot Prospective Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02412059
• Other study ID #: LichterM
• Status: Completed
• Phase: N/A
• First received: April 3, 2015
• Last updated: January 28, 2016
• Start date: August 2015
• Est. completion date: January 2016

Study information

• Verified date: January 2016
• Source: St. Michael's Hospital, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Description:

Epiretinal membrane (ERM) is a frequent, sight-threatening eye condition occurring in 1.02% - 28.9% of eyes in persons aged 40 years or older. [1] While often idiopathic in nature, ERM formation has been associated with retinal tears, possibly due to a breakdown of the blood-retinal barrier [1-3]. Pathological analysis of ERM content shows inflammatory mediators such as cytokines, growth factors and interleukins, which can promote fibroblast remodelling that leads to a contractile scar formation on the retinal surface. [1, 4-8] For this reason, ERM formation has been suggested to be an aberrant tissue repair or wound-healing process driven by inflammatory reactions. Since corticosteroids inhibit the inflammatory cascade and fibroblast transdifferentiation, administration of a corticosteroid following retinal tears should theoretically reduce the risk of ERM formation. [9-10] In this study, we aim to assess whether administration of a topical corticosteroid would attenuate ERM formation following laser retinopexy of retinal tears.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Between ages 18 to 80 (inclusive)

• English-speaking

• Undergoing non-pneumatic laser retinopexy procedure for horseshoe retinal tear (without retinal detachment)

Exclusion Criteria:

• 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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Epiretinal Membrane

Intervention

Drug:
• Prednisolone acetate

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto	University of Toronto

References & Publications (9)

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. — View Citation

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. Review. — View Citation

Gilbert C, Hiscott P, Unger W, Grierson I, McLeod D. Inflammation and the formation of epiretinal membranes. Eye (Lond). 1988;2 Suppl:S140-56. Review. — View Citation

Grinnell F. Fibroblasts, myofibroblasts, and wound contraction. J Cell Biol. 1994 Feb;124(4):401-4. Review. — View Citation

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. — View Citation

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. Review. — View Citation

Saran BR, Brucker AJ. Macular epiretinal membrane formation and treated retinal breaks. Am J Ophthalmol. 1995 Oct;120(4):480-5. Review. Erratum in: Am J Ophthalmol 1996 Mar;121(3):334. — View Citation

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. — View Citation

Tano Y, Sugita G, Abrams G, Machemer R. Inhibition of intraocular proliferations with intravitreal corticosteroids. Am J Ophthalmol. 1980 Jan;89(1):131-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of epiretinal membrane		6-months following administration of corticosteroid	No