PIII RAINBOW (n=225) study is published; it reports higher rate of treatment success (survival with no active retinopathy) with ranibizumab 0.2 mg vs. laser therapy, but this was of borderline statistical significance (80% vs. 66%; OR 2.19, 95% Cl 0.99–4.82, p=0.051) .
Novartis announced that treatment with ranibizumab did not meet the primary endpoint in the global randomised, parallel-assignment, open-label, PIII RAINBOW trial (n=300), and marginally missed statistical significance for demonstrating superiority to laser surgery. However, since 80% of patients achieved treatment success with ranibizumab vs 66% with laser, the company still plans to file outside of the US for this indication .
PIII RAINBOW trial (NCT02375971) completed .
Novartis initiates the extension study RAINBOWExt in patients who were treated for ROP in the core RAINBOW study (CRFB002H2301E1; NCT02640664). The study intends to enrol approximately 300 patients in Belgium, Estonia, Hungary, Slovakia, Italy, Lithuania, Czech Republic and Austria .
Novartis initiates the PIII RAINBOW trial to evaluate efficacy and safety of intravitreal ranibizumab compared with laser therapy for the treatment of infants born prematurely with retinopathy of prematurity (CRFB002H2301; NCT02375971). The randomised, parallel-assignment, open-label, controlled trial intends to enrol 300 patients in Austria, Belgium, Croatia, Czech Republic, Estonia, France, Slovakia, Denmark, Finland, Poland, Greece, Germany, Hungary, India, Italy, Japan, Lithuania, Turkey and the UK .