To assess the noninferiority of the treat-and-extend (T&E) and fixed bimonthly regimens of 0.5 mg intravitreal ranibizumab as compared with the pro re nata (PRN) in na€ ıve patients with neovascular age-related macular degeneration (nAMD). Methods: Phase IV, randomized, 12-month, multicentre trial. Patients aged ≥50 years with nAMD and visual impairment [best-corrected visual acuity (BCVA) between 23 and 78 Early Treatment Diabetic Retinopathy Study (ETDRS) letters] were eligible. Patients (one eye per patient) were randomized to bimonthly, n = 103, T&E, n = 99 or PRN, n = 104. Noninferiority was established at five letters ETDRS. Results: The mean (95% CI) difference in BCVA at 12 months was 7.2 (4.2-10.2), 6.4 (2.9-9.8), and 8.0 (51.1-11.0) in the bimonthly, T&E and PRN, respectively. The bimonthly or T&E regimens were not inferior to the PRN scheme. All regimens were associated with a significant reduction of central subfield thickness and volume. The mean (95% CI) number of injections in the bimonthly regimen (7.6, 7.5-7.7) was similar as compared with the PRN regimen (7.4, 6.7-8.0) (p = 0.159) but lower than in the T&E regimen (9.3, 8.9-9.7) (p < 0.001). Conclusion: At 12 months, bimonthly and T&E ranibizumab were noninferior to PRN in na€ ıve nAMD. Key words: best-corrected visual acuity-fixed bimonthly-intravitreal anti-VEGF-neovascular age-related macular degeneration-pro re nata-ranibizumab-treat-and-extend † The In-Eye Study Group members are listed in Appendix 1.

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Background: To study the visual outcomes of neovascular AMD (nAMD) treated with anti-vascular endothelial growth factor (VEGF) drugs at national level.Methods: Multicenter national database of nAMD eyes treated with anti-VEGF intravitreal injections (ranibizumab, aflibercept, bevacizumab) in fixed bimonthly (FB) or treat-and-extend (TAE) regimens. Demographics, visual acuity (VA) in logarithm of the minimum angle of resolution (logMAR) ETDRS letters at baseline and subsequent visits, number of injections and visits data were collected using a validated web-based tool (Fight Retinal Blindness!). Results: 1273 eyes (1014 patients) were included, 971 treatment naïve (TN) and 302 previously treated (PT). Baseline VA (mean ± SD) was 57.5 (±19.5) and 62.2 (±17) (p > 0.001), and 24 months final VA was 60.4 (±21.2) and 58.8 (±21.1) (p = 0.326), respectively. Mean VA change at 12/24 months was +4.2/+2.9 letters in TN eyes and +0.1/À3.4 letters in PT eyes (p < 0.001/p < 0.001). The percentage of ≥15 letters gainers/losers at 24 months was 24.8%/14.5% in TN, and 10.3%/15.7% in PT eyes. The median number of injections/visits at 12 months was 7/9 in TN and 6/8 in PT (p = 0.002/p < 0.001) and at 24 months was 11/16 in TN and 11/14 in PT (p = 0.329/p < 0.001). Study drugs included ranibizumab (39.5%), aflibercept (41.2%) and bevacizumab (19.3%).

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Purpose: To describe the utility of high dynamic range optical coherence tomography imaging to study subretinal hyperreflective material (SHRM) in patients with age-related macular degeneration.Methods: Clinical information including visual acuity and optical coherence tomography images (Heidelberg Engineering GmbH, Heidelberg, Germany) of patients undergoing antiangiogenic treatment for neovascular age-related macular degeneration and showing SHRM at baseline were retrospectively reviewed. Contrast between strong signal structures (high dynamic range image) reclassifying SHRM as hyperreflective (HyperR), isoreflective, and hyporeflective was increased. The patients at baseline, 3, 6, and 12-months follow-up were evaluated.Results: Forty-four eyes were classified as 15 HyperR (34.1%), 21 as isoreflective (47.7%), and eight as hyporeflective (18.2%). During follow-up, hyporeflective SHRM disappeared in all cases, isoreflective SHRM faded in 16 cases (76.2%); HyperR SHRM remained in all cases. Hyporreflective SHRM showed a greater visual acuity improvement than HyperR SHRM group (P = 0.033). After 12-month follow-up, only the hyporeflective and isoreflective groups significantly reduced the presence of fluid in 37.5% (P = 0.250) and 46.62% (P = 0.006) of the patients, respectively; outer retinal layers were disrupted more frequently in the presence of HyperR SHRM (ellipsoid zone, P = 0.16; external limiting membrane, P = 0.007).Conclusion: Contrast-enhanced optical coherence tomography images enabled us to classify SHRM according to its reflectivity, showing groups with different disappearance rates, visual acuity improvement, and outer retinal layer disruption. This easy-to-access tool may be helpful as a prognostic factor in neovascular age-related macular degeneration cases.