Bevacizumab Versus Ranibizumab in Age Related Macular Degeneration

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparative Study - Bevacizumab Versus Ranibizumab in Age Related Macular Degeneration

Conditions
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Age Related Macular Degeneration

Intervention / Treatment
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* Drug: Ranibizumab (Intravitreal injection)
* Drug: Bevacizumab (Intravitreal injection)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ranibizumab<br>Intravitreal injection of Ranibizumab (3 monthly injection followed by monthly injections as long as required) | Drug: Ranibizumab (Intravitreal injection)<br>* Intravitreal injection of Ranibizumab 0.5 mg or Bevacizumab 1.25 mg (3 monthly injection followed by monthly<br>|
| Active Comparator: Bevacizumab<br>Intravitreal injection of Bevacizumab (3 monthly injection followed by monthly injections as long as required) | Drug: Bevacizumab (Intravitreal injection)<br>* Intravitreal injection of Ranibizumab 0.5 mg or Bevacizumab 1.25 mg (3 monthly injection followed by monthly<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vision change Anatomical changes (Regression of NVE, CNVM, reduction in macular thickness) Electrophysiological changes (ERG, VEP ) |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular side effects (infection, RD, IOP rise, cataract) |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ranibizumab, bevacizumab, AMD, Complications, Visual acuity, OCt, Age Macular Degeneration