Table 17:

Study Characteristics of PRN A-VEGF Re-treatment Strategies for n-AMD in Long-Term Extension Trials

Study, Author, Year, Country	Study Design and Follow-Up	Sites, Patients, Trial Arms	Follow-Up Protocols	Re-treatment Protocol
SECURE, Silva et al, 2013 (81) Europe and Australia	Integrated follow-up of completers of 2 prior RCTs 3 years	SECURE: 41 sites, 10 countries, 234 Ps 0.5 mg of ranibizumab PRN, no more frequently than monthly (100/531 Ps from SUSTAIN RCT, 134/353 from EXCITE RCT) Followed by VA-guided PRN retreatment strategy	Monthly monitoring included ETDRS BCVA. OCT was not mandated by protocol and was performed at investigators’ discretion. Standard ophthalmic examinations were performed every 6 months including tonometry, indirect stereo ophthalmoscopy, and slit-lamp stereoscopic fundus biomicroscopy. Vital signs (systolic and diastolic blood pressure) and IOP was measured at 6-month visits and before any ranibizumab injections	Loss of > 5 ETDRS BCVA letters
HORIZON, Singer et al, 2012 (82) United States	Integrated follow-up of completers of 3 prior RCTs 4 years	HORIZON (853/1,301 Ps) (MARINA n = 716, ANCHOR n = 423, FOCUS n = 162)	Quarterly mandated visits (with discretional interval visits allowed) included physical examinations, eye exams, ETDRS BCVA, vital signs, and incidence of serum antibodies to ranibizumab. IOP was measured before injections	Re-treatment was at investigators’ discretion. There were no prescribed re-treatment criteria based on VA, OCT, FA, or other objective measure
Kruger et al, 2013 (79) Denmark	Retrospective single-centre study 4 years	1 site, 855 Ps 0.5-mg 3MoLD of ranibizumab and PRN re-treatment strategy	Follow-up visits conducted approximately monthly included ETDRS BCVA, funduscopy, and OCT. FA was reserved for unusual cases or treatment responses	Re-treatment followed national guidelines from Danish Ophthalmological Society. Treatment was terminated if no signs of disease activity 6 months after last injection or if BCVA had deteriorated after 3–6 injections
Muniraju et al, 2013 (80) United Kingdom	Retrospective single-centre study 3 years	1 site, 156 Ps 0.5-mg 3MoLD of ranibizumab and PRN re-treatment strategy	Follow-up schedule unreported, but visits included VA and OCT testing	Re-treatment based mainly on OCT-defined persistence, increased or new SRF and intraretinal edema, subretinal or intraretinal hemorrhage

Abbreviations: BCVA, best corrected visual acuity; FA, fluorescein angiography; IOP, intraocular pressure; 3MoLd, 3-month loading dose; OCT, optical coherence tomography; P, patient; PRN, pro re nata (as needed); RCT, randomized controlled trial; SRF, subretinal fluid; VA, visual acuity.