Table 2.
Summary of real-world studies evaluating the efficacy of ranibizumab in the management of neovascular age-related macular degeneration (nAMD).
| Study | Number of Patients/Country | Duration | Objective | Study Design | Treatment | Prior Treatments | Visual Acuity |
|---|---|---|---|---|---|---|---|
| Chavan et al. [56] | 123 eyes in 120 patients United Kingdom |
3 years | To describe bilateral visual outcomes after treatment, and the effects of incomplete follow up | Retrospective data collected over 36 months from consecutive patients over 9 months | 3 monthly injections of ranibizumab 0.5 mg followed by a pro re nata (PRN) dosing regimen | Naïve patients | Mean change in visual acuity (VA) from Baseline ETDRS letters −1.68 ± 17.76 |
| Cohen et al. [57] (LUMIERE) | 551 eyes in 551 patients France |
1 year | To survey compliance with recommended intravitreal ranibizumab treatment protocols in daily clinical practice in France, with reference to outcomes. | Retrospective, descriptive observational study. Data on patients were collected after 12 months of treatment with ranibizumab | 3 monthly injections of ranibizumab 0.5 mg followed by a PRN dosing regimen | Naïve patients | Mean change in VA from Baseline ETDRS letters +3.2 ± 14.8 |
| Finger et al. (WAVE) [58] | 3470 patients Germany |
1 year | Evaluation of efficacy and safety of repeated ranibizumab 0.5 mg injections | Prospective non interventional study including AMD patients from 274 practices over a defined period | 3 monthly injections of ranibizumab 0.5 mg followed by a PRN dosing regimen | Both naïve and previously treated were included | Mean change in BCVA +0.02 ± 0.01 SEM (LogMAR Snellen Values) |
| Frennesson and Nilson [59] | 312 eyes in 268 patients Sweden |
3 years | Evaluation of the effect of carrying forward the last VA of dropouts to the first evaluation point (to get more accurate results) | Retrospective data on patients treated with ranibizumab and followed up for 36 months | 3 monthly injections of ranibizumab 0.5 mg followed by a PRN dosing regimen | Both naïve and previously treated were included | Change in BCVA ETDRS: at 36 months +0.1 letter. However, if the last available acuity of dropouts was carried forward, VA decreased by 4.1 letters (p = 0.003) at 36 months |
| Gabai et al. [60] | 100 eyes in 92 patients Italy |
1 year | Evaluation of efficacy and safety profile of ranibizumab | Retrospective data was collected on patients with Ranibizumab treatment and follow-up for neovascular AMD for > 12 months | 3 monthly injections of ranibizumab 0.5 mg followed by a PRN dosing regimen | Naïve patients | Mean change in VA from Baseline ETDRS letters −2.0 ± 17.6 |
| Hjelmqvist et al. (Swedish Lucentis Quality Registry) [61] | 471 patients (272 retrospectively and 199 prospectively) Sweden |
1 year | Evaluation of efficacy of Ranibizumab | 12-month, open-label, observational, prospective, and retrospective study of ranibizumab administration for wet AMD | 3 monthly injections of ranibizumab 0.5 mg followed by a PRN dosing regimen | Not Mentioned | Mean change in VA from Baseline ETDRS letters +1.0 ± 13.6 |
| Holz et al. (AURA) [62] | 2227 patients, multicenter in Canada and Europe | 2 years | Evaluation of efficacy ranibizumab in management of wet AMD in a real-life setting | Retrospective non-interventional observational study | Treatment as prescribed by a physician (not all patients received 3 months loading dose) | Not mentioned. | Mean change in VA from Baseline ETDRS letters at 2 years +0.6 letters |
| Kumar et al. [63] | 81 eyes in 81 patients UK |
1 year | Evaluation of efficacy ranibizumab in management of wet AMD in a real-life setting | Prospective study following patients starting ranibizumab for wet AMD | 3 monthly injections of ranibizumab 0.5 mg followed by a PRN dosing regimen | Naïve patients | Mean change in VA from Baseline ETDRS letters +3.7 ± 10.8 |
| Matsumiya et al. [64] | 54 patients, 24 with wet AMD and 30 with PCV Japan |
1 year | Evaluation of the efficacy of ranibizumab in management of two types of AMD | Retrospective cohort study | 3 monthly injections of ranibizumab 0.5 mg followed by a PRN dosing regimen | Both naïve and previously treated were included | Change in BCVA at 12 months (log MAR values) PCV: −0.04 Typical AMD: −0.16 |
| Muether et al. [65] | 102 patients Germany |
1 year | Evaluation of the effect of latency and delay in initiation of treatment | Prospective study following patients with wet AMD | 3 monthly injections of ranibizumab 0.5 mg followed by a PRN dosing regimen. The German Health System caused a delay of 23.5 ± 10.4 days Between the decision to treat and initiation of treatment |
Naïve Patients | Mean change in VA from Baseline ETDRS letters +0.66 ± 16.82 |
| Nomura et al. [66] | 123 patients Japan |
1 year | Evaluation of the effect of Vitreomacular adhesions VMA during treatment with ranibizumab in patients with wet AMD | Retrospective study | 3 monthly injections of ranibizumab 0.5 mg followed by a PRN dosing regimen | Naïve patients | Mean change in VA from Baseline ETDRS letters Absent VMA: +6 letters VMA: +1.5 letters |
| Pagliarini et al. (EPICOHORT) [67] | 755 patients, 133 of which had bilateral treatment Europe |
2 years | Evaluation of the efficacy and safety profile of Ranibizumab in a real-life setting | Prospective, Phase 4 observational trial | 3 monthly injections of ranibizumab 0.5 mg followed by a PRN dosing regimen | Both naïve and previously treated were included | Mean change in VA from Baseline ETDRS letters At 12 months: +1.5 ± 0.61 (SEM) |
| Piermarocchi et al [68] | 94 eyes of 94 patients Italy |
1 year | Evaluation of the effect of genetic and non-genetic factors in treatment response to ranibizumab in wet AMD | Prospective study | 3 monthly injections of ranibizumab 0.5 mg followed by a PRN dosing regimen | Naïve Patients | Mean change in VA from Baseline ETDRS letters At 12 months 0.97 ± 9.1 |
| Rakic et al. (HELIOS) [69] | 309 eyes in 267 paients Belgium |
2 years | Prospective multicenter observational study | 3 monthly injections of ranibizumab 0.5 mg followed by a PRN dosing regimen | Both naïve and previously treated were included | Mean change in VA from Baseline ETDRS letters At 24 months −2.4 ± 17.4 |
|
| Zhu et al. [70] | 886 patients 208 eyes of 208 patients completed the study Australia |
5 years | Evaluation of the efficacy and safety profile of Ranibizumab in a real-life setting | Retrospective study | 3 monthly injections of ranibizumab 0.5 mg followed by a PRN dosing regimen | Both naïve and previously treated were included | Mean change in VA from Baseline ETDRS letters At 5 years: −2.4 |
ETDRS: Early Treatment Diabetic Retinopathy Study, BCVA: best corrected visual acuity, log MAR: logarithm of the minimum angle of resolution, PCV: polypoidal choroidal vasculopathy.