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Intravitreal Avastin Versus Intravitreal Avastin and Triamcinolone in Central Retinal Vein Occlusion(CRVO)

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Shahid Beheshti University of Medical Sciences

Keywords

Abstract

In this study we intend to evaluate and compare the outcomes of intravitreal avastin versus avastin and triamcinolone on improving the visual acuity and macular edema and late complications of CRVO like NVI and NVG.

Description

Central retinal vein occlusion (CRVO) is a common retinal vascular disorder with potentially complications like reduced vision resulting from extensive intraretinal hemorrhage, retinal ischemia and persistent macular edema and neovascular glaucoma secondary to iris neovascularization. Macular edema is a common cause of severe visual loss in both branch retinal vein occlusion (BRVO) and central retinal vein occlusion (CRVO). Natural history data indicate that CRVO patients presenting with poor visual acuity (_20/200) have an 80% chance of being left with visual acuity less than 20/200 at final visit, whether the CRVO is ischemic or nonischemic at presentation. Treatments that target the secondary effects of venous occlusion, such as grid laser photocoagulation for macular edema and prophylactic panretinal laser photocoagulation for nonperfused CRVO, were shown to be ineffective in improving visual acuity in the Central Vein Occlusion Study (CVOS). Although panretinal photocoagulation is advocated for reducing the risk of neovascular glaucoma in patients with ischemic CRVO, recent clinical trials have failed to demonstrate any significant benefit with laser photocoagulation in the treatment of macular edema due to CRVO. A number of other treatment options are sometimes used in cases of CRVO, such as oral corticosteroids, intravitreal steroids, vitrectomy, hemodilution, intravitreal tissue plasminogen activator, hyperbaric oxygen, and laser or surgical chorioretinal anastomosis. Studies demonstrating the effectiveness of these treatments are inconclusive, although some benefits have been suggested in recent reports. In recent studies the benefit of antiVEGF agents in improving the macular edema due to CRVO have been shown. In this study we are going to compare the effect of intravitreal antiVEGF (Avastin) with combination of Avastin and Triamcinolon in improving the visual acuity and macular thickness in patients with recent (Less than 6 months) CRVO.

Dates

Last Verified: 01/31/2007
First Submitted: 08/30/2006
Estimated Enrollment Submitted: 08/30/2006
First Posted: 08/31/2006
Last Update Submitted: 02/19/2007
Last Update Posted: 02/20/2007
Actual Study Start Date: 07/31/2006
Estimated Study Completion Date: 01/31/2007

Condition or disease

Retinovascular Disease

Intervention/treatment

Drug: Avastin (Bevacizumab) and triamcinolone

Phase

Phase 2

Eligibility Criteria

Ages Eligible for Study 40 Years To 40 Years
Sexes Eligible for StudyAll
Accepts Healthy VolunteersYes
Criteria

Inclusion Criteria:

- CRVO with duration less than 6 months

Exclusion Criteria:

- vision less than 20/320 and vison more than 20/50

- history of galucoma and diabetic retinopathy

- previous laser or intravitreal treatment

- any media opacity that prevents funduscopy

Outcome

Primary Outcome Measures

1. Best corrected visual acuity [undefined]

2. Macular thickness by OCT [undefined]

Secondary Outcome Measures

1. Incidence of NVI [undefined]

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