This study is designed as an exploratory study to assess safety and efficacy of two different doses of the anti-VEGF agent ranibizumab (0.12 mg vs. 0.20 mg) in the treatment of infants with retinopathy of prematurity. Furthermore it shall help to improve safety in the treatment of ROP and provide explorative data on long-term effects of ranibizumab after intravitreal injection in neonates. The primary objective is to assess clinical efficacy of ranibizumab in children with ROP
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
19
University Eye Hospital
Freiburg im Breisgau, Baden-Wurttemberg, Germany
University Eye Hospital
Bonn, Germany
University Eye Hospital
Düsseldorf, Germany
University Eye Hospital
Kiel, Germany
Efficacy of treatment
Efficacy is determined by the number of infants without need for rescue treatment up to week 24 post first injection. Re-injection of study dose is not considered rescue treatment if applied after an initial response to treatment and after at least 4 weeks post injection.
Time frame: Up to 24 weeks post first injection
Regression of plus disease
Time frame: Up to 24 weeks post first injection
Regression of preretinal vascularized ridge
Time frame: Up to 24 weeks post first injection
Progression of peripheral intraretinal vascularization beyond ridge
Time frame: Up to 24 weeks post first injection
Number and kind of AEs and SAEs
Time frame: Up to 24 weeks post first injection
Changes in vascular endothelial growth factor (VEGF) levels in the systemic circulation
Time frame: Up to 24 weeks post first injection
Number of re-injections of study dose
Time frame: Up to 24 weeks post first injection
Number of patients progressing to stage 4 or 5 ROP
Time frame: Up to 24 weeks post first injection
Number of patients with complete vascularization of the peripheral retina to within one disc diameter of the ora serrata
Time frame: Up to 24 weeks post first injection
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