The prevalence of age-related Macular degeneration in Indian Population: a systematic review

Likhar, N; Mothe, RK; Kanukula, R.; Shah, Chirag; Dang, Anh Kim

doi:10.1016/j.jval.2015.03.1041

Cited by 10 publications

(10 citation statements)

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“…In India, the prevalence of AMD ranges from 1.4 to 3.1%, with the most common demographic factor affecting the prevalence of AMD being advanced age (> 65 years) [ 5 ]. The global prevalence of any AMD within an age range of 45 to 85 years was 8.7% [ 6 ].…”

Section: Introductionmentioning

confidence: 99%

Efficacy, Safety and Immunogenicity of Sun’s Ranibizumab Biosimilar in Neovascular Age-Related Macular Degeneration: A Phase 3, Double-Blind Comparative Study

Ghosh,

Nikumbh,

Shukla

et al. 2024

Ophthalmol Ther

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Introduction The study aimed to evaluate comparability in terms of efficacy, safety and immunogenicity of Sun’s ranibizumab biosimilar with reference ranibizumab in patients with neovascular age-related macular degeneration (nAMD). Methods This prospective, randomised, double-blind, two-group, parallel-arm, multicentre, phase 3 comparative study included patients with nAMD ≥ 50 years, randomised (in a 2:1 ratio) in a double-blind manner to receive 0.5 mg (0.05 mL) intravitreal injection of either Sun’s ranibizumab or reference ranibizumab in the study eye every 4 weeks until week 16 (total of four doses). Results Primary endpoint results demonstrated equivalence in the proportion of patients who lost fewer than 15 letters from baseline best-corrected visual acuity (BCVA) to the end of week 16 (99% of patients in Sun’s ranibizumab and 100% in reference ranibizumab; p > 0.9999), with the proportional difference (90% confidence interval) at −1% (−2.51, +0.61) lying within a pre-specified equivalence margin. Visual acuity improved by 15 or more letters in 43% of Sun’s ranibizumab group and 37% of the reference ranibizumab group ( p = 0.4267). The mean increase in BCVA was 15.7 letters in Sun’s ranibizumab group and 14.6 letters in the reference ranibizumab group ( p < 0.001 within both groups and p = 0.5275 between groups). The mean change in central macular thickness was comparable between groups ( p = 0.7946). Anti-ranibizumab antibodies were found in one patient of the reference ranibizumab group, while neutralising antibodies were not found in any patients. Both products were well tolerated. Conclusion Sun’s ranibizumab biosimilar is found to be therapeutically equivalent to reference ranibizumab in patients with nAMD. There were no additional safety or immunogenicity concerns. Trial Registration CTRI/2020/09/027629, registered on 07 September 2020. Supplementary Information The online version contains supplementary material available at 10.1007/s40123-024-00883-5.

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Section: Introductionmentioning

confidence: 99%

Efficacy, Safety and Immunogenicity of Sun’s Ranibizumab Biosimilar in Neovascular Age-Related Macular Degeneration: A Phase 3, Double-Blind Comparative Study

Ghosh,

Nikumbh,

Shukla

et al. 2024

Ophthalmol Ther

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“…Neovascular vessels proliferate underneath the retinal pigment epithelium, and leakage from these vessels leads to retinal elevation resulting in blurring of vision [ 2 , 3 ]. In India, the prevalence of AMD is estimated between 1.4% and 3.1% with advanced age (> 65 years) being the most common factor affecting the prevalence of AMD [ 4 ]. The global prevalence of AMD is estimated at ~ 8.7% [ 5 ].…”

Section: Introductionmentioning

confidence: 99%

Safety and efficacy of Razumab™ (world’s first biosimilar ranibizumab) in wet age-related macular degeneration: a post-marketing, prospective ASSET study

Sharma

Gupta

Maiti³

et al. 2021

Int J Retin Vitr

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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

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“…It is also found that the ailment affects more females (2.5%) than males (1.9%) in the age group above 65. 2 In this study, we propose an innovative approach to create a model to enhance drusen features in retinal fundus images. The approach is trustable to a higher degree by validating on two databases.…”

Section: Introductionmentioning

confidence: 99%

Fuzzy Based Combinatorial Filter Model for Drusen Enhancement in Retinal Fundus Images

2019

ijrte

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This article presents an approach to enhance drusen regions in retinal fundus image of a patient having Age-related Macular Degeneration (AMD). In this approach, a new filter model is developed by combining two processes on images which is named as Combinatorial Filter Model (CFM). The first process is based on processing drusen significant image bit planes and the second process is based on implementing fuzzy inference system (FIS) on bit planes. When bit planes are independently processed, the result improves the visibility of drusen features. An FIS is constructed to process the bit planes to further enhance the processed image. This approach is tested on images with drusen features on good quality images in proprietary database and comparatively low quality images from STARE database. The objective study of this model shows that drusen elements are enhanced and validated to a 95% significant level. The quality of the enhanced image is evaluated for preservation of drusen features using a proven feature similarity index technique with 0.99 quality index values

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The prevalence of age-related Macular degeneration in Indian Population: a systematic review

Cited by 10 publications

References 0 publications

Efficacy, Safety and Immunogenicity of Sun’s Ranibizumab Biosimilar in Neovascular Age-Related Macular Degeneration: A Phase 3, Double-Blind Comparative Study

Efficacy, Safety and Immunogenicity of Sun’s Ranibizumab Biosimilar in Neovascular Age-Related Macular Degeneration: A Phase 3, Double-Blind Comparative Study

Safety and efficacy of Razumab™ (world’s first biosimilar ranibizumab) in wet age-related macular degeneration: a post-marketing, prospective ASSET study

Fuzzy Based Combinatorial Filter Model for Drusen Enhancement in Retinal Fundus Images

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