gms | German Medical Science

Purpose: Health care for nAMD patients is still a challenge for treating ophthalmological centers. This interim analysis of the non-interventional PACIFIC study will describe health-care parameters such as treatment regimens, diagnostic methods, health insurance status and treatment adherence of nAMD patients under real-life conditions.

Method: PACIFIC monitors anti-VEGF treatment with ranibizumab in treatment-naïve and pre-treated patients within an observational period for up to 24 months (m). Treatment, diagnosis and therapy monitoring are performed according to routine clinical practice and at the investigator’s discretion. 3492 patients provided entries at baseline (BL) and at a follow-up of at least 12 m, 60.48% of these are nAMD patients.

Results: Within the subgroup of 2112 German nAMD-patients, 59.8% are female with a mean age of 78.93 (+/-8.21 standard deviation). 84.1% of the patients are member of a social health insurance and 44.7% of patients’ therapy was covered within German intravitreal injection (IVI) contracts. The time observed from best corrected visual acuity (BCVA) examination of the study eye at BL to first treatment was 10.16 days +/-14.96 days (median 4 days). BCVA assessments occurred within 12 m and 24 m 5.92 times +/-3.22 (median 6) and 8.12 times +/-5.68 (median 7), respectively. In the same period of time optical coherence tomography (OCT) examinations were performed 3.24 times +/-2.74 (median 3) and 4.53 times +/-4.44 (median 3), respectively. The number of fluoresceine angiography (FA) assessments during 12 and 24 m were 0.57 +/-0.64 (median 1) and 0.63 +/-0.76 (median 1), respectively. A combination of OCT and FA assessment at baseline was performed for 35.09% of the patients, whereas neither OCT nor FA assessment at BL was performed for 13.16% of the patients. The planned therapy scheme of the study eye at BL was FIX = 41.6%, pro renata (PRN) = 35.7%, treat-and-extend (T+E) = 12.0% and monitor-and-extend (M+E) = 10.3% whereas the actually performed therapy scheme of the study eye confirmed to be FIX = 5.5%, PRN = 8.4%, T+E = 10.2% and M+E = 67.4%. With regard to 19338 documented follow up visits 45.8% were within a tolerated +20% time interval, 42.3% were within a tolerated -10% to +10% and 51.7% were within a tolerated -10 to +20% time interval.

Conclusion: PACIFIC provides real-life data on nAMD therapy with anti-VEGF ranibizumab and on routine health care structural use. The value of observational insights from routine clinical practice may lead to a better understanding of status quo and challenges in patient health care under real life settings.