Author: Nitin Maksane (India)
Co-authors: Maulik Bhavsar
Purpose
Age-related macular degeneration (AMD) is responsible for 8.7% of global blindness with its impact severe in the developing countries, such as India. The neovascular AMD (nAMD), sub-type accounts for 90% of severe vision impairment cases. The anti-vascular endothelial growth factor (anti-VEGF) agents are mainstay of treatment and have been able to preserve the vision and improve the quality of life (QoL) in nAMD. Despite, clinical trials demonstrating positive visual outcomes with agents over different study durations, the real-world evidences have reported attenuated visual gains. It has been observed that on prolonged use, there is a difference in response to the anti-VEGF therapy at patient level, apart from difference in tolerance level. Moreover, there exists very limited real-world clinical data/ with studies restricted to a few clinics/ institutes or a specific region within the Indian subcontinent. Thus, the objective of this study is to understand real-world data for visual acuity (VA) related outcomes, treatment patterns including injection burden, treatment adherence and monitoring patterns in the real world setting amongst nAMD patients in India. This study aims to gain insights on the overall treatment compliance with follow-up data of at least 2 years.
Setting/Venue
This is a non-interventional, retrospective, non-comparative, non-randomized study across multiple zones (multi-centre) in India. The study will include treatment naïve nAMD, newly diagnosed patients ≥50 years of age (at Index date). Secondary data source i.e., Electronic Medical Record (EMR) database of Retina Clinics/ Hospitals from different zones across India will be used to collect approximately 300 anonymized patients’ data for over a period of at least 24 months of follow-up period to analyze primary, secondary and exploratory objectives.
Methods
The study will aim to enroll approximately 300 patients from approximately 8-10 sites across north, south, east and west zones of India during the study period (01 Mar 2015 and 30 Mar 2020). The study will include newly diagnosed treatment naïve nAMD patients aged ≥ 50 years of age at Index date; who received ranibizumab or aflibercept or bevacizumab or biosimilar ranibizumab between 01 Mar 2015 and 30 Mar 2018 (Index period). The eye will be the unit of analysis in this study; therefore, a patient may have one or two study eyes. Other additional inclusion criteria for this study includes patients with VA/OCT assessments at baseline, Month 12 and Month 24; patients treated with intravitreal injection of anti-VEGF (received at least one anti-VEGF injection during the post-index follow-up period and at least 2 visits with OCT in between Months 0-12); and patients with minimum follow-up period of 24 months. (Received at least one anti-VEGF injection and at least 1 visit with OCT in between Months 13-24) All data extracted from EMR shall be anonymized. The study has been registered on CTRI (Clinical Trials Registry of India) and has been initiated after approval from local ethics committee of selected sites.
Results
Demographic profile and baseline characteristics of nAMD patients would be recorded (age, gender, co-morbidities, findings of fundus fluorescein angiography [FFA], color fundus photography [CFP], OCT, etc.). The data collected will be used to evaluate the effect of anti- VEGF agents on anatomical parameters (CRT, fluid) at months 3, 6, 18 & 24 and study its association with changes in functional outcome from baseline to Months 3, 6, 18 and 24. Also the data would be used to characterize the treatment patterns with anti-VEGF therapy, total number of visits, number of anti-VEGF injections and number of non-injection visits during the first 2 years of treatment after initiation of an anti-VEGF agent (Month 0-12, Month 13-24). Furthermore, the data collected will also be utilized to characterize the number of fluid free visits, treatment compliance and anti-VEGF switch rate. The primary objective is to explore the association between anatomical outcomes (presence/absence) at Month 12 and changes in functional outcome at Month 12. 5. The predictive value of age, baseline VA, proper loading phase (yes/no), number of anti-VEGF injections (maintenance phase), baseline IRF (Intra-retinal fluid) (presence/absence), baseline SRF (Sub-retinal fluid) (presence/absence) on the VA gains at Month 12 would be also studied.
Conlusions
This first of its kind pan- India multi-centre real world study using EMR data analysis will help to understand the patient characteristics and demographics, current treatment patterns with anti-VEGF injections and VA outcomes, association of visual and anatomical outcomes, treatment burden and adherence. The data generated through this study will assist in adapting the real world Anti-VEGF treatment patterns and outcomes to take a rationale evidence based decision in clinical practice to better manage nAMD patients in Indian subcontinent
Financial Disclosure
Novartis India limited as we are are employees of the company
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