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Lucentis Versus Mitomycin C During Glaucoma Surgery

This study has been completed.
Sponsor:
Collaborators:
Genentech
Novartis Pharmaceuticals
Information provided by:
Wills Eye
ClinicalTrials.gov Identifier:
NCT00626782
First received: February 20, 2008
Last updated: August 5, 2011
Last verified: June 2010
History of Changes
  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: 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:

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00626782

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

No publications provided

Responsible Party: Michael Pro, MD, Wills Eye Institute
ClinicalTrials.gov 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:
glaucoma
glucoma filtering surgery
ranibizumab
mitomycin C
patients requiring first time glaucoma filtering surgery

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases
Mitomycins
Mitomycin
Antibiotics, Antineoplastic
Antineoplastic Agents
 Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Alkylating Agents

ClinicalTrials.gov processed this record on June 18, 2013