Overview

This trial is active, not recruiting.

Condition age related macular degeneration
Treatments ranibizumab (intravitreal injection), bevacizumab (intravitreal injection)
Phase phase 3
Sponsor Instituto de Olhos de Goiania
Start date March 2009
End date November 2009
Trial size 500 participants
Trial identifier NCT01014468, JJNJ - 8 - 2009

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Active Comparator)
Intravitreal injection of Ranibizumab (3 monthly injection followed by monthly injections as long as required)
ranibizumab (intravitreal injection)
Intravitreal injection of Ranibizumab 0.5 mg or Bevacizumab 1.25 mg (3 monthly injection followed by monthly
(Active Comparator)
Intravitreal injection of Bevacizumab (3 monthly injection followed by monthly injections as long as required)
bevacizumab (intravitreal injection)
Intravitreal injection of Ranibizumab 0.5 mg or Bevacizumab 1.25 mg (3 monthly injection followed by monthly

Primary Outcomes

Measure
Vision change Anatomical changes (Regression of NVE, CNVM, reduction in macular thickness) Electrophysiological changes (ERG, VEP )
time frame: 6 months

Secondary Outcomes

Measure
Ocular side effects (infection, RD, IOP rise, cataract)
time frame: 6 months

Eligibility Criteria

Male or female participants at least 50 years old.

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

Additional Information

Official title Comparative Study - Bevacizumab Versus Ranibizumab in 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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2011.
Information provided to ClinicalTrials.gov by Instituto de Olhos de Goiania.