Clinical trial NCT01014468: Bevacizumab Versus Ranibizumab in Age Related Macular Degeneration
Official title: Comparative Study - Bevacizumab Versus Ranibizumab in Age Related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Age Related Macular Degeneration
Keywords: ranibizumab
bevacizumab
AMD
Complications
Visual acuity
OCt
Age Macular Degeneration
Lead sponsor: Instituto de Olhos de Goiania
Sponsor class: OTHER
First posted: 2009-11-17
Enrollment: 500
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Vision change Anatomical changes (Regression of NVE, CNVM, reduction in macular thickness) Electrophysiological changes (ERG, VEP )
timeFrame: 6 months
Secondary outcomes:
measure: Ocular side effects (infection, RD, IOP rise, cataract)
timeFrame: 6 months
Other outcomes:
Locations:
city: Goiânia
country: Brazil
facility: Instituto de Olhos de Goiânia
state: Goiás
Study officials:
affiliation: IOG and UnB
name: João J Nassaralla, Jr
role: STUDY_CHAIR
References: