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

NCT00673296 | Unknown DMC

• 1 other identifier: 200711050R
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Retinopathy With Premacular Hemorrhage

Keywords

Bevacizumab; Diabetic premacular hemorrhage; Intravitreal gas

Outcome Measures

Primary Outcomes (1)

• Interval between the treatment and clearing of premacular hemorrhage

  Before treatment, weekly after the treatment, and monthly after hemorrhage reabsorption

Secondary Outcomes (1)

• 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

Study Arms (1)

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

Intravitreal Bevacizumab DRUG

Intravitreal injection of bevacizumab (1.25 mg in 0.05 mL) and C3F8 (0.2-0.3 mL)

A

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute diabetic premacular hemorrhage and minor active fibrovascular proliferation

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Related Publications (8)

• Michels RG. Proliferative diabetic retinopathy: pathophysiology of extraretinal complications and principles of vitreous surgery. Retina. 1981;1(1):1-17.

  PMID: 15633404 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.

  PMID: 10704565 BACKGROUND

• Chung J, Kim MH, Chung SM, Chang KY. The effect of tissue plasminogen activator on premacular hemorrhage. Ophthalmic Surg Lasers. 2001 Jan-Feb;32(1):7-12.

  PMID: 11195747 BACKGROUND

• Lynch SS, Cheng CM. Bevacizumab for neovascular ocular diseases. Ann Pharmacother. 2007 Apr;41(4):614-25. doi: 10.1345/aph.1H316. Epub 2007 Mar 13.

  PMID: 17355998 BACKGROUND

• Spaide RF, Fisher YL. Intravitreal bevacizumab (Avastin) treatment of proliferative diabetic retinopathy complicated by vitreous hemorrhage. Retina. 2006 Mar;26(3):275-8. doi: 10.1097/00006982-200603000-00004.

  PMID: 16508426 BACKGROUND

• Verheul HM, Jorna AS, Hoekman K, Broxterman HJ, Gebbink MF, Pinedo HM. Vascular endothelial growth factor-stimulated endothelial cells promote adhesion and activation of platelets. Blood. 2000 Dec 15;96(13):4216-21.

  PMID: 11110694 BACKGROUND

• Arevalo JF, Maia M, Flynn HW Jr, Saravia M, Avery RL, Wu L, Eid Farah M, Pieramici DJ, Berrocal MH, Sanchez JG. Tractional retinal detachment following intravitreal bevacizumab (Avastin) in patients with severe proliferative diabetic retinopathy. Br J Ophthalmol. 2008 Feb;92(2):213-6. doi: 10.1136/bjo.2007.127142. Epub 2007 Oct 26.

  PMID: 17965108 BACKGROUND

• Shih CW, Yang CM, Chen MS, Wang TJ. Intravitreal injection of bevacizumab and gas for diabetic premacular hemorrhage with active fibrovascular proliferation. Graefes Arch Clin Exp Ophthalmol. 2008 Nov;246(11):1547-51. doi: 10.1007/s00417-008-0902-8. Epub 2008 Aug 6.

  PMID: 18682973 DERIVED

Study Officials

• Chung May Yang, M.D.

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 5, 2008
• First Posted: May 7, 2008
• Study Start: January 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: December 1, 2008
• Last Updated: May 7, 2008

Record last verified: 2008-04

Locations

TW (1)