Bevacizumab and Long Acting Gas in Diabetic Vitrectomy

NCT00656435 | Completed Phase 3 DMC

• 1 other identifier: 200709051M
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Persistent or recurrent vitreous hemorrhage after vitrectomy for diabetic retinopathy complications is a common occurrence with an incidence of 12% to 63%. This complication may prolong vitreous clear-up and delay visual rehabilitation significantly, and sometimes requires additional procedures or surgery. The causes of bleeding are diverse. Evidence suggests fibrovascular proliferation from the sclerotomy sites or from the vitreous base may be an important source of recurrent vitreous hemorrhage; other sources of bleeding include iatrogenic intraoperative injury of retinal vessels, and incomplete removal of fibrovascular tissues. We have reported on the possible benefit of peripheral retinal cryotherapy and cryotherapy treatment of sclerotomy sites to prevent delayed-onset recurrent vitreous hemorrhage, and the possible benefit of intravitreal long-acting gas to reduce the occurrence of early postoperative recurrent vitreous hemorrhage, especially for cases with active fibrovascular proliferation. However, minor recurrent vitreous hemorrhage and prolonged reabsorption of lysed blood clots from surgical trauma remain important factors to cause media opacity long enough to prevent quick visual rehabilitation. Intravitreal bevacizumab has been noted to induce rapid regression of retinal and iris neovascularization in proliferative diabetic retinopathy. Further, presurgical administration of intravitreal bevacizumab may reduce intraoperative bleeding during membrane dissection in PDR with traction retinal detachment. We hypothesize that presurgical treatment of intravitreal bevacizumab may reduce intraoperative bleeding and the amount of residual blood clots, while intraoperative infusion of long-acting gas may facilitate post-operative recovery of surgically injured retinal vessels. These combined effects would thus enhance early clear-up of vitreous opacity from clot lysis and recurrent retinal bleeding. To investigate this hypothesis, a clinical prospective study was undertaken to evaluate the effects of bevacizumab pretreatment combined with intravitreal infusion of long-acting gas on the clearance speed and the recurrence rate of early postoperative vitreous hemorrhage in vitrectomy for active diabetic fibrovascular proliferation.

Conditions

Proliferative Diabetic Retinopathy

Keywords

proliferative diabetic retinopathy; bevacizumab (Avastin); vitreous hemorrhage; long acting gas

Outcome Measures

Primary Outcomes (1)

• The severity of intraoperative bleeding and vitreous clear-up time.

  Six months

Secondary Outcomes (1)

• Percentage of prolonged vitreous clear-up (≥ 3 weeks) and recurrent hemorrhage rate.

  Six months

Study Arms (2)

A

EXPERIMENTAL

Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 7 to 9 days before vitrectomy

Drug: Bevacizumab

B

NO INTERVENTION

Patients will not receive bevacizumab pretreatment

Interventions

Bevacizumab DRUG

Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 7 to 9 days before vitrectomy

Also known as: Avastin

A

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• anticoagulant therapy has not been used prior to surgery or during post-operative follow-up period.
• no medical history of blood diseases associated with abnormal blood coagulation is present.
• Having active fibrovascular proliferation with vitreo-retinal adhesions in 3 or more sites but not extending beyond the equator in more than one quadrant.
• Severe retinopathy with anticipation of silicone oil usag
• Age is between 20 to 85 years old.

You may not qualify if:

• Not primary pars plana vitrectomy
• post-operative follow-up duration less than three months
• Pregnancy
• HbA1c \> 8.0

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Department of Ophthalmology, National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Vitreous Hemorrhage

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Eye Hemorrhage; Eye Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Chung-May Yang, MD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 30, 2008
• First Posted: April 11, 2008
• Study Start: December 1, 2006
• Primary Completion: August 1, 2007
• Study Completion: February 1, 2008
• Last Updated: April 11, 2008

Record last verified: 2008-02

Locations

TW (1)