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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Dept. of Ophthalmology, University Medical Center Goettingen
Göttingen, Germany
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).
Time frame: 12 months after start of treatment
Fluoresceinangiography
To study morphological and anatomical changes of the retina. Affected area is determined in mm²
Time frame: 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.
Time frame: 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.
Time frame: 12 months after treatment start
number of injections
Time frame: 12 months after treatment start
quality of life
change in quality of life
Time frame: 12 months after treatment start
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