Efficacy Study of Ranibizumab on Patients With Age-related Macular Degeneration.

Study Overview
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Brief Summary
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This clinical trial investigates the impact of intravitreal injection of Ranibizumab antibody on the acuteness of vision. Patients included are suffering from choroidal neo-vascularization (CNV) as a consequence of age-related macular degeneration (AMD). Initially, all patients get injections of 0.5 mg Ranibizumab in monthly intervals for 3 months. Subsequently, one group gets Ranibizumab in intervals of 2 months, whereas a second group is treated on demand. The primary end point of the study is the change of best-corrected visual acuity after 12 month. Secondary end points include the impact of Ranibizumab on morphological changes of the retina, the number of patients with gain or loss of 15 or more letters visual acuity after 12 months, changes in quality of life and the number of injections required during the first 12 months of treatment.

Official Title
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Efficacy of Ranibizumab Treatment Every 2 Month Compared to Treatment on Demand on Patients With Choroidal Neo-vascularization (CNV) as a Consequence of Age-related Macular Degeneration (AMD)

Conditions
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Macular Degeneration

Intervention / Treatment
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* Biological: Ranibizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with choroidal neo-vascularization (CNV) as a consequence of age-related macular degeneration (AMD) age 50 and older, male and female membrane <= 12 papillary diameter visual acuity between 20/320 and 20/40 (ETDRS) written informed consent Exclusion Criteria: known hypersensitivity to the medicinal product under investigation, ingredients or medicinal products with a similar chemical structure participation in another clinical trial within the last 4 weeks unability to understand trial information pregnant or lactating women women with an amenorrhea < 12 months suspected unability to cooperate detachment of pigment epithelium without membrane detection >= 50%,retinal angiomatotic proliferation (RAP), presumed ocular histoplasmosis syndrome (POHS), chorioretinal anastomosis (CRA), myopic CNV, CNV following trauma, uveitis, RCS or reasons except AMD rupture of pigment epithelium sub-retinal bleeding >= 50% of membrane or >= 1 PD sub-retinal fibrosis or chorio-atrophy pre-treatment with Verteporfin (photodynamic therapy), radiotherapy, trans-pupillary thermotherapy of the eye under investigation as a consequence of maculadegeneration treatment with Verteporfin of the eye not under investigation within 7 days prior inclusion former participation in clinical trials with anti-angiogenic substances: Pegaptanib, Ranibizumab, Bevacizumab, Anecortave Acetat, Proteinkinase C Inhibitors former injection of anti-angiogenic substances in the eye under investigation former focal sub-foveal lasercoagulation of the eye under investigation juxta- or extra-foveal lasercoagulation of the eye under investigation within 1 month prior inclusion former vitrectomy former surgery as a consequence of maculadegeneration glaucoma patients which have been treated with prostaglandin containing eye drops other ocular diseases which may lead to surgery within the clinical study or may lead to a loss of vision of two lines acute intraocular inflammation of the eye under investigation vitreous hemorrhage of the eye under investigation macula-foramen of the eye under investigation diabetic retinopathy former retina detachment of the eye under investigation uveitis acute conjunctivitis, keratitis, scleritis, or endophthalmitis aphakia or pseudo-aphakia with damaged back-capsule(exception: YAG-capsulotomy) myopia larger than -8 diopter former intra-ocular surgery of the eye under investigation within 2 months prior inclusion de-compensated glaucoma with >= 30 mm Hg despite therapy former filtrating glaucoma surgery of the eye under investigation former corneal grafting of the eye under investigation former stroke or heart attack on-going therapy because of systemic infection known allergic reaction to fluorescein bad quality of fundus documentation because of bad range of vision

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ranibizumab fixed dose<br>Injection of 0.5 mg Ranibizumab every 2 months for one year, following a monthly injection during the first 3 months. | Biological: Ranibizumab<br> <br> * Other names: Lucentis (Novartis Pharma);|
| Experimental: Ranibizumab on demand<br>Injection of 0.5 mg Ranibizumab on demand for one year, following a monthly injection during the first 3 months. | Biological: Ranibizumab<br> <br> * Other names: Lucentis (Novartis Pharma);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| best-corrected visual acuity | Change of best-corrected visual acuity before and 12 months after start of treatment with respect to number of letters read on ETDRS-sheets (Early Treatment Diabetes Retinopathy Study Sheets). | 12 months after start of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fluoresceinangiography | To study morphological and anatomical changes of the retina. Affected area is determined in mm² | 12 months after start of treatment | 
| Photography | To study morphological and anatomical changes of the retina. Affected area is assessed by computer-assisted measurement in mm². | 12 months after treatment start | 
| optical coherence tomography (OCT) | To study morphological and anatomical changes of the retina. Thickness of the retina is determined in µm². | 12 months after treatment start | 
| number of injections |  | 12 months after treatment start | 
| quality of life | change in quality of life | 12 months after treatment start | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ranibizumab, age-related macular degeneration