Bevacizumab Versus Ranibizumab in Age Related Macular Degeneration

Phase 3

• Conditions: Age Related Macular Degeneration
• Interventions: Drug: Ranibizumab (Intravitreal injection); Drug: Bevacizumab (Intravitreal injection)

• Registration Number: NCT01014468
• Lead Sponsor: Instituto de Olhos de Goiania

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.

Study Timeline

• Study Start: 2009-03
• Primary Completion: 2009-11
• Study First Submitted: 2009-11-16
• Study First Submitted QC: 2009-11-16
• Study First Posted: 2009-11-17
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-19
• Last Update Posted: 2011-11-22
• Study Completion: 2012-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ranibizumab	Ranibizumab (Intravitreal injection)	Intravitreal injection of Ranibizumab (3 monthly injection followed by monthly injections as long as required)
Bevacizumab	Bevacizumab (Intravitreal injection)	Intravitreal injection of Bevacizumab (3 monthly injection followed by monthly injections as long as required)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Ocular side effects (infection, RD, IOP rise, cataract)	6 months

Trial Locations

Locations (1)

Instituto de Olhos de Goiânia; 🇧🇷 Goiânia, Goiás, Brazil