Table 20:
Real-World Clinical Management Studies of A-VEGF Treatment of n-AMD
| Author, Year, Country | Study Design and Follow-Up | Sites, Patients, Trial Arm | Follow-Up | Re-treatment Criteria |
|---|---|---|---|---|
| Bandukwala et al, 2010 (85) Ontario, Canada | Nonrandomized consecutive retrospective chart review 1 year | 1 academic site, 3 RPs; 94 Ps 3MoLD 0.5 mg ranibizumab and PRN re-treatment | Every 4–6 weeks or longer depending on physicians’ discretion and patient availability | 1) Persistent SRF 2) new macular hemorrhage 3) macular intraretinal edema or 4) worsening VA |
| Carneiro et al, 2012 (86) Portugal | Retrospective consecutively treated cohorts 1 year | 1 academic site, 186 Ps 1.25-mg 1MoLD of bevacizumab and PRN re-treatment (all treated before 2008) vs. 0.5-mg 3MoLD of ranibizumab and PRN re-treatment (all treated after 2008) | Follow-up at months 1, 2, 3, 4, 5, 6, 9, and 12 included ETDRS BCVA, funduscopic examination, and OCT | 1) Macular hemorrhage 2) presence of SRF or IRF on OCT or 3) leakage on FA. Reinjections were performed 5–7 days after medical visit |
| Cohen et al, 2009, (87) 2012 (93) France | Retrospective multicentre chart review 1 year | 3 academic sites, 6 RPs at Site 1, 1 RP at Sites 2 and 3; 290 Ps Site 1: 1MoLD (4 RPs) or 3MoLD (2 RPs) of ranibizumab and treat-and-extend maintenance Sites 2 and 3: 1MoLD of ranibizumab and PRN re-treatment | Site 1 (treat and extend), Sites 2 and 3 (PRN); visits included ETDRS BCVA, fundus ophthalmoscopy and photography, and OCT | Re-treatment protocol same across sites: 1) persistent subfoveal or perifoveal fluid 2) macular intraretinal edema 3) BCVA > 5 letters or 4) occurrence of new hemorrhage. In the absence of re-treatment criteria, exams were rescheduled 5–6 weeks later and then gradually spaced out |
| Dadgostar et al, 2009 (88) United States | Retrospective interventional case series 1 year | 1 private site, 124 Ps 0.5-mg 1MoLD of ranibizumab and PRN re-treatment | Serial clinical exams (interval not specified), Snellen BCVA, and OCT | 1) Increased retinal thickening 2) IRF, SRF, intraretinal cysts, or 3) increasing PED |
| Katz et al, 2012 (89) Ontario, Canada | Retrospective cohort study 1 year | 1 academic site, 2 RPs, 56 Ps RP 1: 0.5-mg 1MoLD of ranibizumab and monthly re-treatment RP 2: 0.5-mg 3MoLD of ranibizumab and treat-and-extend PRN re-treatment | Visits in treat-and-extend group were increased to a maximum of 2 months. Serial clinical exams included Snellen BCVA and every 4 months dilated funduscopy, repeat OCT, and FA | 1)Any SRF or IRF on OCT or 2) any subretinal hemorrhage on dilated funduscopy |
| Kumar et al, 2011 (90) United Kingdom | Prospective cohort study 1 year | 1 academic site, 81 Ps 0.5-mg 3MoLD of ranibizumab and PRN re-treatment | Serial clinical exams (interval not specified) included ETDRS BCVA, OCT | Deterioration in signs or symptoms included 1) decreased BCVA (5–19 letters) 2) worsening IRF or SRF or 3) fresh hemorrhage or extension of lesion on FA. Criteria were also included for cessation of treatment: 1)symptoms no better or worse 2) loss ≥ 30 letters over baseline 3), SRF absent or persistent but unresponsive to prior treatments 4), structural damage on OCT 5) fibrosis > 75% of the lesion involving the fovea or 6) serious adverse event |
| Michalova et al, 2009 (91) Australia | Retrospective chart review 1 year | 1 academic site, 4 RPs, 158 Ps 0.3 mg of ranibizumab (after April 2007 0.5 mg) and PRN re-treatment | No general protocol stated, serial clinical exams (interval not specified) included Snellen BCVA and OCT | Individual clinician judgment, re-treatment criteria not stated |
| Muether et al, 2013 (92) Germany | Prospective interventional case series 1 year | 1 academic site, 89 Ps 3MoLD of ranibizumab and PRN re-treatment 3 times with recurrent disease activity | Monthly visits included ETDRS BCVA, SD-OCT. FA performed only when CNV activity was questionable on SD-OCT images | PrONTO criteria; 1) recurrence of any SRF or cystic maculopathy on OCT in previously dry macula 2) CRT increased > 100 μm, 3) new area of classic CNV 4) new hemorrhage or 5) BCVA decreased 5 letters (from highest BCVA) and associated with leakage on FA or fluid on OCT |
Abbreviations: BCVA; best corrected visual acuity; CNV, choroidal neovascularization; CRT, central retinal thickness; FA, fluorescein angiography; IRF, intraretinal fluid; 1MoLD, 1-month loading dose; 3MoLD, 3-month loading dose; OCT, optical coherence tomography; P, patient; PED, pigment epithelium detachment; PRN, pro re nata (as needed); RP, retinal practices; SD-OCT; standard fluence optical coherence tomography; SRF, subretinal fluid; VA, visual acuity.