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Intravitreal Avastin Versus Intravitreal Avastin and Triamcinolone in Central Retinal Vein Occlusion(CRVO)
This study is currently recruiting participants.
Verified by Shaheed Beheshti Medical University, February 2007
First Received: August 31, 2006   Last Updated: February 20, 2007   History of Changes
Sponsored by: Shaheed Beheshti Medical University
Information provided by: Shaheed Beheshti Medical University
ClinicalTrials.gov Identifier: NCT00370630
  Purpose

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 Intervention Phase
Retinovascular Disease
Drug: Avastin (Bevacizumab) and triamcinolone
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Resource links provided by NLM:


Further study details as provided by Shaheed Beheshti Medical University:

Primary Outcome Measures:
  • Best corrected visual acuity
  • Macular thickness by OCT

Secondary Outcome Measures:
  • Incidence of NVI

Estimated Enrollment: 15
Study Start Date: August 2006
Estimated Study Completion Date: February 2007
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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00370630

Contacts
Contact: Siamak Moradian, MD +98 21 22585952 labbafi@hotmail.com

Locations
Iran, Islamic Republic of
Siamak Moradian, MD Recruiting
Tehran, Iran, Islamic Republic of, 16666
Contact: Siamak Moradian, MD     +98 21 22585952     labbafi@hotmail.com    
Sponsors and Collaborators
Shaheed Beheshti Medical University
Investigators
Principal Investigator: Siamak Moradian, MD Ophthalmic Research Center of Shaheed Beheshti Medical University
  More Information

No publications provided

Study ID Numbers: 8544
Study First Received: August 31, 2006
Last Updated: February 20, 2007
ClinicalTrials.gov Identifier: NCT00370630     History of Changes
Health Authority: Iran: Ethics Committee

Keywords provided by Shaheed Beheshti Medical University:
CRVO
Intravitreal Avastin
Intravitreal triamcinolone

Study placed in the following topic categories:
Anti-Inflammatory Agents
Immunologic Factors
Hormone Antagonists
Eye Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Vascular Diseases
Triamcinolone diacetate
Bevacizumab
Angiogenesis Inhibitors
Immunosuppressive Agents
Hormones
Glucocorticoids
Thrombosis
Triamcinolone hexacetonide
Embolism and Thrombosis
Triamcinolone Acetonide
Embolism
Retinal Vein Occlusion
Triamcinolone
Venous Thrombosis
Retinal Diseases

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Bevacizumab
Hormones
Triamcinolone hexacetonide
Triamcinolone Acetonide
Retinal Vein Occlusion
Therapeutic Uses
Triamcinolone
Cardiovascular Diseases
Venous Thrombosis
Growth Inhibitors
Angiogenesis Modulating Agents
Retinal Diseases
Growth Substances
Eye Diseases
Vascular Diseases
Triamcinolone diacetate
Enzyme Inhibitors
Glucocorticoids
Immunosuppressive Agents
Angiogenesis Inhibitors
Thrombosis
Pharmacologic Actions
Embolism and Thrombosis

ClinicalTrials.gov processed this record on September 09, 2009