Status:
COMPLETED
Efficacy Study of Ranibizumab on Patients With Age-related Macular Degeneration.
Lead Sponsor:
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
Collaborating Sponsors:
Novartis Pharmaceuticals
University Medical Center Goettingen
Conditions:
Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE4
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01831947
Start Date
April 1 2010
End Date
March 1 2013
Last Update
April 15 2013
Active Locations (1)
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1
Dept. of Ophthalmology, University Medical Center Goettingen
Göttingen, Germany, 37075