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

NCT ID: NCT00370630

Last Updated: 2007-02-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2007-02-28

Brief Summary

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.

Detailed 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.

Conditions

Retinovascular Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Interventions

Avastin (Bevacizumab) and triamcinolone

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role: lead

Principal Investigators

Siamak Moradian, MD

Role: PRINCIPAL_INVESTIGATOR

Ophthalmic Research Center of Shaheed Beheshti Medical University

Locations

Siamak Moradian, MD

Tehran, Tehran Province, Iran

Site Status: RECRUITING

Countries

Iran

Central Contacts

Siamak Moradian, MD

Role: CONTACT

labbafi@hotmail.com

+98 21 22585952

Facility Contacts

Siamak Moradian, MD

Role: primary

labbafi@hotmail.com

+98 21 22585952

Other Identifiers

8544

Identifier Type: -

Identifier Source: org_study_id