Comparison of Subconjunctival 5-Fluorouracil (FU) Injecti... | NCT00644215

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

NCT00644215

Sponsor

Shahid Beheshti University of Medical Sciences

Status

Unknown status

Last Update Posted

Jun 17, 2008Estimated

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Bleb

Interventions

5-FU and Mitomycin

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2007

Primary Completion Date

Feb 2009Estimated

Completion Date

Not provided

First Submitted Date

Mar 24, 2008

First Submission Date that Met QC Criteria

Mar 25, 2008

First Posted Date

Mar 26, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 16, 2008

Last Update Posted Date

Jun 17, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	5-FU injection has been done	Drug: 5-FU and Mitomycin
2	Experimental	Mitomycin drop has been administrated	Drug: 5-FU and Mitomycin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
5-FU and Mitomycin	Drug	5-FU injection 5mg Mitomycin drop 0.02%	1 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Iop and Bleb height,extent and vascularity		At least in 3 months of follow up

Secondary Outcomes

Measure	Description	Time Frame
complication of 5-FU injection or Mitomycin drop in treatment of early bleb failure

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mohammad pakravan, associated professor	Contact	22590607	009821	mopakravan@yahoo.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
labbafinejad Medical Center,Tehran-Boostan 9 St,Pasdaran Ave,	Recruiting	Tehran	Tehran Province	16666	Iran

Condition Browse Module

MeSH Terms

ID	Term
D001768	Blister

Ancestor Terms

ID	Term
D012872	Skin Diseases, Vesiculobullous
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D020763	Pathological Conditions, Anatomical

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005472	Fluorouracil
D016685	Mitomycin

Ancestor Terms

ID	Term
D014498	Uracil
D011744	Pyrimidinones
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring

Browse Leaves

Not provided

Browse Branches

Not provided