Abstract
BackgroundThere is very limited evidence examining serious systemic adverse events (SSAEs) and post-injection endophthalmitis of intravitreal bevacizumab (IVB) and intravitreal ranibizumab (IVR) treatments in Thailand and low- and middle-income countries. Moreover, findings from the existing trials might have limited generalizability to certain populations and rare SSAEs.ObjectivesThis prospective observational study aimed to assess and compare the safety profiles of IVB and IVR in patients with retinal diseases in Thailand.MethodsBetween 2013 and 2015, 6354 patients eligible for IVB or IVR were recruited from eight hospitals. Main outcomes measures were prevalence and risk of SSAEs, mortality, and endophthalmitis during the 6-month follow-up period.ResultsIn the IVB and IVR groups, 94 and 6% of patients participated, respectively. The rates of outcomes in the IVB group were slightly greater than in the IVR group. All-cause mortality rates in the IVB and IVR groups were 1.10 and 0.53%, respectively. Prevalence rates of endophthalmitis and non-fatal strokes in the IVB group were 0.04% of 16,421 injections and 0.27% of 5975 patients, respectively, whereas none of these events were identified in the IVR group. There were no differences between the two groups in the risks of mortality, arteriothrombotic events (ATE), and non-fatal heart failure (HF). Adjustment for potential confounding factors and selection bias using multivariable models for time-to-event outcomes and propensity scores did not alter the results.ConclusionsThe rates of SAEs in both groups were low. The IVB and IVR treatments were not associated with significant risks of mortality, ATE, and non-fatal HF.Trial RegistrationThai Clinical Trial Registry identifier TCTR20141002001.Electronic supplementary materialThe online version of this article (10.1007/s40261-018-0678-5) contains supplementary material, which is available to authorized users.
Highlights
Many retinal diseases are leading causes of visual disability worldwide [1, 2]
We found that the intravitreal bevacizumab (IVB) treatment did not significantly increase the risks of all-cause mortality, arteriothrombotic events (ATE), and non-fatal heart failure (HF) compared with the intravitreal ranibizumab (IVR) treatment
The results demonstrated that both IVB and IVR have been used for neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME), and for non-FDA approved indications in routine practice; IVR was likely to be prescribed according to FDA-approved indications
Summary
Many retinal diseases are leading causes of visual disability worldwide [1, 2]. The global pooled prevalence estimates derived from population-based studies for age-related macular degeneration (AMD), diabetic macular edema (DME), and retinal vein occlusion (RVO) were 8.69% of people aged 30–97 years [3], 7.48% of diabetic patients aged 20–79 years [4], and 0.52% of people worldwide [5], respectively. Findings from the existing trials might have limited generalizability to certain populations and rare SSAEs. Objectives This prospective observational study aimed to assess and compare the safety profiles of IVB and IVR in patients with retinal diseases in Thailand. All-cause mortality rates in the IVB and IVR groups were 1.10 and 0.53%, respectively. Prevalence rates of endophthalmitis and non-fatal strokes in the IVB group were 0.04% of 16,421 injections and 0.27% of 5975 patients, respectively, whereas none of these events were identified in the IVR group. There were no differences between the two groups in the risks of mortality, arteriothrombotic events (ATE), and non-fatal heart failure (HF). The IVB and IVR treatments were not associated with significant risks of mortality, ATE, and non-fatal HF.
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