BRAIN HEALTH ASSESSMENT IN MACULAR DEGENERATION PATIENTS UNDERGOING INTRAVITREAL ANTI-VASCULAR ENDOTHELIAL GROWTH FACTOR INJECTIONS (THE BHAM STUDY): An Interim Analysis.

PURPOSE: After intravitreal injection, anti-vascular endothelial growth factor (VEGF) agents are found in the systemic circulation and can suppress systemic VEGF levels. Neuronal health and cognitive function in the central nervous system have been associated with normal physiological levels of VEGF expression. We wished to determine whether there was an association between cumulative anti-VEGF exposure and cognitive function. METHODS: One hundred and seventy-five patients aged 65 to 85 with vision of at least 20/50 or better in one eye and a diagnosis of age-related macular degeneration took an iPad-based brain health assessment to determine their risk of mild cognitive impairment. The result for each patient was compared with the total number of anti-VEGF injections per individual patient. Patients were then stratified into groups with 0 injections (control), 1 to 9 injections, 10 to 20 injections, or greater than 20 injections. RESULTS: The group of patients with more than 20 injections had a higher likelihood of mild cognitive impairment compared with the control group, with statistically significant worse mean Z-scores (P = 0.04). CONCLUSION: Our study is the first to associate worsening cognitive health with higher cumulative anti-VEGF injections. This study was not designed to show a causal link, but does suggest that additional investigation is warranted.

LuceDex: a prospective study comparing ranibizumab plus dexamethasone combination therapy versus ranibizumab monotherapy for neovascular age-related macular degeneration.

BACKGROUND: The LuceDex prospective randomized pilot trial compared the combination of intravitreal ranibizumab and dexamethasone with ranibizumab monotherapy for treatment of neovascular age-related macular degeneration. METHODS: Thirty-seven eyes of 37 patients were randomized 1:1 between combination therapy with intravitreal ranibizumab and dexamethasone (Group 1) and intravitreal ranibizumab monotherapy (Group 2). All study eyes received 4 monthly treatments followed by monthly treatment on indication. RESULTS: In the LuceDex study, eyes gained an average of 11.1 and 5.9 Early Treatment of Diabetic Retinopathy Study letters in Groups 1 and 2, respectively, at Month 12. No more than zero Early Treatment of Diabetic Retinopathy Study letters were lost in 88% of Group 1 eyes and 70% of Group 2 eyes. The average number of treatments per study eye by Month 12 was 7.1 in Group 1 and 6.6 in Group 2. Choroidal neovascular membrane size decreased in Group 1 significantly compared with Group 2 (P < 0.05). CONCLUSION: The LuceDex pilot study suggested a possible benefit of adding intravitreal dexamethasone to treatment of neovascular age-related macular degeneration with intravitreal ranibizumab. A larger study is needed to further identify and define possible benefits of this combination therapy.