Epiretinal MembraneNCT01532765

Randomized Trial Comparing Epiretinal Membrane Surgery With and Without Internal Limiting Membrane Removal

A study testing Pars plana vitrectomy and epiretinal membrane peel, ILM peel assisted by ICG and CE-IOL in people with Epiretinal Membrane, run by Sunnybrook Health Sciences Centre at 3 sites in Canada.

Terminated

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

Official record

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Trial summary

Who is it for?: Ages 18 to 100 yearsHealthy volunteers can take part
Conditions the study is for: Epiretinal Membrane
What is being tested?: Pars plana vitrectomy and epiretinal membrane peel, ILM peel assisted by ICG and CE-IOL
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 13 participants
Where: 3 sitesCanada
Study dates: Sep 2011to 22 Mar 2017
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 18 to 100 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

18 years or older
ERM on clinical exam and/or macular OCT
Visual acuity of 20/40 or worse (attributable to ERM)

Who cannot join

Prior surgery for ERM in the "study eye"
Macular edema secondary to arterial/venous occlusion(s)
Central serous retinopathy
Age related macular degeneration
Diabetic cystoid macular edema
Proliferative Diabetic Retinopathy
Uveitis

Trial locations and contacts

3 sites in 1 country.

Canada3 sites

Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Toronto Western Hospital
Toronto, Ontario, M5T 2S8

Other trials in Canada

About this study

Official title: A Multicentre Randomized Clinical Trial Comparing Epiretinal Membrane Surgery With and Without Internal Limiting Membrane Peeling

Macular epiretinal membrane (ERM) is a semitranslucent, avascular, fibrocellular membrane on the inner surface along the internal limiting membrane (ILM) of the retina. ERM may cause symptomatic visual disturbances and vision loss. Since the 1970s, pars plana vitrectomy has been performed to remove the membranes with few complications, and surgical results are generally good. Recurrence rates of 5-16% have been reported. Recently, ILM peeling in ERM surgery have been popularized by a number of retrospective studies and one prospective case series to minimize the rate of ERM recurrences (16% recurrence in ERM surgery with ILM peel compares to 0% recurrence in ERM surgery without ILM peel). Surgical removal of the friable and transparent ILM is difficult and increases the risk of trauma to the retina. In addition, indocyanine green (ICG), a dye commonly used intra-operatively to enhance ILM visualization, is costly and has been shown to be toxic to the retina. The investigators study will be the first randomized-controlled multi-centred clinical trial to compare the outcomes of ERM surgery with and without ILM peeling. The results will help guide and standardize the surgical treatment of macular ERM; to minimize unnecessary surgical risks, as well as to help economize healthcare cost.

Conditions: Epiretinal Membrane
Being tested: Pars plana vitrectomy and epiretinal membrane peel, ILM peel assisted by ICG, CE-IOL
Keywords: Internal limiting membrane, Indocyanine green dye
Medical subject headings: Epiretinal Membrane

What participants receive

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

Pars plana vitrectomy and epiretinal membrane peelProcedure or surgery
23 gauge pars plana vitrectomy with diluted intravitreal triamcinolone for visualization
ILM peel assisted by ICGProcedure or surgery
Indocyanine green dye is prepared from 25mg powder vial from AKORN INC., 10 mL diluent provided in kit. This is further diluted to final concentration of 0.5mg/mL using 50% sterile dextrose solution
CE-IOLProcedure or surgery
Cataract extraction by phacoemulsification and insertion foldable posterior chamber intraocular lens implant

Study groups in NCT01532765
Study group	Role	What they receive
Epiretinal Membrane Surgery without ILM peel	Active comparator	Not described Receives: Procedure: Pars plana vitrectomy and epiretinal membrane peel
Epiretinal Membrane Surgery with ILM peel (ICG assisted)	Active comparator	Not described Receives: Procedure: Pars plana vitrectomy and epiretinal membrane peel; Procedure: ILM peel assisted by ICG
Combined CE & IOL and ERM surgery without ILM peel	Active comparator	Not described Receives: Procedure: Pars plana vitrectomy and epiretinal membrane peel; Procedure: CE-IOL
Combined CE & IOL and ERM surgery with ILM peel (ICG assisted)	Active comparator	Not described Receives: Procedure: Pars plana vitrectomy and epiretinal membrane peel; Procedure: ILM peel assisted by ICG; Procedure: CE-IOL

