NCT00745498

Brief Summary

The purpose of this study is to determine the effect of pre- and intra-operative bevacizumab injection on postoperative vitreous hemorrhage after diabetic vitrectomy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 2, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 3, 2008

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
5.2 years until next milestone

Results Posted

Study results publicly available

December 21, 2015

Completed
Last Updated

December 21, 2015

Status Verified

November 1, 2015

Enrollment Period

2.3 years

First QC Date

September 2, 2008

Results QC Date

June 6, 2012

Last Update Submit

November 17, 2015

Conditions

Proliferative Diabetic RetinopathyVitreous Hemorrhage

Keywords

Proliferative diabetic retinopathyvitrectomybevacizumabvitreous hemorrhage

Outcome Measures

Primary Outcomes (1)

  • Recurrent VH Incidence (Early and Late)

    Recurrent VH was defined as a new episode of grade 1 or more VH occurring more than 1 week after surgery. "Early recurrent VH" was VH occurring \<= 4 weeks and "late recurrent VH" was VH occurring \>4 weeks after surgery.

    6 months

Secondary Outcomes (3)

  • Initial Time of Vitreous Clearing (ITVC)

    6 months

  • Visual Outcome

    6 months

  • Postoperative Resolution of Neovascularization

    6 months

Study Arms (3)

Preop IVB

EXPERIMENTAL

Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 1 to 14 days before vitrectomy

Drug: Bevacizumab

Intraop IVB

EXPERIMENTAL

Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy

Drug: Bevacizumab

No IVB

NO INTERVENTION

Patients will not receive bevacizumab before nor during vitrectomy

Interventions

BevacizumabDRUG

Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml)

Also known as: avastin
Intraop IVBPreop IVB

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing first vitrectomy for complications of proliferative diabetic retinopathy such as vitreous hemorrhage, tractional fibrovascular membrane proliferation, tractional or combined retinal detachment)

You may not qualify if:

  • Follow-up period of less than 6 months
  • Intraoperative use of long-acting gas or silicone oil
  • Repeat vitrectomy after first vitrectomy for diseases other than vitreous hemorrhage
  • Not first vitrectomy
  • Uncontrolled hypertension
  • Medical history of abnormal blood coagulation
  • Time interval between IVB injection and PPV longer than 2 weeks and recent history (within 3 months) of IVB treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam, Gyunggi-do, 463-707, South Korea

Location

Related Publications (1)

  • Chen E, Park CH. Use of intravitreal bevacizumab as a preoperative adjunct for tractional retinal detachment repair in severe proliferative diabetic retinopathy. Retina. 2006 Jul-Aug;26(6):699-700. doi: 10.1097/01.iae.0000225351.87205.69. No abstract available.

    PMID: 16829817BACKGROUND

MeSH Terms

Conditions

Vitreous Hemorrhage

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Eye HemorrhageEye DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Dr. Se Joon Woo
Organization
Seoul National University Bundang Hospital Department of Ophthalmology
sejoon1@hanmail.net
+82-31-787-7377

Study Officials

  • Kyu Hyung Park, M.D.

    Seoul National Univeristy Bundang Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 2, 2008

First Posted

September 3, 2008

Study Start

June 1, 2008

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

December 21, 2015

Results First Posted

December 21, 2015

Record last verified: 2015-11

Locations

KR(1)