Raja Narayanan1, Aditya Kelkar2, Zahir Abbas3, Neha Goel4, Manoj Soman5, Naveen Naik6, Aditya Sudhalkar7, Jaydeep Walinjkar8, Utkarsh Shah9, Nitin Maksane9. 1. L V Prasad Eye Institute, Hyderabad Eye Research Foundation, Hyderabad, Telangana, India. narayanan@lvpei.org. 2. National Institute of Ophthalmology, Pune, Maharashtra, India. 3. Apollo Gleneagles Heart Centre, Kolkata, West Bengal, India. 4. ICARE Research Center, Noida, Uttar Pradesh, India. 5. Chaithanya Eye Hospital, Trivendrum, Kerala, India. 6. Narayana Nethralaya, Bengaluru, Karnataka, India. 7. Iladevi Cataract & IOL Research Centre, Ahmedabad, Gujarat, India. 8. Sankara Nethralaya, Chennai, Tamilnadu, India. 9. Novartis Healthcare Private Limited, Mumbai, Maharashtra, India.
Abstract
BACKGROUND: Macular edema secondary to retinal vein occlusion (RVO) is an important cause of loss of vision. Intravitreal injections (IVI) of anti-vascular endothelial growth factor (VEGF) are the standard of care in this disease, as shown in numerous randomized controlled trials. The purpose of this study was to study the efficacy and safety of ranibizumab, an anti-VEGF agent, in the real-world setting. METHODS: This was 48 weeks, open-label, prospective, multicentre, observational study. Patients diagnosed with ME secondary to RVO were treated with IVI of Ranibizumab 0.5 mg in real-world conditions. Efficacy was measured by improvement seen in best-corrected visual acuity (BCVA) in terms of Early Treatment of Diabetic Retinopathy Study (ETDRS) Letter Scores and change in central retinal thickness (CRT) measured by optical coherence tomography. RESULTS: One hundred eyes of 100 patients (79 with branch retinal vein occlusion and 21 with central retinal vein occlusion) were recruited in the study. The mean (standard deviation, SD) BCVA was 52.8 (21.99) letters at baseline and 62.3 (24.40) letters at week 48. From baseline, there was a significant improvement in BCVA by 7.7 letters (p = 0.001) at 48 weeks. The mean (SD) of CRT was 479.9 (216.25) μm at baseline and it decreased significantly to 284.9 (171.35) μm at week 48 (p < 0.001). During the study period, the average number of intravitreal injections was 3.5 per patient. There was no report of endophthalmitis in any eye. CONCLUSIONS: Ranibizumab is well tolerated and effective in treating macular edema secondary to RVO in real-world clinical settings. However, there is under-treatment compared to controlled clinical trials, and the gain in vision is sub-optimal with under-treatment. TRIAL REGISTRATION: Clinical Trials Registry - India: CTRI/2015/07/005985 .
BACKGROUND:Macular edema secondary to retinal vein occlusion (RVO) is an important cause of loss of vision. Intravitreal injections (IVI) of anti-vascular endothelial growth factor (VEGF) are the standard of care in this disease, as shown in numerous randomized controlled trials. The purpose of this study was to study the efficacy and safety of ranibizumab, an anti-VEGF agent, in the real-world setting. METHODS: This was 48 weeks, open-label, prospective, multicentre, observational study. Patients diagnosed with ME secondary to RVO were treated with IVI of Ranibizumab 0.5 mg in real-world conditions. Efficacy was measured by improvement seen in best-corrected visual acuity (BCVA) in terms of Early Treatment of Diabetic Retinopathy Study (ETDRS) Letter Scores and change in central retinal thickness (CRT) measured by optical coherence tomography. RESULTS: One hundred eyes of 100 patients (79 with branch retinal vein occlusion and 21 with central retinal vein occlusion) were recruited in the study. The mean (standard deviation, SD) BCVA was 52.8 (21.99) letters at baseline and 62.3 (24.40) letters at week 48. From baseline, there was a significant improvement in BCVA by 7.7 letters (p = 0.001) at 48 weeks. The mean (SD) of CRT was 479.9 (216.25) μm at baseline and it decreased significantly to 284.9 (171.35) μm at week 48 (p < 0.001). During the study period, the average number of intravitreal injections was 3.5 per patient. There was no report of endophthalmitis in any eye. CONCLUSIONS:Ranibizumab is well tolerated and effective in treating macular edema secondary to RVO in real-world clinical settings. However, there is under-treatment compared to controlled clinical trials, and the gain in vision is sub-optimal with under-treatment. TRIAL REGISTRATION: Clinical Trials Registry - India: CTRI/2015/07/005985 .
Authors: Jeffrey S Heier; W Lloyd Clark; David S Boyer; David M Brown; Robert Vitti; Alyson J Berliner; Husain Kazmi; Yu Ma; Brigitte Stemper; Oliver Zeitz; Rupert Sandbrink; Julia A Haller Journal: Ophthalmology Date: 2014-03-27 Impact factor: 12.079
Authors: Peter A Campochiaro; David M Brown; Carl C Awh; S Young Lee; Sarah Gray; Namrata Saroj; Wendy Yee Murahashi; Roman G Rubio Journal: Ophthalmology Date: 2011-06-29 Impact factor: 12.079
Authors: Peter A Campochiaro; Gulnar Hafiz; Syed Mahmood Shah; Quan Dong Nguyen; Howard Ying; Diana V Do; Edward Quinlan; Ingrid Zimmer-Galler; Julia A Haller; Sharon D Solomon; Jennifer U Sung; Yasmin Hadi; Kashif A Janjua; Nida Jawed; David F Choy; Joseph R Arron Journal: Mol Ther Date: 2008-02-05 Impact factor: 11.454
Authors: Min H Kang; Chandrakumar Balaratnasingam; Paula K Yu; William H Morgan; Ian L McAllister; Stephen J Cringle; Dao-Yi Yu Journal: Exp Eye Res Date: 2013-03-19 Impact factor: 3.467