Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Lucentis Versus Mitomycin C During Glaucoma Surgery

This study has been completed.
Genentech, Inc.
Novartis Pharmaceuticals
Information provided by:
Wills Eye Identifier:
First received: February 20, 2008
Last updated: August 5, 2011
Last verified: June 2010

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.

Condition Intervention Phase
Drug: Ranibizumab
Drug: Mytomycin C 0.4 mg/ml
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Lucentis Versus Mitomycin C as Adjunctive Agent During Trabeculectomy Surgery

Resource links provided by NLM:

Further study details as provided by Wills Eye:

Primary Outcome Measures:
  • Incidence and severity of ocular adverse events and other adverse events as identified by eye examination, physical examination, subject reporting and changes in vital signs. [ Time Frame: 1 day, 2 wks, 1, 3, 6 and 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Mean change in intraocular pressure, number of glaucoma medications, bleb appearance based on Indiana Bleb Appearance grading scale. [ Time Frame: 1 day, 2 wks, 1, 3, 6 and 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 24
Study Start Date: January 2008
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Ranibizumab 0.5mg (0.05mL)
Drug: Ranibizumab
Ranibizumab 0.5mg (0.05mL)one injection in sub-tenon's at the conclusion of glaucoma surgery
Other Name: Lucentis
Active Comparator: B
Mitomycin C 0.4 mg/ml
Drug: Mytomycin C 0.4 mg/ml
Mitomycin C 0.4 mg/ml applied with soaked pledget inserted in the sub-tenon's space during glaucoma surgery.

Detailed Description:

This is an open-label, single center trial with two arms for patients who will undergo 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 over a one year period.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00626782

United States, Pennsylvania
Wills Eye Glaucoma Service
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Wills Eye
Genentech, Inc.
Novartis Pharmaceuticals
Principal Investigator: Michael J Pro, MD Wills Eye Institute
  More Information

No publications provided

Responsible Party: Michael Pro, MD, Wills Eye Institute Identifier: NCT00626782     History of Changes
Other Study ID Numbers: IRB#07-819, rhuFAB v2
Study First Received: February 20, 2008
Last Updated: August 5, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Wills Eye:
glucoma filtering surgery
mitomycin C
patients requiring first time glaucoma filtering surgery

Additional relevant MeSH terms:
Eye Diseases
Ocular Hypertension
Alkylating Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Therapeutic Uses processed this record on March 03, 2015