Bevacizumab Versus Ranibizumab in Age Related Macular Degeneration
AxL-2009
Comparative Study - Bevacizumab Versus Ranibizumab in Age Related Macular Degeneration
1 other identifier
interventional
500
1 country
1
Brief Summary
To report the short term anatomic and visual acuity response after intravitreal injection of bevacizumab and ranibizumab in patients with choroidal neovascularization secondary to age-related macular degeneration.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2009
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 16, 2009
CompletedFirst Posted
Study publicly available on registry
November 17, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedNovember 22, 2011
November 1, 2011
8 months
November 16, 2009
November 19, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Vision change Anatomical changes (Regression of NVE, CNVM, reduction in macular thickness) Electrophysiological changes (ERG, VEP )
6 months
Secondary Outcomes (1)
Ocular side effects (infection, RD, IOP rise, cataract)
6 months
Study Arms (2)
Ranibizumab
ACTIVE COMPARATORIntravitreal injection of Ranibizumab (3 monthly injection followed by monthly injections as long as required)
Bevacizumab
ACTIVE COMPARATORIntravitreal injection of Bevacizumab (3 monthly injection followed by monthly injections as long as required)
Interventions
Intravitreal injection of Ranibizumab 0.5 mg or Bevacizumab 1.25 mg (3 monthly injection followed by monthly
Intravitreal injection of Ranibizumab 0.5 mg or Bevacizumab 1.25 mg (3 monthly injection followed by monthly
Eligibility Criteria
You may qualify if:
- Age ≥ 50 years
- Active primary or recurrent subfoveal lesion with CNV secondary to AMD
You may not qualify if:
- Prior treatment with any intravitreal drug in the study eye
- Prior treatment with verteporfin photodynamic therapy in the study eye
- Prior treatment with systemic bevacizumab
- Prior treatment with any intravitreal drug or verteporfin photodynamic therapy in the nonstudy eye within the 3 moths before the study entry
- Laser photocoagulation within 1 month before study entry in the study eye
- Previous participation in any clinical trial within 1 month before the entry of the study
- Subfoveal fibrosis or atrophy in the study eye
- CNV in either of the two eye due to causes other than AMD such as histoplasmosis or pathological myopia
- Retinal pigment epithelial tear involving the macula in the study eye
- Active intraocular inflammation
- Vitreous hemorrhage in the study eye
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Instituto de Olhos de Goiânia
Goiânia, Goiás, 74110-120, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
João J Nassaralla, Jr
IOG and UnB
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Doctor
Study Record Dates
First Submitted
November 16, 2009
First Posted
November 17, 2009
Study Start
March 1, 2009
Primary Completion
November 1, 2009
Study Completion
February 1, 2012
Last Updated
November 22, 2011
Record last verified: 2011-11