Outcomes of Intraoperative 5-Fluorouracil Versus Mitomycin C

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ClinicalTrials.gov Identifier: NCT00346489

Recruitment Status : Completed

First Posted : June 30, 2006

Last Update Posted : December 27, 2007

Sponsor:

Information provided by:

Indiana University

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Glaucoma	Drug: 5-fluorouracil Drug: Mitomycin C	Phase 4

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	70 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double
Primary Purpose:	Treatment
Official Title:	Intermediate Term Outcomes of Intraoperative 5-Fluorouracil Versus Mitomycin c in Trabeculectomy Surgery.
Study Start Date :	September 2004
Actual Primary Completion Date :	August 2007
Actual Study Completion Date :	August 2007

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Early-onset glaucoma Hypertension

MedlinePlus related topics: Glaucoma

Drug Information available for: Mitomycin Fluorouracil Mitomycins

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

Pressure Control

Secondary Outcome Measures :

Mitomycin Complications

Eligibility Criteria

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Ages Eligible for Study:	Child, Adult, Older Adult
Sexes Eligible for Study:	All
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

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): NCT00346489

Locations

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United States, Indiana
University Hospital and Outpatient Center
Indianapolis, Indiana, United States, 46202
IU Eye at Carmel
Indianapolis, Indiana, United States, 46290

Sponsors and Collaborators

Indiana University School of Medicine

Investigators

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Principal Investigator:	Louis B Cantor, MD	IUPUI/Clarian

More Information

Publications:

Skuta GL, Beeson CC, Higginbotham EJ, Lichter PR, Musch DC, Bergstrom TJ, Klein TB, Falck FY Jr. Intraoperative mitomycin versus postoperative 5-fluorouracil in high-risk glaucoma filtering surgery. Ophthalmology. 1992 Mar;99(3):438-44.

Kitazawa Y, Kawase K, Matsushita H, Minobe M. Trabeculectomy with mitomycin. A comparative study with fluorouracil. Arch Ophthalmol. 1991 Dec;109(12):1693-8.

Palmer SS. Mitomycin as adjunct chemotherapy with trabeculectomy. Ophthalmology. 1991 Mar;98(3):317-21.

Dunn JP, Seamone CD, Ostler HB, Nickel BL, Beallo A. Development of scleral ulceration and calcification after pterygium excision and mitomycin therapy. Am J Ophthalmol. 1991 Sep 15;112(3):343-4.

Fluorouracil Filtering Surgery Study one-year follow-up. The Fluorouracil Filtering Surgery Study Group. Am J Ophthalmol. 1989 Dec 15;108(6):625-35.

Liebmann JM, Ritch R, Marmor M, Nunez J, Wolner B. Initial 5-fluorouracil trabeculectomy in uncomplicated glaucoma. Ophthalmology. 1991 Jul;98(7):1036-41.

Lee DA, Hersh P, Kersten D, Melamed S. Complications of subconjunctival 5-fluorouracil following glaucoma filtering surgery. Ophthalmic Surg. 1987 Mar;18(3):187-90.

Knapp A, Heuer DK, Stern GA, Driebe WT Jr. Serious corneal complications of glaucoma filtering surgery with postoperative 5-fluorouracil. Am J Ophthalmol. 1987 Feb 15;103(2):183-7.

Khaw PT, Sherwood MB, MacKay SL, Rossi MJ, Schultz G. Five-minute treatments with fluorouracil, floxuridine, and mitomycin have long-term effects on human Tenon's capsule fibroblasts. Arch Ophthalmol. 1992 Aug;110(8):1150-4.

Khaw PT, Doyle JW, Sherwood MB, Grierson I, Schultz G, McGorray S. Prolonged localized tissue effects from 5-minute exposures to fluorouracil and mitomycin C. Arch Ophthalmol. 1993 Feb;111(2):263-7.

Khaw PT, Doyle JW, Sherwood MB, Smith MF, McGorray S. Effects of intraoperative 5-fluorouracil or mitomycin C on glaucoma filtration surgery in the rabbit. Ophthalmology. 1993 Mar;100(3):367-72.

Lanigan L, Stürmer J, Baez KA, Hitchings RA, Khaw PT. Single intraoperative applications of 5-fluorouracil during filtration surgery: early results. Br J Ophthalmol. 1994 Jan;78(1):33-7.

Dietze PJ, Feldman RM, Gross RL. Intraoperative application of 5-fluorouracil during trabeculectomy. Ophthalmic Surg. 1992 Oct;23(10):662-5.

Egbert PR, Williams AS, Singh K, Dadzie P, Egbert TB. A prospective trial of intraoperative fluorouracil during trabeculectomy in a black population. Am J Ophthalmol. 1993 Nov 15;116(5):612-6.

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).

Singh K, Mehta K, Shaikh NM, Tsai JC, Moster MR, Budenz DL, Greenfield DS, Chen PP, Cohen JS, Baerveldt GS, Shaikh S. Trabeculectomy with intraoperative mitomycin C versus 5-fluorouracil. Prospective randomized clinical trial. Ophthalmology. 2000 Dec;107(12):2305-9.

Spaeth GL, Mutlukan E. The use of antimetabolites with trabeculectomy: a critical appraisal. J Glaucoma. 2001 Jun;10(3):145-51. Review.

WuDunn D, Cantor LB, Palanca-Capistrano AM, Hoop J, Alvi NP, Finley C, Lakhani V, Burnstein A, Knotts SL. A prospective randomized trial comparing intraoperative 5-fluorouracil vs mitomycin C in primary trabeculectomy. Am J Ophthalmol. 2002 Oct;134(4):521-8.

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ClinicalTrials.gov Identifier:	NCT00346489 History of Changes
Other Study ID Numbers:	0409-60
First Posted:	June 30, 2006 Key Record Dates
Last Update Posted:	December 27, 2007
Last Verified:	December 2007

Keywords provided by Indiana University:


Trabeculectomy 5-fluorouracil Mitomycin C

Additional relevant MeSH terms:

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Glaucoma Ocular Hypertension Eye Diseases Fluorouracil Mitomycins Mitomycin Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic	Antineoplastic Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antibiotics, Antineoplastic Alkylating Agents Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors

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