Table 1 Examination schedule

Informed consent

X

Demographic data (age, gender)

X

Medical and ophthalmic history

X

Concomitant medications and procedures

X

X

X

X

X

X

X

X

Adverse events

X

X

X

X

X

X

X

X

NEI-VFQ-25/EQ-5D/ Compliance questionnaires

X

X

X

Vital signs (blood pressure/pulse)

X

X

X

Electrocardiogram

X

X

Haematology

X

X

X

Blood chemistry

X

X

X

Urinalysis

X

X

X

Obtain blood sample for risk factor substudy

X

Obtain blood sample for biomarker substudy

X

X

X

Pregnancy test (urine or serum)^a

X

Physical exam

X

Best-corrected visual acuity (BCVA) (ETDRS)

X

X

X

X

X

X

X

X

RAPD

X

Slit lamp biomicroscopy

X

X

X

X

X

X

X

X

Goldmann perimetry/semi-automatic kinetic perimetry

X^d

Schirmer test II (biomarker substudy)

X

X

X

Goldmann applanation tonometry (±1 h)

X^c

X

X

X

X

X

X

X^c

Gonioscopy (study eye only)

X

X

X

X

X

X

X

X

Anterior segment and gonioscopic photography^b

X

X

X

X

Posterior segment OCT (SD-OCT)

X

X

X

X

X

X

Indirect ophthalmoscopy

X

X

X

X

X

X

X

X

Fundus photography^b

X

X

X

Fluorescein angiography^b

X

X

X

Review inclusion/exclusion criteria

X

X

Randomisation

X

Administer study treatment (aganirsen or placebo)

X

Drug dispensing/return and bottle weight

X

X

X

X

X

X

Patient diary dispensing/return

X

X

X

X

X

X

Assess rescue treatment criteria

X

X

X

X

X

X