Intravitreal Bevacizumab Pretreatment for Reducing Preretinal Hemorrhage in Diabetic Vitrectomy

NCT00596505 | Completed DMC

• 1 other identifier: 200704021M
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

Treatment of severe proliferative diabetic retinopathy (PDR) may require the use of silicone oil for long-term retinal tamponade to prevent recurrent retinal detachment. Massive bleeding during surgery before proper release of traction and peri-silicone oil proliferation after surgery were major causes of surgical failure. The likelihood of reproliferation rises in the presence of significant preretinal blood. It is therefore crucial to reduce intraoperative and postoperative preretinal hemorrhage in complicated diabetic vitrectomy with silicone oil infusion. Intravitreal avastin has been noted to induce rapid regression of retinal and iris neovascularization in proliferative diabetic retinopathy. Further, presurgical administration of intravitreal avastin may reduce intraoperative bleeding during membrane dissection in PDR with traction retinal detachment. The pretreatment of avastin may be particularly beneficial in the treatment of severe active fibrovascular proliferation by decreasing the severity of intraoperative and postoperative intraocular hemorrhage, leading to better surgical outcome and early visual rehabilitation. We conduct a prospective study to evaluate the effect of avastin on the severity of intra- and post-operative bleeding, frequency of recurrent bleeding, and anatomical and functional outcome in eyes with severe active PDR undergoing vitrectomy with silicone oil infusion.

Conditions

Proliferative Diabetic Retinopathy

Keywords

proliferative diabetic retinopathy; bevacizumab (Avastin); vitreous hemorrhage; silicone oil

Outcome Measures

Primary Outcomes (3)

• The severity of intraoperative and postoperative preretinal hemorrhage

  Six months

• Reabsorption time of blood around the disc area

  Six months

• The changes of visual acuity

  Six months

Study Arms (2)

1

Group 1 will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 7 to 9 days before vitrectomy

2

Group 2 will not receive bevacizumab pretreatment

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Consecutive patients undergoing primary pars plana vitrectomy with silicone oil infusion for complications of proliferative diabetic retinopathy will be recruited for the prospective study.

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.

You may not qualify if:

• Not primary pars plana vitrectomy
• post-operative follow-up duration less than three months

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

Condition Hierarchy (Ancestors)

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

Study Officials

• Chung-May Yang, MD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 8, 2008
• First Posted: January 17, 2008
• Study Start: April 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: January 17, 2008

Record last verified: 2008-01

Locations

TW (1)