Intravitreal Bevasizumab Versus Intravitreal Triamcinolone in Branch Retinal Vein Occlusion (BRVO)

• ClinicalTrials.gov Identifier: NCT01044329
• Recruitment Status: Unknown
• First Posted: January 7, 2010
• Last Update Posted: January 7, 2010
• Sponsor: Shahid Beheshti University of Medical Sciences
• Collaborator: Labbafinejad Medical Center
• Information provided by: Shahid Beheshti University of Medical Sciences

Tracking Information

• First Submitted Date: January 6, 2010
• First Posted Date: January 7, 2010
• Last Update Posted Date: January 7, 2010
• Study Start Date: January 2010
• Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 6, 2010): Visual acuity [ Time Frame: 6 months ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures (submitted: January 6, 2010): central macular thickness [ Time Frame: 6 months ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Intravitreal Bevasizumab Versus Intravitreal Triamcinolone in Branch Retinal Vein Occlusion
• Official Title: Three Injections of Intravitreal Bevasizumab Versus Two Injections of Intravitreal Triamcinolone in the Management of Branch Retinal Vein Occlusion
• Brief Summary: This randomized clinical trial is conducted to evaluate the effect of three intravitreal injections of bevasizumab versus two intravitreal injections of triamcinolone in acute retinal vein occlusion. The outcomes are visual acuity and central macular thickness. The follow-up time is 6 months.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Investigator); Primary Purpose: Treatment
• Condition: Branch Retinal Vein Occlusion

Intervention

• Drug: Bevacizumab
  Intravitreal, 1.25 mg, 3 times, one month apart.
• Drug: Triamcinolone Acetonide
  Intravitreal, 2 mg, 2 times, two months apart.

Study Arms

• Active Comparator: Intravitreal bevacizumab
  Intervention: Drug: Bevacizumab
• Active Comparator: Intravitreal triamcinolone
  Intervention: Drug: Triamcinolone Acetonide

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: January 6, 2010): 90
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2010
• Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Recent onset (less than 3 months) BRVO

Exclusion Criteria:

• Any previous intervention

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Iran, Islamic Republic of

Administrative Information

• NCT Number: NCT01044329
• Other Study ID Numbers: 8900
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Alireza ramezani, Ophthamic research center
• Original Responsible Party: Same as current
• Current Study Sponsor: Shahid Beheshti University of Medical Sciences
• Original Study Sponsor: Same as current
• Collaborators: Labbafinejad Medical Center
• Investigators: Not Provided
• PRS Account: Shahid Beheshti University of Medical Sciences
• Verification Date: January 2010