A 2-Year, Phase IV, Multicentre, Observational Study of Ranibizumab 0.5 mg in Patients with Neovascular Age-Related Macular Degeneration in Routine Clinical Practice: The EPICOHORT Study
Table 2
Protocol deviations with respect to treatment compliance over 2 years.
Protocol deviation
Ranibizumab 0.5 mg total ()
At least one protocol deviation*, (%)
Injection of more than 0.5 mg (overdose)
1 (0.1)
Minor procedural deviations without obvious impact on the safety of the patient
379 (50.2)
No single use of vial (multiple injections)
40 (5.3)
Patient did not self-administer antimicrobial drops (4 times daily for 3 days) before or after the injection
360 (47.7)
Patient has no CNV secondary to AMD
2 (0.3)
Overall instances of each protocol deviation,
Injection of more than 0.5 mg (overdose)
1/1
Minor procedural deviations without obvious impact on the safety of the patient
575/379
No single use of vial (multiple injections)
40/40
Patient did not self-administer antimicrobial drops (4 times daily for 3 days) before or after the injection
2242/360
Patient has no CNV secondary to AMD
2/2
At least one section only counts a protocol deviation once per patient. Overall instance section reports all instances of each protocol deviation () and the total number of patients involved in those instances (). AMD: age-related macular degeneration; CNV: choroidal neovascularisation.
