Scheduled versus Pro Re Nata Dosing in the VIEW Trials

Area of Science:

• Ophthalmology
• Retinal Diseases
• Clinical Trials

Background:

• Neovascular age-related macular degeneration (AMD) is a leading cause of vision loss.
• The VIEW studies evaluated intravitreal treatments for AMD.
• Treatment regimens often involve adjustments over time.

Purpose of the Study:

• To analyze visual acuity (VA) outcomes before and after a preplanned treatment regimen change at week 52 (W52) in the VIEW studies.
• To identify potential subgroups experiencing different outcomes post-regimen change.

Main Methods:

• Post hoc analyses of 2,457 neovascular AMD patients from two multicenter, multinational, double-masked trials.
• Patients received ranibizumab or aflibercept with varying dosing schedules up to W52, followed by a capped pro re nata (PRN) regimen until W96.
• Best-corrected VA (BCVA) and optical coherence tomography were assessed throughout.

Main Results:

• Approximately 20% of patients lost 5 or more Early Treatment Diabetic Retinopathy Study (ETDRS) letters after W52 with PRN treatment.
• Patients experiencing significant vision loss early in the PRN phase did not recover vision.
• No significant differences in serious ocular adverse events or arterial thromboembolic events were observed between groups.

Conclusions:

• A subgroup of patients showed less stable VA outcomes in the second year of the VIEW studies.
• Week 52, marking a treatment regimen switch, appears to be an important inflection point for VA outcomes.
• The change in treatment regimen at W52 is a plausible explanation for observed outcome variations.