Comparison of Subconjunctival 5-Fluorouracil (FU) Injection and Mitomycin C for Treatment of Early Bleb Failure

This study is currently recruiting participants.

Verified by Shaheed Beheshti Medical University, June 2008

First Received: March 24, 2008 Last Updated: June 16, 2008 History of Changes

Sponsored by:	Shaheed Beheshti Medical University
Information provided by:	Shaheed Beheshti Medical University
ClinicalTrials.gov Identifier:	NCT00644215

Purpose

purpose : to evaluate and compare the effectiveness and complication of 5-FU injections and MMC drop in management of early bleb failure . Design:Randomized clinical trial Methods:Patients with low injected bleb in first month after filtering or combined surgery with MMC which don't respond to high frequent topical steroids and removal of releasable sutures will be randomize to either 5-FU injection or Mitomycin drop 0.02%.For each patient slit photograph in first day of recruiting,first two weeks and first and third month will be obtained.Patients will follow for at least 3 months and IOP ,bleb configuration will check as primary outcome measures.Preoperative and postoperative data,complications,and the need for further surgical procedures will be evaluated.

Condition	Intervention
Bleb	Drug: 5-FU and Mitomycin

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Comparison of Subconjunctival 5-FU Injection and Mitomycin C for Treatment of Early Bleb Failure, a Randomized Clinical Trial

Resource links provided by NLM:

Drug Information available for: Mitomycin Fluorouracil Mitomycins

U.S. FDA Resources

Further study details as provided by Shaheed Beheshti Medical University:

Primary Outcome Measures:

Iop and Bleb height,extent and vascularity [ Time Frame: At least in 3 months of follow up ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

complication of 5-FU injection or Mitomycin drop in treatment of early bleb failure [ Designated as safety issue: Yes ]

Estimated Enrollment:	40
Study Start Date:	June 2007
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 5-FU injection has been done	Drug: 5-FU and Mitomycin 5-FU injection 5mg Mitomycin drop 0.02%
2: Experimental Mitomycin drop has been administrated	Drug: 5-FU and Mitomycin 5-FU injection 5mg Mitomycin drop 0.02%

Eligibility

Ages Eligible for Study:	8 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with low,injected bleb in first month after trabeculectomy or combined trabeculectomy&phaco which not respond to high frequent topical steroids or removal of releasable sutures

Exclusion Criteria:

Injected bleb due to complications of surgery such as button hole formation
Injected bleb due to blebitis
Bleb leakage
Flat AC
Pregnant or nursing mothers
Injected bleb after bleb reconstruction

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00644215

Contacts

Contact: Mohammad pakravan, associated professor

22590607 ext 009821

mopakravan@yahoo.com

Locations

Iran, Islamic Republic of
labbafinejad Medical Center,Tehran-Boostan 9 St,Pasdaran Ave,	Recruiting
Tehran, Iran, Islamic Republic of, 16666
Contact: Mohammad Pakravan, Associated professor l 22590607 mopakravan@yahoo.com
Principal Investigator: Mohammad Pakravan, Assosiated professor
Sub-Investigator: Arezou Miraftabi, M.D

Sponsors and Collaborators

Shaheed Beheshti Medical University

More Information

No publications provided

Responsible Party:	ophthalmic research center ( Mohammad pakravan ,M.D )
Study ID Numbers:	8662
Study First Received:	March 24, 2008
Last Updated:	June 16, 2008
ClinicalTrials.gov Identifier:	NCT00644215 History of Changes
Health Authority:	Iran: Ethics Committee

Keywords provided by Shaheed Beheshti Medical University:

injected bleb
mitomycin drop
5-Fu injection
early bleb failure

Study placed in the following topic categories:

Anti-Bacterial Agents
Fluorouracil
Mitomycin

Alkylating Agents
Mitomycins
Blister

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Mitomycin
Enzyme Inhibitors

Antibiotics, Antineoplastic
Alkylating Agents
Mitomycins
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 10, 2009