AimsTo demonstrate non-inferiority of ranibizumab treat-and-extend (T&E) with/without laser to ranibizumab pro re nata (PRN) for best-corrected visual acuity (BCVA) in patients with diabetic macular oedema (DMO).MethodsA 24-month single-masked study with patients randomised 1:1:1 to T&E+laser (n=121), T&E (n=128) or PRN (control; n=123). All patients received monthly injections until BCVA stabilisation. The investigator decided on re-treatment in the PRN and treatment-interval adaptations in the T&E groups based on loss of BCVA stability due to DMO activity. Likewise, laser treatment was at investigator's discretion. Collectively, these features reflect a real-life scenario. Endpoints included mean average change in BCVA from baseline to months 1–12 (primary), mean BCVA change from baseline to months 12 and 24, treatment exposure and safety profile.ResultsBoth T&E regimens were non-inferior to PRN based on mean average BCVA change from baseline to months 1–12 (T&E+laser: +5.9 and T&E: +6.1 vs PRN: +6.2 letters; both p<0.0001). Mean BCVA change at month 24 was similar across groups (+8.3, +6.5 and +8.1 letters, respectively). The mean number of injections was 12.4 and 12.8 in the T&E+laser and T&E groups and 10.7 in the PRN group. The T&E regimens showed 46% reduction in the number of clinic visits. Over 70% of patients maintained their BCVA, with treatment intervals of ≥2 months over 24 months. Safety profile was consistent with that described in the product information.ConclusionsT&E is a feasible treatment option for patients with DMO, with a potential to reduce treatment burden. Slightly more injections were required versus PRN, likely due to the specifics of the T&E regimen applied here.Trial registration numberNCT01171976.

Patients with recent disease onset showed flecks with very short autofluorescence lifetimes, which is possible evidence of accumulation of retinoids deriving from the visual cycle. During the study period, many of these flecks changed to longer lifetimes, possibly due to accumulation of lipofuscin. Therefore, FLIO might serve as a useful tool for monitoring of disease progression. (ClinicalTrials.gov number, NCT01981148.).

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AimsTo determine the prevalence of polypoidal choroidal vasculopathy (PCV) in patients with presumed neovascular age-related macular degeneration (AMD) who were considered poor responders to ranibizumab.MethodsCaucasian patients with suspected neovascular AMD, presumed to be choroidal neovascularisation, previously treated with ≥8 intravitreal injections of ranibizumab 0.5 mg (Lucentis; Novartis AG, Basel, Switzerland) administered as required during optical coherence tomography-guided dosing were retrospectively included. Eyes were categorised according to the time from injection 1 to injection 6 (group 1: <12 months; group 2: ≥12 months). Indocyanine green angiography (ICGA) was used to re-evaluate eyes for PCV. Suitable candidates received reduced-fluence photodynamic therapy/ranibizumab combination therapy supplemented by ranibizumab monotherapy, as required.Results202 eyes were included (group 1: 73.8%; group 2: 26.2%). The prevalence of PCV in group 1 (21.5%) was significantly higher than in group 2 (3.8%; p=0.003). After initiation of combination therapy, 16 eyes with PCV received 3.1±2.5 ranibizumab injections/year vs 8.4±2.4 injections/year before initiation of combination therapy (p<0.001).ConclusionsIn Caucasian patients with presumed neovascular AMD, PCV prevalence is increased in eyes that respond poorly to ranibizumab monotherapy. ICGA improved PCV diagnosis in poor responders; combination therapy may be beneficial for eyes with PCV.

ABSTRACT.Purpose: To compare outcomes in patients with treatment-na€ ıve neovascular agerelated macular degeneration (nAMD) receiving ranibizumab treat and extend (TE) with those receiving ranibizumab pro re nata (PRN) in a clinical setting. Methods: During this 12-month retrospective, consecutive, comparative case series, patients received ranibizumab 0.5 mg according to a TE or PRN regimen. Monthly optical coherence tomography (OCT) evaluation was performed during the PRN regimen; retreatment criteria included recurrence of intra-/subretinal fluid, or haemorrhages. During the TE regimen, initial treatment with 4-week intervals was sequentially lengthened by 2 weeks until signs of choroidal neovascularization (CNV) activity recurred. Study end-points included mean change in best corrected visual acuity (BCVA) and central retinal thickness (CRT), mean injection frequency and number of follow-up visits attended. Results: Baseline characteristics were similar between the TE (n = 70) and PRN (n = 70) groups. Mean change in BCVA from baseline to Month 12 was significantly greater in the TE group than the PRN group (+0.18 AE 0.17 versus +0.07 AE 0.20, p < 0.001). Mean change in CRT from baseline to Month 12 was greater in the TE group than the PRN group (À116 AE 132 versus À58 AE 157 lm, p = 0.019). The number of follow-up visits attended was significantly higher in the PRN group than the TE group (11.9 AE 1.1 versus 8.6 AE 1.9, p < 0.001), while patients in the TE group received more injections during the study than those in the PRN group (8.6 AE 1.9 versus 6.0 AE 1.9, p < 0.001). Conclusion: Ranibizumab administered using a TE regimen in treatment-na€ ıve patients with nAMD provided better visual outcomes with fewer clinic visits, compared with a PRN regimen.

A TE regimen can improve and stabilise patient outcomes in nAMD compared with PRN, with the potential to reduce the healthcare resource burden incurred from fixed monitoring requirements.

Purpose: To investigate dexamethasone intravitreal implant 0.7 mg (DEX implant) for the treatment of diabetic macular oedema (DME) refractory to anti-vascular endothelial growth factor (anti-VEGF) therapy and evaluate predictive factors. Methods: Two-centre retrospective interventional case series, including 40 eyes of 31 patients treated with DEX implant for at least 2 consecutive cycles. Results: Mean ± SD intervals from implantation to recurrence in the first (4.2 ± 1.0 months) and second cycles (4.0 ± 0.9 months) were not significantly different. Best corrected visual acuity improved significantly (p < 0.001) by 7.0 ± 8.4 letters from baseline to month 2, and by 5.1 ± 6.9 letters between the first and second cycles. Central retinal thickness reduction 2 months after implantation was greater after the first (–194 ± 172 µm) than the second cycle (–134 ± 150 µm). Ellipsoid zone-external limiting membrane (EZ-ELM) disruption score decreased from 1.39 ± 1.16 at baseline to 1.24 ± 1.16 (p = 0.0832) after cycle 1 and remained stable 2 months after cycle 2. Eyes with persisting severe EZ-ELM disruption (score >2, n = 10) 2 months after the first DEX implant showed significantly (p = 0.0153) smaller visual acuity (VA) gains than eyes with less severe (score ≤2) EZ-ELM disruption. Conclusion: Repeated intravitreal DEX injections with average intervals of 4 months are valuable in patients with DME refractory to anti-VEGF therapy. Disorganization of outer retinal layers (EZ-ELM) may predict smaller VA gains if evaluated after initial reduction of macular oedema.

Isolated inferior oblique muscle weakening is an effective treatment option for superior oblique palsy up to 15 PD of vertical deviation in primary position. Two-muscle surgery should be reserved for patients with larger vertical deviations.