Researchers at the Sydney Institute of Vision Science, in New South Wales, Australia report that good long-term efficacy of anti-VEGF therapy over 5 years provides a real-world setting, albeit different to the outcome data reported from clinical trial publications. In follow-up to real-world 5-year outcome data on a retrospective population, the results indicate that a mean change in visual acuity (VA) was +9.6 ± 21.6 letters among CRVO (central retinal vein occlusions) eyes and +14.2 ± 15.6 letters among eyes with BRVO (branch retinal vein occlusions)(p=0.001). The proportion of eyes with a three-line improvement of vision (15 letters) at 5 years was 22 % and this compares to clinical trial data reported in the literature.
As established, RVO (retinal vein occlusions) is generally classified into two primary categories depending on the location of obstruction: CRVO involving the entire central retinal vein, while BRVO is when only one branch of the central vein is affected. Alternatively, hemi-RVO (HRVO) may be either as a subtype of CRVO involving with the anterior part of the central retinal vein or a BRVO as the first branch of the central retinal vein. Anti-VEGF studies to treat RVO have provided several clinical trial data, usually reporting an over 12-month duration including COPERNICUS, GALILEO, BRAVO, CRUISE and VIBRANT. These studies generally use intravitreal (IVT) injections of VEGF inhibitors such as bevacizumab, ranibizumab and aflibercept however, there is limited data available over long term outcomes in a real-world setting. As commented from the Australian research study, “patients in clinical trials tend to be healthier and younger and need to be able to commit to the rigorous schedule of the clinical trial”. Consequently, it is important to assess how treatments for anti-VEGF outcomes can compare against longer duration for treatment (>5 years) and potentially compared in a heterogenous population.
Idealised patients recruited into clinical trials have found >15 letter ETDRS treatment improvements after 1 year range between 53% to 60% (VIBRANT: 52.7%; COPERNICUS: 56% and GALILEO: 60%). Alternatively, real-world data for 5 years on outcomes across a retrospective cohort show a 22% gain of ≥15 ETDRS letters. It is not unusual to see clinical trial data gains among heathier patients, especially when a rigorous controlled study and other inclusion and exclusion criteria could also show higher gains. Notwithstanding, the current 5-year analysis provides the significant benefit to help us understand how anti-VEGF medications can operate in real-world conditions. Broader studies may additionally demonstrate further activities across other jurisdictions for larger numbers and up to 10 year outcomes.