Trabeculectomy With Mitomycin C Associated With Sub-conju... | NCT00892398

Studies
Trabeculectomy With Mitomycin C Associated With Sub-conjunctival Injection of Ranibizumab

NCT00892398

Sponsor

Maisonneuve-Rosemont Hospital

Status

Completed

Last Update Posted

Apr 10, 2014Estimated

Enrollment

242Actual

Phase

Not Applicable

Conditions

Glaucoma

Interventions

ranibizumab
standard care

Countries

Canada

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

Apr 2014

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

Mar 2009

Primary Completion Date

Oct 2013Actual

Completion Date

Mar 2014Actual

First Submitted Date

May 1, 2009

First Submission Date that Met QC Criteria

May 1, 2009

First Posted Date

May 4, 2009Estimated

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

Apr 8, 2014

Last Update Posted Date

Apr 10, 2014Estimated

Name	Class
Novartis	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Trabeculectomy with mitomycin C remains the standard surgery for glaucoma. This surgery involves creating a door in the eye wall in order to improve fluid outflow and decrease intraocular pressure. However, success rates range from 70% to 90% depending on the criteria used and tend to decrease with time. The failure of the surgery is associated with inflammation, new blood vessel formation and scarring which can cause closure of the door. Molecules which inhibit new blood vessel formation such as inhibitors of vascular endothelial growth factor have been used successfully to decrease scarring in animal eyes where little doors were created and significantly improve survival. Furthermore, they have shown promise when used during trabeculectomy. Ranibizumab, a vascular endothelial growth factor, has also been used safely in intraocular surgery to treat other diseases which involve new blood vessel formation such as macular degeneration and diabetes.

The investigators hypothesize that ranibizumab may decrease the failure rate of trabeculectomy with mitomycin C by decreasing scarring.

The aim of the study is to evaluate the difference in failure rates and bleb morphology at one year post-operatively in eyes having undergone sub-conjunctival injections of ranibizumab in addition to primary trabeculectomy with mitomycin C compared to eyes having undergone trabeculectomy with mitomycin C alone.

Detailed Description

Prospective, randomized, unblinded clinical trial. Two groups of patients with glaucoma undergoing primary trabeculectomy or phaco-trabeculectomy with MMC between March 2009 and September 2012. The ranibizumab group (RAN) received 2 subconjunctival injections of 0.5 mg of ranibizumab (intraoperatively and on day 14) and he control group did not receive ranibizumab.

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

242Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ranibizumab	Experimental	Trabeculectomy with mitomycin C associated with 2 subconjunctival injections of ranibizumab: 1 intraoperatively and 1 at 2 weeks post-operatively	Drug: ranibizumab
standard care	Active Comparator	Trabeculectomy with mitomycin C and standard post-operative care	Procedure: standard care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ranibizumab	Drug	Two ranibizumab subconjunctival injections (0.5 mg ∕ 0.05 mL). The first injection at the end of the surgery (intraoperative) and the second two weeks post-operatively.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Failure rates of the surgery as defined by intraocular pressure reductions	Complete success: post-operative IOP between 5-18 mm Hg and at least a 20% reduction in IOP from baseline without the use of glaucoma medications. Qualified success: similar definition with the use of glaucoma medications.	one year

Secondary Outcomes

Measure	Description	Time Frame
Bleb morphology using Moorfields bleb grading system		one year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

to have uncontrolled glaucoma
to have accepted to undergo a primary trabeculectomy with mitomycin C
to have one of the following types of glaucoma:
- Normal tension Glaucoma
- Chronic Open-Angle Glaucoma
- Chronic Angle-Closure Glaucoma
- Mixed mechanism glaucoma
- Steroid-induced Glaucoma
- Neovascular Glaucoma

Exclusion Criteria:

to be less than 18 years old
to be unable to observe the study protocol
to present some risk factors for thromboembolic events and cerebrovascular accidents : hypertension, dyslipidemia, coronary artery diseases
a history of thromboembolic events and cerebrovascular accidents
congenital glaucoma
uveitic glaucoma
to be pregnant
to be breastfeeding
surgical complications prior to injection of the study drug such as vitreous in the anterior chamber or the presence of suprachoroidal hemorrhages
to have undergone a previous conjunctival surgery
to be hypersensitive to the drug, to one of the components of the drug or to one of the components of the packaging
to present an active or suspected intraocular or periocular inflammation
to have a kidney failure
to have a liver failure

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Gisele Li, M.D.	Maisonneuve-Rosemont Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Maisonneuve-Rosemont Hospital		Montreal	Quebec	H1T2M4	Canada

ID	Term
D005901	Glaucoma

ID	Term
D009798	Ocular Hypertension
D005128	Eye Diseases

Intervention Browse Module

MeSH Terms

ID	Term
D000069579	Ranibizumab
D059039	Standard of Care

Ancestor Terms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins

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