Abstract
Purpose:
To determine the incidence and causes of transient, large decreases in visual acuity (VA), which we have termed sporadic VA loss (SpVL), in neovascular age-related macular degeneration (AMD) patients treated with anti-VEGF drugs.
Methods:
Secondary analysis of 1185 study patients enrolled in the Comparison of AMD Treatments Trials (CATT). SpVL required VA data from three consecutive visits. SpVL was defined as a decline of ≥ 15 letters from the previous visit, followed by a return at the next visit to no more than 5 letters worse than the visit before the VA loss. The main outcome measures were the incidence of SpVL over 2 years of monthly visits and the odds ratio (OR) for association of SpVL with patient and ocular factors at baseline and during treatment.
Results:
During CATT, there were 146 SpVL events in 124 (10.5%) study eyes of 1185 patients. Mean VA at two years was 58.9 letters (~20/63) for those with SpVL and 68.3 letters (~20/40) for those without SpVL (P<0.001). The mean VA change from baseline was 3.2 letters for patients with SpVL compared with 6.7 letters for patients without SpVL (P = 0.03). 29.7% (30/101) of events among patients treated pro re nata (PRN) were not treated with an injection at the time of SVL. No significant associations were seen with serious adverse events. Multivariate analysis demonstrated that baseline predictors for SpVL included worse baseline VA (OR 2.82, 95% CI: 1.61-4.95 for ≤ 20/200 compared to ≥ 20/40), scar (OR 2.33, 95% CI: 1.26-4.29), and intraretinal foveal fluid on optical coherence tomography (OR 1.77, 95% CI: 1.10-2.84). Baseline medical history predictors included anxiety (OR 1.87, 95% CI: 1.10-3.19) and syncope (OR 2.69, 95% CI: 1.42-5.11). Treatment drug or regimen was not associated with SpVL (P>0.10). Refraction decreased the likelihood of SpVL (OR 0.62, 95% CI: 0.43-0.91).
Conclusions:
Approximately 11% of CATT patients had SpVL over 2 years of monthly visits. Baseline predictors of SpVL included AMD-related factors but also factors independent of AMD, such as an anxiety history, syncope history, and absence of refraction. These data should be considered when clinicians see SpVL in practice or during a clinical trial.
Keywords: 412 age-related macular degeneration •
754 visual acuity •
688 retina