Outcomes of Intraoperative 5-Fluorouracil Versus Mitomycin C - Full Text View

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:

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma

Drug Information available for: Mitomycin Fluorouracil

U.S. FDA Resources

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

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:

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. No abstract available.

[No authors listed] 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, Sturmer 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.

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:

Glaucoma
Ocular Hypertension
Eye Diseases
Mitomycins
Mitomycin
Fluorouracil
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Alkylating Agents
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013