gms | German Medical Science

Introduction: The management of several macular disorders, including neovascular (wet) age-related macular degeneration (AMD), diabetic macular edema (DME), retinal vein occlusion (RVO) and myopic choroidal neovascularization (mCNV), has taken a major stride with the advent of Ranibizumab. We aim to formulate a consensus statement towards validating the contemporary evidence-based datasets for Ranibizumab

Methods: A series of nationwide, hybrid (10 virtual and 5 in person) meetings as collaborative educational initiative was convened in November 2022 to January 2023, by leading ophthalmologists (n=866) at the forefront of retina care (CARE Study Group). The cumulative clinical experience was approximately 21,000-man-years, who rated their level of agreement for 8 questions with each item on a 5-point Likert scale. This was preceded by a contemporary evidence-based discussion on the contemporary updates for Ranibizumab. Weighted mean for the Likert scale was calculated and consensus was pre-defined as a score > 100. GraphPad 9.5.1 and ANOVA were used for statistical analysis.

Results: The highest agreement score in the decreasing rank order (of the weighted mean score), for Ranibizumab was for; a transformative approach to enable access and affordability (120.6), an impactful published strength of evidence (119.8), an efficacious agent to manage RVO (119.7), variable factors that would determine the need for the number of injections of Ranibizumab to manage RVO (119.4), evidence for the utilisation of Ranibizumab is in alignment with the clinical experience in DME (118.2), adds transformative clinical value for the management of mCNV (115.8), in real World patients Ranibizumab when used for a long term has a trend towards gaining letters, with long term benefits as in LUMINOUS study (114), has the potential to revolutionize the treatment of proliferative diabetic retinopathy (112.2). The most preferred indication was DME (49.5%), followed by mCNV (30.8%), RVO (13.1%). The adjusted mean response scores (±SD, 95% CI) for consensus were for agree (81±13, 95% CI 70 to 92) followed by strongly agree (27±17, 95% CI 12 to 41), neither agree nor disagree (8.9±7.6, 95% CI 2.5 to 15), disagree (2.4±3, 95% CI -0.37 to 1.6)

Conclusions: We observed a high concordance for the usage of biosimilar Ranibizumab as it provides opportunity to decrease the cost, without compromising the safety and effectiveness. The high preference for usage in approved clinical indications is attributed to high level of real time clinical effectiveness. The outcome of the consensus reflects practical insights and guidance for use of Ranibizumab to enable remarkable impact on retina and vision care.