What is being measured

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

Change from baseline in macular thickness on optical coherence tomography at 6 months post-surgery (intervention)
Measured: Comparing change at 6 months following surgery and baseline
Change from baseline in visual acuity at 6 months post-surgery (intervention)
Measured: Comparing change of visual acuity at 6 months following surgery and baseline

Secondary outcomes (9)

Change from baseline in macular thickness on optical coherence tomography at 1 month post-surgery (intervention)
Measured: 1 month following surgery
Change from baseline in macular thickness on optical coherence tomography at 12 months post-surgery
Measured: 12 months following surgery
Change from baseline in visual acuity at 1 month post-surgery (intervention)
Measured: 1 month following surgery (intervention)
Change from baseline in visual acuity at 3 months post-surgery (intervention)
Measured: 3 months following surgery (intervention)
Change from baseline in visual acuity at 12 months post-surgery (intervention)
Measured: 12 months following surgery (intervention)
Change from baseline in visual function score based on responses to a validated visual function questionnaire (14 items) at 1 month post-surgery (intervention)
Measured: 1 month following surgery (intervention)
Change from baseline in visual function score based on responses to a validated visual function questionnaire (14 items) at 3 months post-surgery (intervention)
Measured: 3 months following surgery
Change from baseline in visual function score based on responses to a validated visual function questionnaire (14 items) at 6 months post-surgery (intervention)
Measured: 6 months following surgery
Change from baseline in visual function score based on responses to a validated visual function questionnaire (14 items) at 12 months post-surgery (intervention)
Measured: 12 months following surgery

Timeline

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

Sep 201122 Mar 2017

First posted14 Feb 2012 (estimated)
Study startSep 2011
Primary completionMay 2015
Study completion22 Mar 2017

Why it stopped: Resident Project which was not followed through after graduation

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (28)Papers the sponsor has linked to this study.
Other trials for Epiretinal MembraneStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 13 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01532765
Sponsor's protocol ID: 422-2010
Status last verified: Dec 2015
First submitted: 13 Jan 2012
Last updated: 21 Sep 2018
Results posted: No
Data monitoring committee: No

Publications

Shimada H, Nakashizuka H, Hattori T, Mori R, Mizutani Y, Yuzawa M. Double staining with brilliant blue G and double peeling for epiretinal membranes. Ophthalmology. 2009 Jul;116(7):1370-6. doi: 10.1016/j.ophtha.2009.01.024. Epub 2009 May 8.
PubMed 19427701
Wise GN. Preretinal macular fibrosis. (An analysis of 90 cases). Trans Ophthalmol Soc U K (1962). 1972;92:131-40. No abstract available.
PubMed 4515504
Fraser-Bell S, Ying-Lai M, Klein R, Varma R; Los Angeles Latino Eye Study. Prevalence and associations of epiretinal membranes in latinos: the Los Angeles Latino Eye Study. Invest Ophthalmol Vis Sci. 2004 Jun;45(6):1732-6. doi: 10.1167/iovs.03-1295.
PubMed 15161833
Klein R, Klein BE, Wang Q, Moss SE. The epidemiology of epiretinal membranes. Trans Am Ophthalmol Soc. 1994;92:403-25; discussion 425-30. No abstract available.
PubMed 7886875
Hirokawa H, Jalkh AE, Takahashi M, Takahashi M, Trempe CL, Schepens CL. Role of the vitreous in idiopathic preretinal macular fibrosis. Am J Ophthalmol. 1986 Feb 15;101(2):166-9. doi: 10.1016/0002-9394(86)90589-1.
PubMed 3946531
Wise GN. Relationship of idiopathic preretinal macular fibrosis to posterior vitreous detachment. Am J Ophthalmol. 1975 Mar;79(3):358-62. doi: 10.1016/0002-9394(75)90606-6.
PubMed 1121991
Mitchell P, Smith W, Chey T, Wang JJ, Chang A. Prevalence and associations of epiretinal membranes. The Blue Mountains Eye Study, Australia. Ophthalmology. 1997 Jun;104(6):1033-40. doi: 10.1016/s0161-6420(97)30190-0.
PubMed 9186446
Kawasaki R, Wang JJ, Sato H, Mitchell P, Kato T, Kawata S, Kayama T, Yamashita H, Wong TY. Prevalence and associations of epiretinal membranes in an adult Japanese population: the Funagata study. Eye (Lond). 2009 May;23(5):1045-51. doi: 10.1038/eye.2008.238. Epub 2008 Aug 8.
PubMed 19440207
Smiddy WE, Maguire AM, Green WR, Michels RG, de la Cruz Z, Enger C, Jaeger M, Rice TA. Idiopathic epiretinal membranes. Ultrastructural characteristics and clinicopathologic correlation. Ophthalmology. 1989 Jun;96(6):811-20; discussion 821. doi: 10.1016/s0161-6420(89)32811-9.
PubMed 2740079
Wiznia RA. Posterior vitreous detachment and idiopathic preretinal macular gliosis. Am J Ophthalmol. 1986 Aug 15;102(2):196-8. doi: 10.1016/0002-9394(86)90144-3.
PubMed 3740180
Sidd RJ, Fine SL, Owens SL, Patz A. Idiopathic preretinal gliosis. Am J Ophthalmol. 1982 Jul;94(1):44-8. doi: 10.1016/0002-9394(82)90189-1.
PubMed 7091281
Bellhorn MB, Friedman AH, Wise GN, Henkind P. Ultrastructure and clinicopathologic correlation of idiopathic preretinal macular fibrosis. Am J Ophthalmol. 1975 Mar;79(3):366-73. doi: 10.1016/0002-9394(75)90608-x.
PubMed 1121993
Clarkson JG, Green WR, Massof D. A histopathologic review of 168 cases of preretinal membrane. 1977. Retina. 2005 Jul-Aug;25(5 Suppl):1-17. doi: 10.1097/00006982-200507001-00006. No abstract available.
PubMed 16049358
Appiah AP, Hirose T, Kado M. A review of 324 cases of idiopathic premacular gliosis. Am J Ophthalmol. 1988 Nov 15;106(5):533-5. doi: 10.1016/0002-9394(88)90581-8.
PubMed 3189467
Ting FS, Kwok AK. Treatment of epiretinal membrane: an update. Hong Kong Med J. 2005 Dec;11(6):496-502.
PubMed 16340027

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Not yet recruiting
Macular Resurfacing Using Autologous ILM Patch Transposition for Idiopathic Epiretinal Membrane
Idiopathic Epiretinal Membrane

All Epiretinal Membrane trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicentre Randomized Clinical Trial Comparing Epiretinal Membrane Surgery With and Without Internal Limiting Membrane Peeling
ClinicalTrials.gov ID: NCT01532765
Acronym / sponsor ID: 422-2010
Conditions: Epiretinal Membrane
Keywords: Internal limiting membrane, Indocyanine green dye
Study type: Interventional
Recruitment status: TerminatedReason stopped: Resident Project which was not followed through after graduation
Enrolment: 13 participants (actual)
Lead sponsor: Sunnybrook Health Sciences CentreUniversity, hospital or other
Study start: Sep 2011
Primary completion: May 2015 (actual)
Study completion: 22 Mar 2017 (actual)
First posted: 14 Feb 2012 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Epiretinal Membrane Surgery without ILM peel	Active comparator	Procedure: Pars plana vitrectomy and epiretinal membrane peel
Epiretinal Membrane Surgery with ILM peel (ICG assisted)	Active comparator	Procedure: Pars plana vitrectomy and epiretinal membrane peel, Procedure: ILM peel assisted by ICG
Combined CE & IOL and ERM surgery without ILM peel	Active comparator	Procedure: Pars plana vitrectomy and epiretinal membrane peel, Procedure: CE-IOL
Combined CE & IOL and ERM surgery with ILM peel (ICG assisted)	Active comparator	Procedure: Pars plana vitrectomy and epiretinal membrane peel, Procedure: ILM peel assisted by ICG, Procedure: CE-IOL

