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NCT00906685 Clinical Trial

Bevacizumab for Central Retinal Vein Occlusion Study

Central Retinal Vein Occlusion Clinical Trial

Official title:
A Prospective, Randomized, Controlled Study on Intravitreal Bevacizumab (Avastin) for Central Retinal Vein Occlusion (CRVO)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00906685
Other study ID # ACRVO
Secondary ID
Status Completed
Phase Phase 3
First received May 20, 2009
Last updated November 21, 2011
Start date May 2009
Est. completion date September 2011

Study information
Verified date November 2011
Source St. Erik Eye Hospital
Contact n/a
Is FDA regulated No
Health authority Sweden: Medical Products Agency
Study type Interventional

Clinical Trial Summary

Central retinal vein occlusion is a leading cause of severe visual impairment. Until now, no treatment has been available to improve visual acuity. The present study intends to investigate if intravitreal bevacizumab can improve visual acuity as compared to sham-treated control patients.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date September 2011
Est. primary completion date March 2011
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- CRVO with duration < 6 months

- Visual acuity of 20/800 to 20/50

Exclusion Criteria:

- CRVO with duration of > 6 months

- previous treatment with anti-angiogenic drugs

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• bevacizumab
Intravitreal injection of 1.25 mg bevacizumab
• Sham bevacizumab injection
Sham intravitreal injection

Locations
Country Name City State
Sweden St Eriks Eye Hospital Stockholm

Sponsors (1)
Lead Sponsor Collaborator
Anders Kvanta

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary The proportion of patients gaining 15 ETDRS letters or more 6 months No
Secondary Change in foveal thickness 6 months No
Secondary Cases of neovascular glaucoma 6 months No
See also
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Completed NCT01969708 - Study of Comparative Treatments for Retinal Vein Occlusion 2 (SCORE2) Phase 3
Completed NCT01231633 - Comparison of Initial Ozurdex (Dexamethasone Implant) to Avastin (Bevacizumab) for Treatment of Macular Edema Caused by Central Retinal Vein Occlusion (CRVO) N/A
Terminated NCT00969293 - Study to Assess the Safety and Tolerability of a Single Administration of FOV2302 (Ecallantide) in Patients With Macular Edema Associated With Central Retinal Vein Occlusion Phase 1
Completed NCT03981549 - Treatment of Central Retinal Vein Occlusion Using Stem Cells Study Phase 1/Phase 2
Completed NCT02274259 - Comparing Injection Frequency Between Aflibercept and Ranibizumab in Patients With CRVO With a Treat& Extend Regimen Phase 4
Completed NCT01360385 - Retinal Ischemia in Central Retinal Vein Occlusion, and the Effects of Treatment With Intravitreal Ranibizumab N/A
Not yet recruiting NCT00383773 - Retinal Endo Vascular Surgery for Central Retinal Vein Occlusion N/A
Completed NCT00952614 - A Study of a Sustained Release Fluocinolone Implant for Treatment of Central Retinal Vein Occlusion N/A
Recruiting NCT04601701 - Central Retinal Vein Occlusion (CRVO) Treatment With Bevacizumab and Dexamethasone or Bevacizumab Only. N/A
Withdrawn NCT03417401 - Surgical Stabilizer Assisted RVC With rtPA for CRVO Phase 1
Completed NCT01976312 - Ranibizumab Intravitreal Injections Versus Sham Control in Patients With Central Retinal Vein Occlusion (CRVO) Phase 3
Completed NCT01724554 - Impact of Intravitreal Aflibercept Injections on Capillary Non-Perfusion Phase 1/Phase 2
Completed NCT01471691 - Intravitreal Ranibizumab 0.5MG, or 1.0mg for RVO With Macular Edema Previously Receiving Bevacizumab Phase 1/Phase 2
Active, not recruiting NCT01011374 - Impact of Lucentis on Psychological Morbidity in Patients With Retinal Vein Occlusion Phase 1
Completed NCT03223714 - Conbercept Ophthalmic Injection for Patients of Central Retinal Vein Occlusion Phase 3
Recruiting NCT01827722 - Ozurdex Versus Ranibizumab Versus Combination for Central Retinal Vein Occlusion Phase 4
Active, not recruiting NCT04793100 - Spontaneous Retinal Artery Pulses (SPARs) as a Prognostic Determinant of Central Retinal Vein Occlusions (CRVO) in Patients With or Without Intravitreal Aflibercept Injections N/A
Recruiting NCT02405741 - Hyperbaric Chamber for Central Retinal Vein Occlusion (CRVO) Patients Phase 2
Recruiting NCT01348633 - Retinal Oxygen Saturation, Blood Flow, Vascular Function and High Resolution Morphometric Imaging in the Living Human Eye N/A