Table 1.
Assessment | Screening | SRT with baseline ranibizumaba | Monthly reviewb (months 1–11) | Month 12 | Monthly reviewb (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 angiographyc (sent to reading centre) | X | |||||||
Stereotactic radiotherapy with mandated baseline ranibizumaba | 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 questionnairesd | 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