Who may qualify

Ages: 18 to 100 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

18 years or older
ERM on clinical exam and/or macular OCT
Visual acuity of 20/40 or worse (attributable to ERM)

Key exclusion criteria (7 listed)

Prior surgery for ERM in the "study eye"
Macular edema secondary to arterial/venous occlusion(s)
Central serous retinopathy
Age related macular degeneration
Diabetic cystoid macular edema

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Pars plana vitrectomy and epiretinal membrane peel23 gauge pars plana vitrectomy with diluted intravitreal triamcinolone for visualization	Procedure or surgery	Combined CE & IOL and ERM surgery with ILM peel (ICG assisted), Combined CE & IOL and ERM surgery without ILM peel, Epiretinal Membrane Surgery with ILM peel (ICG assisted), Epiretinal Membrane Surgery without ILM peel
ILM peel assisted by ICGIndocyanine green dye is prepared from 25mg powder vial from AKORN INC., 10 mL diluent provided in kit. This is further diluted to final concentration of 0.5mg/mL using 50% sterile dextrose solution	Procedure or surgery	Combined CE & IOL and ERM surgery with ILM peel (ICG assisted), Epiretinal Membrane Surgery with ILM peel (ICG assisted)
CE-IOLCataract extraction by phacoemulsification and insertion foldable posterior chamber intraocular lens implant	Procedure or surgery	Combined CE & IOL and ERM surgery with ILM peel (ICG assisted), Combined CE & IOL and ERM surgery without ILM peel

Primary outcome

Change from baseline in macular thickness on optical coherence tomography at 6 months post-surgery (intervention)
Time frame: Comparing change at 6 months following surgery and baseline
Change from baseline in visual acuity at 6 months post-surgery (intervention)
Time frame: Comparing change of visual acuity at 6 months following surgery and baseline

9 secondary outcomes

Change from baseline in macular thickness on optical coherence tomography at 1 month post-surgery (intervention)
Time frame: 1 month following surgery
Change from baseline in macular thickness on optical coherence tomography at 12 months post-surgery
Time frame: 12 months following surgery
Change from baseline in visual acuity at 1 month post-surgery (intervention)
Time frame: 1 month following surgery (intervention)
Change from baseline in visual acuity at 3 months post-surgery (intervention)
Time frame: 3 months following surgery (intervention)
Change from baseline in visual acuity at 12 months post-surgery (intervention)
Time frame: 12 months following surgery (intervention)
Change from baseline in visual function score based on responses to a validated visual function questionnaire (14 items) at 1 month post-surgery (intervention)
Time frame: 1 month following surgery (intervention)
Change from baseline in visual function score based on responses to a validated visual function questionnaire (14 items) at 3 months post-surgery (intervention)
Time frame: 3 months following surgery
Change from baseline in visual function score based on responses to a validated visual function questionnaire (14 items) at 6 months post-surgery (intervention)
Time frame: 6 months following surgery
Change from baseline in visual function score based on responses to a validated visual function questionnaire (14 items) at 12 months post-surgery (intervention)
Time frame: 12 months following surgery

