Real-world safety of intravitreal bevacizumab and ranibizumab treatments for retinal diseases in Thailand: a prospective observational study

Background: There 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. Objectives: This prospective observational study aimed to assess and compare the safety profiles of IVB and IVR in patients with retinal diseases in Thailand. Methods: Between 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. Results: In 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. Conclusions: The 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 Registration: Thai Clinical Trial Registry identifier TCTR20141002001

Is the 2015 eye care service delivery profile in Southeast Asia closer to universal eye health need!

Purpose: The year 2015 status of eye care service profile in Southeast Asia countries was compared with year 2010 data to determine the state of preparedness to achieve the World Health Organization global action plan 2019. Methods: Information was collected from the International Agency for Prevention of Blindness country chairs and from the recent PubMed referenced articles. The data included the following: blindness and low vision prevalence, national eye health policy, eye health expenses, presence of international non-governmental organizations, density of eye health personnel, and the cataract surgical rate and coverage. The last two key parameters were compared with year 2010 data. Results: Ten of 11 country chairs shared the information, and 28 PubMed referenced publications were assessed. The prevalence of blindness was lowest in Bhutan and highest in Timor-Leste. Cataract surgical rate was high in India and Sri Lanka. Cataract surgical coverage was high in Thailand and Sri Lanka. Despite increase in number of ophthalmologists in all countries (except Timor-Leste), the ratio of the population was adequate (1:100,000) only in 4 of 10 countries (Bhutan, India, Maldives and Thailand), but this did not benefit much due to unequal urban-rural divide. Conclusion: The midterm assessment suggests that all countries must design the current programs to effectively address both current and emerging causes of blindness. Capacity building and proportionate distribution of human resources for adequate rural reach along with poverty alleviation could be the keys to achieve the universal eye health by 2019. Keywords: Eye care delivery; Southeast Asia; Universal eye health

Classification of Choroidal Neovascularization by Digital Indocyanine Green Videoangiography

Purpose: The majority of patients with exudative maculopathy due to age-related macular degeneration present with poorly defined or occult choroidal neovascularization (CNV) that cannot be imaged adequately by fluorescein angiography. Digital indocyanine green (ICG) videoangiography is a new technique that allows enhanced imaging of these poorly defined or occult vessels. The authors studied 1000 consecutive cases of occult CNV using digital ICG angiography to describe the various types of neovascularization observed by this technique and to determine the frequency and natural history of the various lesions. Materials and Methods: Digital ICG videoangiography was performed as described previously on 1000 consecutive eyes with occult CNV by fluorescein angiography. Results: One thousand consecutive eyes with occult CNV by fluorescein angiography were imaged using digital ICG videoangiography. Three morphologic types of CNV were noted by ICG videoangiography, which included focal spots, plaques (well-defined or poorly defined), and combination lesions (in which both focal spots and plaques are noted). Combination lesions can be subdivided into marginal spots (focal spots at the edge of plaques of neovascularization), overlying spots (hot spots overlying plaques of neovascularization), or remote spots (a focal spot remote from a plaque of neovascularization). The relative frequency of these lesions was as follows: there were 283 cases (29%) of focal spots; 597 cases (61 %) of plaques, consisting of 265 cases (27%) of well-defined plaques and 332 cases (34%) of poorly defined plaques; and 84 cases (8%) of combination lesions, consisting of 35 cases (3%) of marginal spots, 37 cases (4%) of overlying spots, and 12 cases (1 %) of remote spots. In seven additional cases (1 %), a mixture of the above lesions was noted. In 13 additional eyes (1%), no lesions were noted on the ICG angiogram. The studies of 16 eyes were unreadable or unobtainable. Conclusions: There are three types of CNV that can be observed by digital ICG videoangiography. Plaques are the most common type and have a poor natural history. Focal spots or hot spots are the next most frequently seen lesion and can potentially be treated by ICG-guided laser photocoagulation. Combination lesions, in which both focal spots and plaques are present, are rare. This study of 1000 consecutive cases of eyes with occult neovascularization that were imaged with digital ICG vc~eoangiography serves to classify the various types of neovascularization observed by this technique. Digital ICG videoangiography is an important tool in better delineating eyes with occult CNV. Future studies are necessary to validate our findings

A real-world study of effectiveness of intravitreal bevacizumab and ranibizumab injection for treating retinal diseases in Thailand

Abstract Background To evaluate the effectiveness of intravitreal bevacizumab (IVB) and intravitreal ranibizumab (IVR) in actual practice for treating patients with retinal diseases in Thailand. Methods A prospective, multi-centre, observational study was conducted among eight hospitals in their ophthalmology outpatient departments. Participants consisted of patients who had previously not received any IVB or IVR treatment between 2013 and 2014. The primary outcome measurement was the change in best-corrected visual acuity (BCVA) at the end of the follow-up period compared to baseline. Results There were 1629 treatment-naïve patients for the pro re nata (PRN) treatment pattern and 226 treatment-naive patients for the three-injections (3Inj) treatment pattern. BCVA improvements were found in 35% of the PRN group and 47% of the 3Inj group; however, it was not clinically meaningful between the IVB and IVR groups (P-value = 0.568 for PRN, P-value = 0.103 for 3Inj). A multivariable logistic regression (using the propensity score) showed that positive factors associated with vision improvement for the PRN pattern were the number of drug injections, having retinal vein occlusion, and under 60 years of age, while good BCVA at baseline was a negative predictive factor. For the 3Inj pattern, under 60 years of age and baseline BCVA were statistically significant predictors. Nonetheless, diabetes mellitus (DM) without other comorbidities was a statistically significant predictor of low response to vision improvement compared to DM with other comorbidities. Conclusions This study was the first observational, prospective study to evaluate the real-life effectiveness of IVB and IVR in Thailand. The majority of participants who used IVB or IVR showed improvements in BCVA after treatment. Further evaluation such as long-term follow-ups and subsequent comparison of effectiveness between IVB and IVR should be investigated due to the limited sample of IVR patients. Trial registration Thai Clinical Trial Registry TCTR20141002001. Registered 02 October 2014 (retrospectively registered)