Comparing the Effectiveness and Costs of Bevacizumab to Ranibizumab in Patients With Retinal Vein Occlusions (BRVO)

NCT01635803 | Unknown Phase 2 DMC

• 1 other identifier: NL35869.018.11
• Study Type: interventional
• Target: 296
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective is to demonstrate the non-inferiority of bevacizumab in the treatment of patients with macular edema secondary to a retinal vein occlusion (branch or central) as determined by the change in best-corrected visual acuity in the study eye from baseline to month 6.

Conditions

Retinal Vein Occlusion

Keywords

bevacizumab; ranibizumab; retinal vein occlusions; randomized clinical trial; Macular edema

Outcome Measures

Primary Outcomes (1)

• Best corrected visual acuity

  The primary outcome is the change in best-corrected visual acuitiy (BCVA) in the study eye from baseline to month 6 assessed with EDTRS-like VA charts at an initial distance of four meter.

  6 months

Secondary Outcomes (6)

• Proportion of patients with a gain or loss of 15 letters or more

  6 months

• Change in leakage on fluorescein angiography

  6 months

• Change in foveal thickness by optical coherence tomography

  6 months

• The number of adverse events

  6 months

• Costs per quality adjusted life-year of the two treatments

  6 months

Study Arms (2)

Ranibizumab

ACTIVE COMPARATOR

Monthly injections with ranibizumab during 6 months

Drug: Ranibizumab

Bevacizumab

ACTIVE COMPARATOR

Monthly injections with bevacizumab during 6 months

Drug: Bevacizumab

Interventions

Bevacizumab DRUG

1.25 mg bevacizumab administered by monthly interval for six months (6 injections).

Also known as: Avastin

Bevacizumab

Ranibizumab DRUG

0.5mg ranibizumab administered by monthly interval for six months (6 injections).

Also known as: Lucentis

Ranibizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients \> 18 years of age with vision loss due to foveal center-involved ME secondary to branch or central retinal vein occlusion diagnosed within 6 months before study initiation, who have signed an informed consent;
• BCVA equal or more than 24 and less or equal to 78 letters in the study eye at screening using ETDRS- like visual acuity testing charts at a testing distance of 4 meters
• Mean central subfield thickness more than 275 micron on 2 OCT measurements.

You may not qualify if:

• Women of child-bearing potential.
• Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive serum pregnancy test (human chorionic gonadotropin \> 5 mIU/ml);
• Inability to comply with study procedures;
• Active intraocular inflammation in either eye at enrolment;
• Any active infection in either eye at the time of enrolment;
• History of uveitis in either eye at any time;
• Structural damage within 600 micron of the center of the macula in the study eye likely to preclude improvement in visual acuity following in the resolution of macular edema, including atrophy of the retinal pigment epithelium, subretinal fibrosis, laser scar(s), epiretinal membrane involving fovea or organized hard exudate plaques;
• Uncontrolled (neovascular) glaucoma in the study eye at screening. (IOP \> 24 mmHg on medication or according to investigator's judgment);
• Evidence of vitreomacular traction in the study eye;
• Patients who are monocular or have a Snellen VA in the non-study eye ≤ 1/300 at visit 1;
• Any intraocular surgery in the study eye within 3 months prior to randomization;
• Planned medical or surgical intervention during the 6-months study period;
• Panretinal laser photocoagulation in the study eye within 3 months prior to or during the study;
• Focal/grid laser photocoagulation in the study eye 3 months prior to study entry;
• Treatment with anti-angiogenic drugs in the study eye within 3 months prior to randomization;

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• Leiden University Medical Center: collaborator
• Free University Medical Center: collaborator
• Erasmus Medical Center: collaborator
• Radboud University Medical Center: collaborator
• UMC Utrecht: collaborator
• University Medical Center Groningen: collaborator

Study Sites (1)

Academic Medical Center, Dept. Ophthalmology

Amsterdam, 1105 AZ, Netherlands

RECRUITING

MeSH Terms

Conditions

Retinal Vein Occlusion; Macular Edema

Interventions

Bevacizumab; Ranibizumab

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Macular Degeneration; Retinal Degeneration

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Reinier O Schlingemann, MD, PhD

  Academic Medical Center, Dept. Ophthalmology, Room A2-122, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Reinier O Schlingemann, PhD, MD

CONTACT

+31 20 5663682; r.schlingemann@amc.uva.nl

Monique -- Wezel

CONTACT

+31 205663616; m.wezel@amc.uva.nl

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: June 28, 2012
• First Posted: July 10, 2012
• Study Start: June 1, 2012
• Primary Completion: June 1, 2016
• Last Updated: July 1, 2015

Record last verified: 2015-06

Locations

NL (1)