Intravitreal Bevacizumab for Neovascular Glaucoma | NCT00384631

Studies
Intravitreal Bevacizumab for Neovascular Glaucoma

NCT00384631

Sponsor

Shahid Beheshti University of Medical Sciences

Status

Completed

Last Update Posted

Feb 15, 2008Estimated

Enrollment

26Actual

Phase

Not Applicable

Conditions

Neovascular
Glaucoma

Interventions

subconjunctival normal saline
Avastin

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

Feb 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2006

Primary Completion Date

Not provided

Completion Date

Mar 2007Actual

First Submitted Date

Oct 4, 2006

First Submission Date that Met QC Criteria

Oct 4, 2006

First Posted Date

Oct 6, 2006Estimated

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

Feb 14, 2008

Last Update Posted Date

Feb 15, 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

Several studies have confirmed high levels of vascular endothelial growth factor (VEGF) in eyes with neovascular glaucoma (NVG). The role of VEGF inhibitors in regression of other neovascular disorders such as wet-type age-related macular degeneration and diabetic macular edema has been described. We aim to evaluate the effect of three intravitreal injections of bevacizumab (Avastin) 2.5 mg versus a sham procedure for treatment of NVG. Outcome measures include intraocular pressure and extent of iris neovascularization. Both study arms will receive conventional treatment for NVG.

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

26Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
2	Sham Comparator		Other: subconjunctival normal saline
1	Experimental		Drug: Avastin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
subconjunctival normal saline	Other	0.1cc normal saline injection in the subconjunctival space repeated twice at monthly intervals	2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in intraocular pressure		6 months
Change in extent of iris neovascularization		6 months

Secondary Outcomes

Measure	Description	Time Frame
Best corrected visual acuity		6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of NVG
Vision less than 20/200
age 10-80 years

Exclusion Criteria:

Uncontrolled Blood Pressure
History of thromboembolism
Congestive Heart Failure
Renal Failure
Pregnancy or Lactation
Active ocular or periocular infection
No light perception

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Shahin Yazdani, MD	Ophthalmic Research Center, Shaheed Beheshti Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Labbafinejad Medical Center		Tehran	Tehran Province	16666	Iran

ID	Term
D005901	Glaucoma

ID	Term
D009798	Ocular Hypertension
D005128	Eye Diseases

Intervention Browse Module

MeSH Terms

ID	Term
D000068258	Bevacizumab

Ancestor Terms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins

Browse Leaves

Not provided

Browse Branches

Not provided