Background Razumab™ (world’s first biosimilar ranibizumab) is approved for several macular disorders including wet age-related macular degeneration (AMD). We evaluated the safety and efficacy of biosimilar ranibizumab in wet AMD. Methods This prospective, multicentre, rAnibizumab bioSimilar Safety Efficacy postmarkeTing (ASSET) study enrolled patients aged ≥ 50 years with wet AMD having best-corrected visual acuity (BCVA) between 20/40 and 20/320. The patients received intravitreal biosimilar ranibizumab 0.5 mg every 4 weeks for 24 weeks. Safety endpoints included the incidence of adverse events (AEs), serious AEs (SAEs), and immunoreactivity after 6 months. The efficacy endpoints were the proportion of patients who lose fewer than 15 letters, increase in BCVA, change in central retinal thickness (CRT), and change in Visual Function Questionnaire-25 (VFQ-25) score, from baseline to 24 weeks. Results Of the 126 enrolled patients, majority (95.24%) of the patients received all 6 doses of biosimilar ranibizumab (total 3 mg). Nineteen AEs were reported (n = 16; 12.7%); majority (78.9%) were mild. There were no serious AEs reported, except one AE of death which was unrelated to the study drug. None of the patients discontinued the study due to an AE. The most common ocular AE was increase in intraocular pressure (4 events) and non-ocular AE was pyrexia (5 events). A total of 7.9% (10/126) patients prior to dosing and 7.1% (9/126) patients post-treatment were positive for anti-ranibizumab antibodies. No AEs suggestive of immunogenicity were noted. At 24-weeks, 97.60% patients in the intent-to-treat (ITT) population (N = 125) and 97.41% patients in the per-protocol (PP) population (N = 116) lost < 15 letters from baseline visual acuity. In the ITT and PP populations, 31.20% and 32.76% patients, respectively, showed improved visual acuity by ≥ 15 letters. Significant improvements in BCVA (mean difference: 8.8, 9.2, p < 0.001 for ITT, PP) and VFQ-25 (8.5, 9.2, p < 0.001 for ITT, PP) were seen; CRT reduced significantly (125 µm, 119.3 µm, p < 0.001 for ITT, PP). Conclusion Razumab™ (world’s first biosimilar ranibizumab) was well-tolerated without new safety concerns and significantly improved visual acuity in wet AMD patients. Trial registration CTRI/2016/03/006739. Registered 18 March 2016—Prospectively registered, http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=13141&EncHid=&userName=2016/03/006739
This article has been removed: please see Elsevier Policy on Article Withdrawal (https://www.elsevier.com/about/our-business/policies/article-withdrawal) This meeting abstract has been removed by the Publisher. Due to an administrative error, abstracts that were not presented at the ISDN 2014 meeting were inadvertently published in the meeting's abstract supplement. The Publisher apologizes to the authors and readers for this error.
Introduction: MPV and PDW are indicators of subclinical platelet hyperactivity and can be used as predictive factors for development and progression of diabetic retinopathy. Materials and Methods: This prospective case control study enrolled 150 patients with diabetic retinopathy (DR group) and 150 diabetic patients without retinopathy (control group). Detailed history and ophthalmic examination was done. The DR group was divided into 5 subgroups according to the ETDRS classification of diabetic retinopathy. MPV, PDW, FBS and PPBS values were obtained. Result: The mean value of MPV in DR group was higher compared to control group (p=0.016). PDW also followed the similar trend with DR group having mean value of 13.71± 1.36 fl and control group having 12.13 ± 1.29 fl (p=0.023). The study also found a trend of increase in severity of diabetic retinopathy with increasing level of MPV and PDW. However a statistically significant association was found only between MPV and stage of diabetic retinopathy (r= 0.214, p= 0.046). A marked increase in MPV and PDW values were found in those with Proliferative diabetic retinopathy (p<0.001). A significant correlation was found between MPV and PDW and poor glycemic control. No correlation was found between MPV and PDW and duration of diabetes. Conclusion: Platelet indices like MPV can be a cheap and easy to measure tool for monitoring diabetic retinopathy.
BACKGROUND:Retinal Vein Occlusion(RVO) is a multifactorial, with many systemic and ocular risk factors.The incidence of RVO has increased with increased life expectancy and increased incidence of risk factors. AIM:This study was done to determine the demographic characteristics and risk factors in a tertiary care hospital in South India. METHODS:100 consecutive newly diagnosed cases of RVO were included in the study. A detailed history, complete ophthalmic examination and systemic evaluation was done. RESULTS: The majority of the patients were aged more than 60 years(55%) with male preponderance(54%).The study also found that RVO was strongly associated with increasing age.Hypertension,dyslipidemia,diabetes mellitus,smoking and hyperhomocysteinemia were important systemic risk factors.Glaucoma was an important ocular risk factor.BRVO is the most common type of RVO. CONCLUSION:RVO is associated with many systemic and ocular diseases.Identifying and managing these risk factors help in preventing a second attack in either eye and thereby the visual morbidity.
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