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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00370630
Recruitment Status : Unknown
Verified February 2007 by Shahid Beheshti University of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : September 1, 2006
Last Update Posted : February 21, 2007
Information provided by:
Shahid Beheshti University of Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Retinovascular Disease Drug: Avastin (Bevacizumab) and triamcinolone Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Study Start Date : August 2006
Study Completion Date : February 2007

Primary Outcome Measures :
  1. Best corrected visual acuity
  2. Macular thickness by OCT

Secondary Outcome Measures :
  1. Incidence of NVI

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00370630

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Contact: Siamak Moradian, MD +98 21 22585952

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Iran, Islamic Republic of
Siamak Moradian, MD Recruiting
Tehran, Iran, Islamic Republic of, 16666
Contact: Siamak Moradian, MD    +98 21 22585952   
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
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Principal Investigator: Siamak Moradian, MD Ophthalmic Research Center of Shaheed Beheshti Medical University
Layout table for additonal information Identifier: NCT00370630    
Other Study ID Numbers: 8544
First Posted: September 1, 2006    Key Record Dates
Last Update Posted: February 21, 2007
Last Verified: February 2007
Keywords provided by Shahid Beheshti University of Medical Sciences:
Intravitreal Avastin
Intravitreal triamcinolone
Additional relevant MeSH terms:
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Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists