A Phase 4 interventional study of Ranibizumab in Macular Degeneration, sponsored by Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH. Completed at 1 site in Germany. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2013-04-15.
Sponsored by Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH · Phase 4, Interventional, and Treatment
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.
1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.
This study's enrollment of 40 is below the median of 51 across 985 interventional studies indexed under Macular Degeneration.
Browse Macular Degeneration studies →Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH is the lead sponsor of 14 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Injection of 0.5 mg Ranibizumab every 2 months for one year, following a monthly injection during the first 3 months.
Biological: Ranibizumab
Injection of 0.5 mg Ranibizumab on demand for one year, following a monthly injection during the first 3 months.
Biological: Ranibizumab
Also known as: Lucentis (Novartis Pharma)
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
This study is completed, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.
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Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH