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Lucentis Versus Mitomycin C During Glaucoma Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00626782
First Posted: February 29, 2008
Last Update Posted: December 13, 2017
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.
Collaborators:
Genentech, Inc.
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Michael Pro, Wills Eye
  Purpose
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
Glaucoma Drug: Ranibizumab Drug: Mitomycin C 0.4 mg/ml Phase 2 Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Michael Pro, Wills Eye:

Primary Outcome Measures:
  • Adverse Events [ Time Frame: 1 day, 2 wks, 1, 3, 6 and 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.


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


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) injection
Ranibizumab 0.5mg (0.05mL) injection at end of trabeculectomy surgery. This intra-operative adjunct therapy was administered sub-conjunctivally 8-10mm posteriiorly 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 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.
Other Name: MMC

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00626782


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

Publications:
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
ClinicalTrials.gov Identifier: NCT00626782     History of Changes
Other Study ID Numbers: IRB#07-819
rhuFAB v2 ( Other Grant/Funding Number: Genentec )
First Submitted: February 20, 2008
First Posted: February 29, 2008
Results First Submitted: February 11, 2015
Results First Posted: March 13, 2015
Last Update Posted: December 13, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases
Ranibizumab
Mitomycins
Mitomycin
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