Comparison of Physician and Nurse-Administered Intravitreal Injections of anti-vascular endothelial growth factor, a Randomized Noninferiority Trial.

Abstract

Purpose : Intravitreal injections (IVI) of anti-vascular endothelial growth factor (anti-VEGF) represent a considerable workload on ophthalmologic clinics. Nurse-administered IVI may relieve this workload, but the safety of such an extended role for nurses in ophthalmologic clinics has not earlier been investigated. To this end we performed a noninferiority single-blinded randomized controlled trial comparing independent anti-VEGF IVI by trained nurses and physicians with safety measured as change in visual acuity during a 12 month observation period as the main outcome.

Methods : 342 patients with either age-related macular degeneration, retinal vein occlusion or diabetic macular edema that were eligible for anti-VEGF IVI and able to give an informed consent were randomized to IVI administration during 12 months by either trained nurses or physicians. Both newly diagnosed patients and patients that were already receiving anti-VEGF IVI fulfilled the inclusion criteria. All patients were recruited from a tertiary level ophthalmological clinic in Norway. Patients were blinded to treatment group. The primary outcome was safety, measured by difference between the two groups in mean change in visual acuity during an observation period of 12 months. We used the Early Treatment Diabetic Retinopathy Study chart at a starting test distance of 2 meter. All serious adverse events were registered. 130 patients in the nurse group and 129 in the physician group were eligible for the analysis, when including patients for which at least 80% of the injections were performed according to the randomization group.

Independent samples t-test with a noninferiority margin of 3 letters and a confidence interval (CI) of 95% was used when analyzing the difference in mean change in visual acuity.

Results : Mean letters gained during the observation period was 0.7 and 1.6 in the trained nurse and physician group, respectively. The mean difference between groups was -0.9 letters (95% CI: -2.9, +1.0). The corresponding estimate for intention to treat analysis (ITT) was -2.2 letters (95% CI: -4.4, +0.0). Three serious adverse events were registered in the observation period, all in the nurse group.

Conclusions : The safety of nurse-administered anti-VEGF injections during 12 months was noninferior to that of physician-administered injections.

This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.