Results and safety

The study was stopped early (reason given: Resident Project which was not followed through after graduation). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2018.
Background: PubMed 19427701Shimada H, Nakashizuka H, Hattori T, Mori R, Mizutani Y, Yuzawa M. Double staining with brilliant blue G and double peeling for epiretinal membranes. Ophthalmology. 2009 Jul;116(7):1370-6. doi: 10.1016/j.ophtha.2009.01.024. Epub 2009 May 8.
Background: PubMed 4515504Wise GN. Preretinal macular fibrosis. (An analysis of 90 cases). Trans Ophthalmol Soc U K (1962). 1972;92:131-40. No abstract available.
Background: PubMed 15161833Fraser-Bell S, Ying-Lai M, Klein R, Varma R; Los Angeles Latino Eye Study. Prevalence and associations of epiretinal membranes in latinos: the Los Angeles Latino Eye Study. Invest Ophthalmol Vis Sci. 2004 Jun;45(6):1732-6. doi: 10.1167/iovs.03-1295.
Background: PubMed 7886875Klein R, Klein BE, Wang Q, Moss SE. The epidemiology of epiretinal membranes. Trans Am Ophthalmol Soc. 1994;92:403-25; discussion 425-30. No abstract available.
Background: PubMed 3946531Hirokawa H, Jalkh AE, Takahashi M, Takahashi M, Trempe CL, Schepens CL. Role of the vitreous in idiopathic preretinal macular fibrosis. Am J Ophthalmol. 1986 Feb 15;101(2):166-9. doi: 10.1016/0002-9394(86)90589-1.
Background: PubMed 1121991Wise GN. Relationship of idiopathic preretinal macular fibrosis to posterior vitreous detachment. Am J Ophthalmol. 1975 Mar;79(3):358-62. doi: 10.1016/0002-9394(75)90606-6.
Background: PubMed 9186446Mitchell P, Smith W, Chey T, Wang JJ, Chang A. Prevalence and associations of epiretinal membranes. The Blue Mountains Eye Study, Australia. Ophthalmology. 1997 Jun;104(6):1033-40. doi: 10.1016/s0161-6420(97)30190-0.
Background: PubMed 19440207Kawasaki R, Wang JJ, Sato H, Mitchell P, Kato T, Kawata S, Kayama T, Yamashita H, Wong TY. Prevalence and associations of epiretinal membranes in an adult Japanese population: the Funagata study. Eye (Lond). 2009 May;23(5):1045-51. doi: 10.1038/eye.2008.238. Epub 2008 Aug 8.
Background: PubMed 2740079Smiddy WE, Maguire AM, Green WR, Michels RG, de la Cruz Z, Enger C, Jaeger M, Rice TA. Idiopathic epiretinal membranes. Ultrastructural characteristics and clinicopathologic correlation. Ophthalmology. 1989 Jun;96(6):811-20; discussion 821. doi: 10.1016/s0161-6420(89)32811-9.
Background: PubMed 3740180Wiznia RA. Posterior vitreous detachment and idiopathic preretinal macular gliosis. Am J Ophthalmol. 1986 Aug 15;102(2):196-8. doi: 10.1016/0002-9394(86)90144-3.
Background: PubMed 7091281Sidd RJ, Fine SL, Owens SL, Patz A. Idiopathic preretinal gliosis. Am J Ophthalmol. 1982 Jul;94(1):44-8. doi: 10.1016/0002-9394(82)90189-1.
Background: PubMed 1121993Bellhorn MB, Friedman AH, Wise GN, Henkind P. Ultrastructure and clinicopathologic correlation of idiopathic preretinal macular fibrosis. Am J Ophthalmol. 1975 Mar;79(3):366-73. doi: 10.1016/0002-9394(75)90608-x.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 inclusion and 7 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 21 Sep 2018. 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 Canada. 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: Resident Project which was not followed through after graduation). 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?

Change from baseline in macular thickness on optical coherence tomography at 6 months post-surgery (intervention) (time frame: Comparing change at 6 months following surgery and baseline). The study lists 2 primary outcomes in all. 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 NCT01532765, which also lists 28 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 21 Sep 2018; AzTrials last refreshed its copy on 30 Oct 2026.