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Lucentis Versus Mitomycin C During Glaucoma Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00626782
Recruitment Status : Completed
First Posted : February 29, 2008
Results First Posted : March 13, 2015
Last Update Posted : March 22, 2018
Genentech, Inc.
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Michael Pro, Wills Eye

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.

Condition or disease Intervention/treatment Phase
Glaucoma Drug: Ranibizumab Drug: Mitomycin (MMC) Phase 2 Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients requiring trabeculectomy were randomly assigned to either MMC or Ranibizumab during surgery.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Lucentis Versus Mitomycin C as Adjunctive Agent During Trabeculectomy Surgery
Study Start Date : January 2008
Primary Completion Date : April 2011
Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care Glaucoma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: A: Ranibizumab 0.5mg (0.05mL) injection
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.
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 sponge
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.
Drug: Mitomycin (MMC)
Mitomycin (MMC) C 0.4 mg/ml applied with soaked pledget inserted in the sub-tenon's space during glaucoma surgery.
Other Name: MMC C 0.4 mg/ml

Primary Outcome Measures :
  1. Adverse Events [ Time Frame: 12 months ]
    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 :
  1. Post-Operative Requirement for Glaucoma Medication [ Time Frame: 1 day, 2 wks, 1, 3, 6 and 12 months ]
    Mean number of glaucoma medications used by each participant over the course of one year post-operatively.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00626782

United States, Pennsylvania
Wills Eye Hospital, 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

Publications of Results:
Pro, MJ, Sawchyn AK, Ichhpujani P, Wizov S, Moster MR, Spaeth GL. Intraoperative Ranibizumab versus Mitomycin-C in Primary Trabeculectomy - A Pilot Study. ARVO E-abstract 619/A463 2010.

Responsible Party: Michael Pro, Principal Investigator, Wills Eye Identifier: NCT00626782     History of Changes
Other Study ID Numbers: IRB#07-819
rhuFAB v2 ( Other Grant/Funding Number: Genentec )
First Posted: February 29, 2008    Key Record Dates
Results First Posted: March 13, 2015
Last Update Posted: March 22, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Ocular Hypertension
Eye Diseases
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Antibiotics, Antineoplastic
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors