Bevacizumab Versus Ranibizumab in Age Related Macular Degeneration

Age Related Macular Degeneration Clinical Trial

— AxL-2009  

Official title:

Comparative Study - Bevacizumab Versus Ranibizumab in Age Related Macular Degeneration

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01014468
• Other study ID #: JJNJ - 8 - 2009
• Status: Active, not recruiting
• Phase: Phase 3
• First received: November 16, 2009
• Last updated: November 19, 2011
• Start date: March 2009
• Est. completion date: February 2012

Study information

• Verified date: November 2011
• Source: Instituto de Olhos de Goiania
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: February 2012
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Age Related Macular Degeneration
• Macular Degeneration

Intervention

Drug:
• Ranibizumab (Intravitreal injection)
Intravitreal injection of Ranibizumab 0.5 mg or Bevacizumab 1.25 mg (3 monthly injection followed by monthly
• Bevacizumab (Intravitreal injection)
Intravitreal injection of Ranibizumab 0.5 mg or Bevacizumab 1.25 mg (3 monthly injection followed by monthly

Locations

Country	Name	City	State
Brazil	Instituto de Olhos de Goiânia	Goiânia	Goiás

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Olhos de Goiania

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vision change Anatomical changes (Regression of NVE, CNVM, reduction in macular thickness) Electrophysiological changes (ERG, VEP )		6 months	Yes
Secondary	Ocular side effects (infection, RD, IOP rise, cataract)		6 months	Yes