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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Instituto de Olhos de Goiania.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Joao Nassaralla, Instituto de Olhos de Goiania
ClinicalTrials.gov Identifier:
NCT01014468
First received: November 16, 2009
Last updated: November 19, 2011
Last verified: November 2011

November 16, 2009
November 19, 2011
March 2009
November 2009   (final data collection date for primary outcome measure)
Vision change Anatomical changes (Regression of NVE, CNVM, reduction in macular thickness) Electrophysiological changes (ERG, VEP ) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01014468 on ClinicalTrials.gov Archive Site
Ocular side effects (infection, RD, IOP rise, cataract) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Bevacizumab Versus Ranibizumab in Age Related Macular Degeneration
Comparative Study - Bevacizumab Versus Ranibizumab in Age Related Macular Degeneration

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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Age Related Macular Degeneration
  • Drug: Ranibizumab (Intravitreal injection)
    Intravitreal injection of Ranibizumab 0.5 mg or Bevacizumab 1.25 mg (3 monthly injection followed by monthly
  • Drug: Bevacizumab (Intravitreal injection)
    Intravitreal injection of Ranibizumab 0.5 mg or Bevacizumab 1.25 mg (3 monthly injection followed by monthly
  • Active Comparator: Ranibizumab
    Intravitreal injection of Ranibizumab (3 monthly injection followed by monthly injections as long as required)
    Intervention: Drug: Ranibizumab (Intravitreal injection)
  • Active Comparator: Bevacizumab
    Intravitreal injection of Bevacizumab (3 monthly injection followed by monthly injections as long as required)
    Intervention: Drug: Bevacizumab (Intravitreal injection)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
500
February 2012
November 2009   (final data collection date for primary outcome measure)

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
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01014468
JJNJ - 8 - 2009
Yes
Joao Nassaralla, Instituto de Olhos de Goiania
Instituto de Olhos de Goiania
Not Provided
Study Chair: João J Nassaralla, Jr IOG and UnB
Instituto de Olhos de Goiania
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP