AxL-2009: Bevacizumab Versus Ranibizumab in Age Related Macular Degeneration

Sponsor

Instituto de Olhos de Goiania (Other)

Overall Status

Unknown status

CT.gov ID

NCT01014468

Collaborator

(none)

500

Enrollment

Location

Arms

35.1

Duration (Months)

14.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Age Related Macular Degeneration	Drug: Ranibizumab (Intravitreal injection) Drug: Bevacizumab (Intravitreal injection)	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

500 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Comparative Study - Bevacizumab Versus Ranibizumab in Age Related Macular Degeneration

Study Start Date :

Mar 1, 2009

Actual Primary Completion Date :

Nov 1, 2009

Anticipated Study Completion Date :

Feb 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Ranibizumab Intravitreal injection of Ranibizumab (3 monthly injection followed by monthly injections as long as required)	Drug: Ranibizumab (Intravitreal injection) Intravitreal injection of Ranibizumab 0.5 mg or Bevacizumab 1.25 mg (3 monthly injection followed by monthly
Active Comparator: Bevacizumab Intravitreal injection of Bevacizumab (3 monthly injection followed by monthly injections as long as required)	Drug: Bevacizumab (Intravitreal injection) Intravitreal injection of Ranibizumab 0.5 mg or Bevacizumab 1.25 mg (3 monthly injection followed by monthly

Arm

Intervention/Treatment

Active Comparator: Ranibizumab

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

Drug: Ranibizumab (Intravitreal injection)

Intravitreal injection of Ranibizumab 0.5 mg or Bevacizumab 1.25 mg (3 monthly injection followed by monthly

Active Comparator: Bevacizumab

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

Drug: Bevacizumab (Intravitreal injection)

Intravitreal injection of Ranibizumab 0.5 mg or Bevacizumab 1.25 mg (3 monthly injection followed by monthly

Outcome Measures

Primary Outcome Measures

Vision change Anatomical changes (Regression of NVE, CNVM, reduction in macular thickness) Electrophysiological changes (ERG, VEP ) [6 months]

Secondary Outcome Measures

Ocular side effects (infection, RD, IOP rise, cataract) [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts 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