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Bevacizumab Versus Ranibizumab in Age Related Macular Degeneration (AxL-2009)

Primary Purpose

Age Related Macular Degeneration

Status
Unknown status
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Ranibizumab (Intravitreal injection)
Bevacizumab (Intravitreal injection)
Sponsored by
Instituto de Olhos de Goiania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age Related Macular Degeneration focused on measuring ranibizumab, bevacizumab, AMD, Complications, Visual acuity, OCt, Age Macular Degeneration

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 50 years
  • Active primary or recurrent subfoveal lesion with CNV secondary to AMD

Exclusion Criteria:

  • 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
  • Any concurrent intraocular condition in the study eye that could either require medical or surgical intervention during the 12 month study period or that could contribute to a loss of best corrected visual acuity over the 12 months study period (e.g. diabetic retinopathy, cataract, uncontrolled glaucoma). The decision on exclusion is to be based on the opinion of the local principal investigator.
  • Active intraocular inflammation
  • Vitreous hemorrhage in the study eye

Sites / Locations

  • Instituto de Olhos de Goiânia

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Ranibizumab

Bevacizumab

Arm Description

Intravitreal injection of Ranibizumab (3 monthly injection followed by monthly injections as long as required)

Intravitreal injection of Bevacizumab (3 monthly injection followed by monthly injections as long as required)

Outcomes

Primary Outcome Measures

Vision change Anatomical changes (Regression of NVE, CNVM, reduction in macular thickness) Electrophysiological changes (ERG, VEP )

Secondary Outcome Measures

Ocular side effects (infection, RD, IOP rise, cataract)

Full Information

First Posted
November 16, 2009
Last Updated
November 19, 2011
Sponsor
Instituto de Olhos de Goiania
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1. Study Identification

Unique Protocol Identification Number
NCT01014468
Brief Title
Bevacizumab Versus Ranibizumab in Age Related Macular Degeneration
Acronym
AxL-2009
Official Title
Comparative Study - Bevacizumab Versus Ranibizumab in Age Related Macular Degeneration
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Unknown status
Study Start Date
March 2009 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
February 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto de Olhos de Goiania

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
We conducted a retrospective study of 500 eyes with choroidal neovascularization secondary to age-related macular degeneration who were treated with at least two (initial and one month after) intravitreal injection of 1.25 mg bevacizumab or 0.5 mg ranibizumab and had a follow-up of at least 3 months. Patients underwent Snellen visual acuity testing, optical coherence tomography (OCT) imaging and ophthalmoscopic examination at baseline and follow-up visits.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age Related Macular Degeneration
Keywords
ranibizumab, bevacizumab, AMD, Complications, Visual acuity, OCt, Age Macular Degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ranibizumab
Arm Type
Active Comparator
Arm Description
Intravitreal injection of Ranibizumab (3 monthly injection followed by monthly injections as long as required)
Arm Title
Bevacizumab
Arm Type
Active Comparator
Arm Description
Intravitreal injection of Bevacizumab (3 monthly injection followed by monthly injections as long as required)
Intervention Type
Drug
Intervention Name(s)
Ranibizumab (Intravitreal injection)
Intervention Description
Intravitreal injection of Ranibizumab 0.5 mg or Bevacizumab 1.25 mg (3 monthly injection followed by monthly
Intervention Type
Drug
Intervention Name(s)
Bevacizumab (Intravitreal injection)
Intervention Description
Intravitreal injection of Ranibizumab 0.5 mg or Bevacizumab 1.25 mg (3 monthly injection followed by monthly
Primary Outcome Measure Information:
Title
Vision change Anatomical changes (Regression of NVE, CNVM, reduction in macular thickness) Electrophysiological changes (ERG, VEP )
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Ocular side effects (infection, RD, IOP rise, cataract)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 50 years Active primary or recurrent subfoveal lesion with CNV secondary to AMD Exclusion Criteria: 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 Any concurrent intraocular condition in the study eye that could either require medical or surgical intervention during the 12 month study period or that could contribute to a loss of best corrected visual acuity over the 12 months study period (e.g. diabetic retinopathy, cataract, uncontrolled glaucoma). The decision on exclusion is to be based on the opinion of the local principal investigator. Active intraocular inflammation Vitreous hemorrhage in the study eye
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
João J Nassaralla, Jr
Organizational Affiliation
IOG and UnB
Official's Role
Study Chair
Facility Information:
Facility Name
Instituto de Olhos de Goiânia
City
Goiânia
State/Province
Goiás
ZIP/Postal Code
74110-120
Country
Brazil

12. IPD Sharing Statement

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Bevacizumab Versus Ranibizumab in Age Related Macular Degeneration

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