Outcomes of Intraoperative 5-Fluorouracil Versus Mitomycin C

This study has been completed.
Sponsor:
Information provided by:
Indiana University
ClinicalTrials.gov Identifier:
NCT00346489
First received: June 28, 2006
Last updated: December 21, 2007
Last verified: December 2007
  Purpose

A clinical trial to establish the long term response of using intraoperative 5-fluorouracil (5-FU) versus mitomycin C (MMC) in trabeculectomy glaucoma surgery. Antiproliferative agents such as 5-fluorouracil and Mitomycin C have been used extensively in trabeculectomy surgery to improve the success of the surgery and prevent further visual loss and blindness in glaucoma patients.


Condition Intervention Phase
Glaucoma
Drug: 5-fluorouracil
Drug: Mitomycin C
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Intermediate Term Outcomes of Intraoperative 5-Fluorouracil Versus Mitomycin c in Trabeculectomy Surgery.

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Pressure Control

Secondary Outcome Measures:
  • Mitomycin Complications

Estimated Enrollment: 70
Study Start Date: September 2004
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Detailed Description:

Glaucoma is a life-long progressive disease, and patients are living longer. Therefore, a long term full evaluation of the efficacy of intraoperative 5-FU and MMC needs to be performed to assess the true efficacy of MMC compared to 5-FU. We, therefore propose, a long-term prospective study of patients previously enrolled in the prospective study involving the evaluation of single intraoperative application of mitomycin C versus 5-fluorouracil in low to moderate risk glaucoma patients.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Only patients deemed successful as 36 months will be included. These patients will have participated in the randomized prospective study trial comparing intraoperative 5-FU and mitomycin C in primary trabeculectomy.

Exclusion Criteria:

  • Only patients deemed successful as 36 months will be included. These patients will have participated in the randomized prospective study trial comparing intraoperative 5-FU and mitomycin C in primary trabeculectomy.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00346489

Locations
United States, Indiana
IU Eye at Carmel
Indianapolis, Indiana, United States, 46290
University Hospital and Outpatient Center
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University School of Medicine
Investigators
Principal Investigator: Louis B Cantor, MD IUPUI/Clarian
  More Information

Publications:
Smith MF, Doyle JW, Nguyen QH, Sherwood MB. Results of intraoperative 4 fluorouracil or low dose MMC supplementation on primary trabeculectomy surgery. Invest Ophthalmol & Visual Science. 1996,37;#3:S25(Abstract #108).

ClinicalTrials.gov Identifier: NCT00346489     History of Changes
Other Study ID Numbers: 0409-60
Study First Received: June 28, 2006
Last Updated: December 21, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Indiana University:
Trabeculectomy
5-fluorouracil
Mitomycin C

Additional relevant MeSH terms:
Fluorouracil
Mitomycins
Mitomycin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Alkylating Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014