The CANDELA Study —Trends and End Points

As we progress into the next era of treatments for retinal vascular diseases, we strive to find options that have both better durability and efficacy as well as fewer visits. The bar is already high with the first generation of anti –vascular endothelial growth factor (VEGF) molecules. Wykoff et al present the results of the Safety, Tolerability, and Efficacy of Aflibercept in Patients With Neovascular Age-Related Macular Degeneration (CANDELA) study, which evaluates 8-mg aflibercept compared with 2-mg aflibercept in a fixed- dosing schedule for the treatment of neovascular age-related macular degeneration. The primary end points were safety, based on assessment of treatment-emergent adverse events and serious adverse events through week 4, and proportion of patients without retinal fluid in the central subfield at week 16. There were no prespecified secondary end points. The results showed safety, but did not meet the primary end point of absence of fluid at 16 weeks. We commend the authors for publishing these data, as often studies that do not meet their primary end point are not submitted for publication. At 16 weeks, patients in both groups had similar rates of absence of fluid in the central subfield with no statistical difference. The authors point out that the high-dose aflibercept group trended to have less intraretinal and subretinal fluid at week 16. Other exploratory outcomes, not prespecified as a secondary outcome, also trended to be favorable for the 8-mg afl...
Source: JAMA Ophthalmology - Category: Opthalmology Source Type: research