StereoTactic radiotherapy for wet Age-Related macular degeneration (STAR): study protocol for a randomised controlled clinical trial

Table 1 Schedule of enrolment, interventions and assessments

Assessment	Screening	SRT with baseline ranibizumab^a	Monthly review^b (months 1–11)	Month 12	Monthly review^b (months 13–23)	Month 24	Month 36	Month 48
Visit window: Day 0 = day of successful enrolment	Day -14 to 0	Day 0 to 21	±7 days	±7 days	±7 days	±7 days	±14 days	±14 days
Informed consent	X
Demographics	X
Ophthalmic history	X
Med. history/con meds	X
Blood pressure	X
ETDRS visual acuity	X		X	X	X	X	X	X
Intraocular pressure	X			X		X	X	X
Cataract assessment	X			X		X	X	X
Biometry	X
OCT (sent to reading centre)	X			X		X	X	X
OCT (not sent to reading centre)	X		X		X
Fundus photographs (sent to reading centre)	X			X		X	X	X
Fluorescein angiography (sent to reading centre)	X			X		X	X	X
Indocyanine green angiography^c (sent to reading centre)	X
Stereotactic radiotherapy with mandated baseline ranibizumab^a		X
Ranibizumab injection if required (prn)			X	X	X	X	X	X
Health Economics questionnaires			X	X	X	X	X	X
EQ-5D and VFQ-25 patient questionnaires^d	X			X		X	X	X
Adverse events/ConMed changes			X	X	X	X	X	X

^aThe baseline mandated ranibizumab injection should be given at the national treatment centres following stereotactic radiotherapy
^bMonthly review entails review every 28 days rather than by calendar month. The first monthly review should be scheduled 28 ± 7 days after stereotactic radiotherapy/baseline ranibizumab. It is preferable to allow at least 23 days between visits, as this is the minimum time between ranibizumab injections
^cIndocyanine green may be omitted in centres that do not have indocyanine green capability, if pre-agreed by Sponsor
^dA treatment satisfaction questionnaire will also be administered by the Sponsor, via telephone. The satisfaction questionnaire is undertaken by central staff, as participants may feel more at liberty to discuss their level of satisfaction without concern that it will affect their local care

ISSN: 1745-6215