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Sponsored by: |
Shaheed Beheshti Medical University |
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Information provided by: | Shaheed Beheshti Medical University |
ClinicalTrials.gov Identifier: | NCT00370630 |
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 |
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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 |
Estimated Enrollment: | 15 |
Study Start Date: | August 2006 |
Estimated Study Completion Date: | February 2007 |
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.
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Siamak Moradian, MD | +98 21 22585952 | labbafi@hotmail.com |
Iran, Islamic Republic of | |
Siamak Moradian, MD | Recruiting |
Tehran, Iran, Islamic Republic of, 16666 | |
Contact: Siamak Moradian, MD +98 21 22585952 labbafi@hotmail.com |
Principal Investigator: | Siamak Moradian, MD | Ophthalmic Research Center of Shaheed Beheshti Medical University |
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 |
CRVO Intravitreal Avastin Intravitreal triamcinolone |
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 |
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 |