Intravitreal Injection of Bevacizumab and Gas for Diabeti... | NCT00673296

Studies
Intravitreal Injection of Bevacizumab and Gas for Diabetic Premacular Hemorrhage With Active Fibrovascular Proliferation

NCT00673296

Sponsor

National Taiwan University Hospital

Status

Unknown status

Last Update Posted

May 7, 2008Estimated

Enrollment

6Actual

Phase

Not Applicable

Conditions

Diabetic Retinopathy With Premacular Hemorrhage

Interventions

Intravitreal Bevacizumab

Countries

Taiwan

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

Apr 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Apr 2008Actual

Completion Date

Dec 2008Estimated

First Submitted Date

May 5, 2008

First Submission Date that Met QC Criteria

May 5, 2008

First Posted Date

May 7, 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

May 5, 2008

Last Update Posted Date

May 7, 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

Diabetic premacular hemorrhage occurs when blood from preretinal neovascular tissue is entrapped between the retina and the posterior hyaloid in the macular area. It may occur spontaneously or secondary to traction from a localized posterior vitreous detachment. This complication may greatly disturb the central vision and may be an important stimulant of fibrovascular proliferation.

Bevacizumab (Avastin, Genentech, Inc.) is a humanized monoclonal antibody against vascular endothelial growth factor (VEGF), which has been used to treat a variety of neovascular ocular diseases. In proliferative diabetic retinopathy, intravitreal bevacizumab has been shown to induce prompt regression of neovascularization and may enhance resolution of vitreous hemorrhage.

In this study, we propose that simultaneous intravitreal injection of gas and bevacizumab may be a useful treatment option in diabetic premacular hemorrhage with active fibrovascular tissue. In this procedure, gas is used to displace the blood while bevacizumab may render the neovascularization less active to decrease the likelihood of recurrent hemorrhage.

Detailed Description

In this study, consecutive cases of acute diabetic premacular hemorrhage and active fibrovascular proliferation will receive intravitreal injection of bevacizumab (1.25 mg in 0.05 mL) and C3F8 (0.2-0.3 mL) during the same setting. Before intravitreal injection, all patients should either have complete panretinal photocoagulation (PRP) treatment or PRP to the peripheral retina. After treatment, patients will maintain a prone position for three days and be followed at regular interval. After vitreous clear-up, further supplementary PRP extending beyond equator will be done. Snellen best-corrected visual acuity measurements, intraocular pressure, slit-lamp examination and non-contact lens biomicroscopic examination will be performed before treatment and at each follow-up visit. Data including the extent of premacular hemorrhage, and the interval between the treatment and clearing of premacular hemorrhage will also be recorded.

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

6Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Other	Patients receive intravitreal injection of bevacizumab (1.25 mg in 0.05 mL) and C3F8 (0.2-0.3 mL)	Drug: Intravitreal Bevacizumab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intravitreal Bevacizumab	Drug	Intravitreal injection of bevacizumab (1.25 mg in 0.05 mL) and C3F8 (0.2-0.3 mL)	A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Interval between the treatment and clearing of premacular hemorrhage		Before treatment, weekly after the treatment, and monthly after hemorrhage reabsorption

Secondary Outcomes

Measure	Description	Time Frame
Snellen best-corrected visual acuity measurements, intraocular pressure, slit-lamp examination and non-contact lens biomicroscopic examination.		Before treatment, weekly after the treatment, and monthly after hemorrhage reabsorption

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Acute diabetic premacular hemorrhage and minor active fibrovascular proliferation

Exclusion Criteria:

Anticoagulant therapy
Blood diseases associated with abnormal coagulation
Proliferative retinopathy severe enough to warrant vitrectomy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Chung May Yang, M.D.	National Taiwan University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital		Taipei		10002	Taiwan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15633404	Background	Michels RG. Proliferative diabetic retinopathy: pathophysiology of extraretinal complications and principles of vitreous surgery. Retina. 1981;1(1):1-17.
10704565	Background	Yang CM, Chen MS. Tissue plasminogen activator and gas for diabetic premacular hemorrhage. Am J Ophthalmol. 2000 Mar;129(3):393-4. doi: 10.1016/s0002-9394(99)00393-1.