Bevacizumab for Central Retinal Vein Occlusion Study

• Sponsor: Anders Kvanta (Other)
• Overall Status: Completed
• CT.gov ID: NCT00906685
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Duration (Months): 28
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Central Retinal Vein Occlusion	Drug: bevacizumab; Drug: Sham bevacizumab injection	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Prospective, Randomized, Controlled Study on Intravitreal Bevacizumab (Avastin) for Central Retinal Vein Occlusion (CRVO)
• Study Start Date: May 1, 2009
• Actual Primary Completion Date: Mar 1, 2011
• Actual Study Completion Date: Sep 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Intravitreal bevacizumab	Drug: bevacizumab; Intravitreal injection of 1.25 mg bevacizumab
Sham Comparator: Sham injection	Drug: Sham bevacizumab injection; Sham intravitreal injection

Outcome Measures

Primary Outcome Measures

1. The proportion of patients gaining 15 ETDRS letters or more [6 months]

Secondary Outcome Measures

1. Change in foveal thickness [6 months]

2. Cases of neovascular glaucoma [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St Eriks Eye Hospital	Stockholm		Sweden	11282

Sponsors and Collaborators

• Anders Kvanta

Investigators

• Principal Investigator: Anders Kvanta, MD, PhD, St Eriks Eye Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Anders Kvanta, Professor, St. Erik Eye Hospital
• ClinicalTrials.gov Identifier: NCT00906685
• Other Study ID Numbers: ACRVO
• First Posted: May 21, 2009
• Last Update Posted: Nov 22, 2011
• Last Verified: Nov 1, 2011

• Keywords provided by Anders Kvanta, Professor, St. Erik Eye Hospital: CRVO; anti-VEGF; Macular edema
• Additional relevant MeSH terms: Retinal Vein Occlusion; Bevacizumab

Study Results

No Results Posted as of Nov 22, 2011