FIREFLEYE NEXT open-label extension study (NCT04015180) to evaluate long-term outcomes of the FIREFLEYE study is active, but no longer recruiting. 96 participants were enrolled in the study worldwide including the UK. Estimated completion date is Jul 2025 .
PIII BUTTERFLEYE trial is active, but no longer recruiting. Estimated completion date is Sep 2022 
Bayer report EU filing was based on positive results from the PIII FIREFLEYE trial completed in Feb 21 at the Congress of the European Society of Retina Specialists (EURETINA). Although the study missed statistical significance for the primary endpoint of demonstrating non-inferiority of aflibercept 0.4 mg to laser (90% CI for treatment difference: −8.0% to +16.2%), the treatment success with aflibercept 0.4mg (85.5%) is considered clinically relevant. In the control group (laser surgery) a response rate of 82.1% was observed. Aflibercept was demonstrated to be efficacious, safe and well-tolerated. A PIIIb extension study, FIREFLEYE NEXT, is ongoing .
PIII Extension study to the FIREFLEYE trial started (EudraCT2018-003180-54; NCT04015180). The non-randomised, open-label PIII trial (n=100 planned) is designed to determine the binocular best-corrected visual acuity in Snellen equivalent score (at 5 years of age) and proportion of subjects with ocular or systemic AEs and is estimated to complete Jun 25 [3,4].
PIII BUTTERFLEYE trial to assess the efficacy of aflibercept compared to laser in patients diagnosed with retinopathy of prematurity (ROP) starts (NCT04101721; VGFTe-ROP1920). 112 patients will be recruited in the US, Colombia & Thailand. Primary outcome is proportion of patients with absence of active ROP and of unfavorable structural outcomes at week 52 (chronological age); collection of these data is due to complete Apr 22 .
PIII FIREFLEYE trial started (EudraCT2018-002611-99; NCT04004208). This open-label, multi-centre international RCT aims to assess the efficacy, safety, and tolerability of intravitreal (IVT) aflibercept vs laser photocoagulation in patients with Retinopathy of Prematurity (ROP). Primary outcome is proportion of patients (n=113 planned) with absence of active ROP and unfavourable structural outcomes at 24 weeks after starting treatment. Estimated primary collection date is Feb 2021 [3,4].