Author: Alba Parrado-Carrillo
Co-authors: Ruben Martin-Pinardel, Aina Moll-Udina, Laura Sararols-Ramsay, Gonzaga Garay-Aramburu, Martin Puzo, Carolina Arruabarrena, Jose Garcia-Arumi, Maximino Abraldes, Jose Maria Ruiz-Moreno, Xavier Valldeperas, Daniel Velazquez-Villoria, Jose Juan Escobar-Barranco, Jacobo Gonzalez-Guijarro, Francisco Javier Ascaso-Puyuelo, Roberto Gallego-Pinazo, Marta S. Figueroa, Marc Figueras-Roca, Ricardo P. Casaroli-Marano, Javier Zarranz-Ventura
AbstractPurpose: To evaluate the clinical outcomes of anti-vascular endothelial growth factor (VEGF) drugs in naïve and previously treated neovascular AMD (nAMD) eyes nationwide, to investigate the adherence to clinical guidelines and benchmark the results with other international cohorts.
Setting/venue: Multicenter national nAMD database observational study of patients receiving anti-VEGF intravitreal injections (ranibizumab, aflibercept, bevacizumab) in 32 Hospitals.
Methods: Data collection was completed using an international consortium health outcome measurement (ICHOM)-compliant validated web-based tool (Fight Retinal Blindness! -FRB!- Project AMD module). All included nAMD eyes were treated with fixed bimonthly (FB) or treat-and-extend (TAE) regimens. The minimum data set included: demographics, visual acuity (VA) in logarithm of the minimum angle of resolution (logMAR) ETDRS letters at baseline and at all subsequent visits, number of injections and visits. Main outcome measures were baseline and final VA, VA change at 12 and 24 months, number of injections and visits.
Results: A total number of 4538 eyes of 3457 patients were included (treatment naïve n=3839, previously treated n=699). Mean (±standard deviation) baseline VA in the overall, treatment-naïve (TN) and previously treated (PT) cohorts was 57.8 (±19.9), 57.0 (±20.2) and 60.9 (±18.2) respectively (p<0.001). The final VA at 24 months was 58.7(±22.0), 58.8(±22.1) and 58.2(±21.3) (p=0.624). Mean VA change at 12/24 months was +3.2/+0.9 letters in the overall cohort, and +4.0/+1.7 letters in TN eyes and -0.1/-2.7 letters in PT eyes (p<0.001/p<0.001, respectively). The percentage of ≥15 letters losers/gainers at 24 months was 15.6%/19.5% overall, 15.3%%/21.7% in TN, and 16.9%/10.2% in PT eyes. The median number of injections/visits at 12 months was 7/8 overall, 7/8 in TN and 6/8 in PT (p<0.001/p=0.131) and at 24 months was 11/15 overall,11/15 in TN and 10/15 in PT (p=0.107/p=0.671), respectively. Study drugs included ranibizumab (37.7%), aflibercept (42.8%) and bevacizumab (19.5%).
Conclusions: This is the largest national, multicentric, real world study ever conducted in our country to audit the anti-VEGF therapy outcomes in nAMD nationwide using a web-based validated audit tool (FRB!). The results described here highlight significant differences between treatment naïve and previously treated eyes and represent an adequate measurement of the quality of care delivered nationwide, benchmarking the clinical management of nAMD at a country level compared to other real-world international cohorts. This study demonstrates that independent, large-scale national audits are feasible if committed health care professionals are provided with efficient information technology systems to do them.
Funding and financial disclosure: This work was supported in part by a grant from Novartis Pharmaceuticals. No member or affiliate of Novartis had any input into data analysis, interpretation of the data or writing the manuscript. Javier Zarranz-Ventura receive funding and consult for Novartis Pharmaceuticals and Bayer.