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Lucentis Versus Mitomycin C During Glaucoma Surgery

Primary Purpose

Glaucoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ranibizumab
Mitomycin (MMC)
Sponsored by
Wills Eye
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring glaucoma, glucoma filtering surgery, ranibizumab, mitomycin C, patients requiring first time glaucoma filtering surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 yrs or older
  • patients requiring first time glaucoma filtering surgery
  • phakic or pseudophakic
  • must provide written informed consent and comply with study assignments

Exclusion Criteria:

  • Pregnant, lactation or premenopausal women not using adequate contraception.
  • Previous glaucoma surgery, tube shunt surgery, pars plana vitrectomy, scleral buckle, penetrating keratoplasty.
  • Abnormality preventing reliable applanation tonometry in each eye.
  • Current infection or inflammation in either eye.
  • Enrolled in another investigational study.

Sites / Locations

  • Wills Eye Hospital, Glaucoma Service

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A: Ranibizumab 0.5mg (0.05mL) injection

B: Mitomycin C 0.4 mg/ml sponge

Arm Description

Ranibizumab 0.5mg (0.05mL) injection at end of trabeculectomy surgery. This intra-operative adjunct therapy was administered sub-conjunctivally 8-10mm posteriorly to the limbus as an antifibrotic agent.

Mitomycin C 0.4 mg/ml soaked sponge applied to sclera (for up to 2 min) after flap is made during trabeculectomy surgery. This is the typical method used as an antifibrotic agent.

Outcomes

Primary Outcome Measures

Adverse Events
Percentage of participants with ocular adverse events and other adverse events as identified by eye examination, physical examination, subject reporting and changes in vital signs one year post-operatively.

Secondary Outcome Measures

Post-Operative Requirement for Glaucoma Medication
Mean number of glaucoma medications used by each participant over the course of one year post-operatively.

Full Information

First Posted
February 20, 2008
Last Updated
February 23, 2018
Sponsor
Wills Eye
Collaborators
Genentech, Inc., Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00626782
Brief Title
Lucentis Versus Mitomycin C During Glaucoma Surgery
Official Title
Lucentis Versus Mitomycin C as Adjunctive Agent During Trabeculectomy Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wills Eye
Collaborators
Genentech, Inc., Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Does a new add on (or adjunctive) therapy used in glaucoma surgery improve the success of trabeculectomy? Ranibizumab may offer benefit similar to mitomycin C in preventing epi-scleral fibrosis while avoiding the well known complications of mytomycin C which include late bleb leaks, hypotony and infection.
Detailed Description
This is an open-label, single center trial with two arms for patients who underwent guarded filtration surgery to control glaucoma. The control will consist of patients randomly assigned to receive inter-operative mitomycin C 0.4 mg/ml which is applied in a standard fashion with a soaked pledget inserted in the sub-tenon's space during surgery. The study arm will consist of patients randomly assigned to receive a sub-tenon injection of Ranibizumab 0.5 mg/0.05mL with a 30 gauge needle on a tuberculin syringe at the termination of the surgery. No mitomycin C will be applied. Post operative follow-up will consist of a minimum of 6 visits during a one year period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
glaucoma, glucoma filtering surgery, ranibizumab, mitomycin C, patients requiring first time glaucoma filtering surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Patients requiring trabeculectomy were randomly assigned to either MMC or Ranibizumab during surgery.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A: Ranibizumab 0.5mg (0.05mL) injection
Arm Type
Experimental
Arm Description
Ranibizumab 0.5mg (0.05mL) injection at end of trabeculectomy surgery. This intra-operative adjunct therapy was administered sub-conjunctivally 8-10mm posteriorly to the limbus as an antifibrotic agent.
Arm Title
B: Mitomycin C 0.4 mg/ml sponge
Arm Type
Active Comparator
Arm Description
Mitomycin C 0.4 mg/ml soaked sponge applied to sclera (for up to 2 min) after flap is made during trabeculectomy surgery. This is the typical method used as an antifibrotic agent.
Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Other Intervention Name(s)
Lucentis
Intervention Description
Ranibizumab 0.5mg (0.05mL)one injection in sub-tenon's at the conclusion of glaucoma surgery
Intervention Type
Drug
Intervention Name(s)
Mitomycin (MMC)
Other Intervention Name(s)
MMC C 0.4 mg/ml
Intervention Description
Mitomycin (MMC) C 0.4 mg/ml applied with soaked pledget inserted in the sub-tenon's space during glaucoma surgery.
Primary Outcome Measure Information:
Title
Adverse Events
Description
Percentage of participants with ocular adverse events and other adverse events as identified by eye examination, physical examination, subject reporting and changes in vital signs one year post-operatively.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Post-Operative Requirement for Glaucoma Medication
Description
Mean number of glaucoma medications used by each participant over the course of one year post-operatively.
Time Frame
1 day, 2 wks, 1, 3, 6 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 yrs or older patients requiring first time glaucoma filtering surgery phakic or pseudophakic must provide written informed consent and comply with study assignments Exclusion Criteria: Pregnant, lactation or premenopausal women not using adequate contraception. Previous glaucoma surgery, tube shunt surgery, pars plana vitrectomy, scleral buckle, penetrating keratoplasty. Abnormality preventing reliable applanation tonometry in each eye. Current infection or inflammation in either eye. Enrolled in another investigational study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael J Pro, MD
Organizational Affiliation
Wills Eye Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wills Eye Hospital, Glaucoma Service
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25019269
Citation
Pro MJ, Freidl KB, Neylan CJ, Sawchyn AK, Wizov SS, Moster MR. Ranibizumab versus mitomycin C in primary trabeculectomy--a pilot study. Curr Eye Res. 2015 May;40(5):510-5. doi: 10.3109/02713683.2014.935441. Epub 2014 Jul 14.
Results Reference
result

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Lucentis Versus Mitomycin C During Glaucoma Surgery

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