Outcomes measure
Diabetic Retinopathy, headache
DIABETIC RETINOPATHY
The primary outcome was ICP at 2.5 h, 24 h and 12 weeks post-drug administration. ICP was recorded with p-Tel telemetric ICP catheter and MPR-1 reader (Raumedic). ICP was recorded continuously for 30-min periods at specified time points in a standardized supine position. For the first 2.5 h post-dosing, mean ICP was calculated from each 30 min of continuous ICP monitoring. For the overnight recording the mean ICP was calculated from each hour of continuous ICP monitoring. ICP was sampled at 5 Hz. Recordings were downloaded and analysed in Dataview version 1.2 (Raumedic). ICP was recorded in mmHg (conversion factor to cmCSF was 1.36).Secondary outcomes included: monthly headache days, headache severity and monthly analgesia days, logMAR visual acuity measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) charts; PMD using Humphrey 24–2 SITA central threshold automated perimetry; BMI and health-related quality of life (measured by SF-36 and HIT-6). Evaluations were at baseline 2.5 h, 24 h and 12 weeks (with additional blood sampling at 2 weeks).