Topical Use of Corticosteroid to Prevent Epiretinal Membr... | NCT02412059

Studies
Topical Use of Corticosteroid to Prevent Epiretinal Membrane Following Retinal Tear

NCT02412059

Sponsor

Unity Health Toronto

Status

Completed

Last Update Posted

Jan 29, 2016Estimated

Enrollment

200Actual

Phase

Not Applicable

Conditions

Epiretinal Membrane

Interventions

Prednisolone acetate

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2015

Primary Completion Date

Jan 2016Actual

Completion Date

Jan 2016Actual

First Submitted Date

Apr 3, 2015

First Submission Date that Met QC Criteria

Apr 3, 2015

First Posted Date

Apr 8, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 28, 2016

Last Update Posted Date

Jan 29, 2016Estimated

Name	Class
University of Toronto	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Prednisolone acetate	Drug		Prednisolone	Pred Forte

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of epiretinal membrane		6-months following administration of corticosteroid

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Myrna Lichter, MD, FRCSC	University of Toronto Department of Ophthalmology	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25360790	Background	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.
7573306	Background	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.

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases