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.

ISTRN 90646644.

Background: We evaluated, in a nonrandomised, institutional, prospective study, the efficacy of photodynamic therapy (PDT) with verteporfin in age-related macular degeneration (AMD) eyes with polypoidal choroidal vasculopathy (PCV) and subfoveal exudation. Methods: A prospective clinical and angiographic study was done in 40 consecutive eyes with PCV treated with PDT using masked best-corrected visual acuity (VA) and fluorescein and indocyanine green angiographic features at baseline and over 2 years. Results: Twenty-one eyes completed 1-year follow-up and showed, after a mean 2.9 PDT sessions, VA improvement in 12 eyes, no change in five eyes, and VA decrease in four eyes. Leakage was absent at the retinal and choroidal level in 14 eyes at 1 year. Recurrence occurred in one eye during the first year. Six eyes completed 2 years of follow-up and showed, after a mean 4 PDT sessions, VA improvement in five eyes and VA decrease in one eye. Leakage was absent at the retinal and choroidal level in five eyes. Recurrence occurred in four of these six eyes during the second year of follow-up. No serious adverse events were observed during the 2 years of follow-up. Conclusions: PDT with verteporfin was shown to be safe and effective for treating AMD eyes with PCV with subfoveal involvement. VA improvement and absence of leakage were achieved, respectively, in 57.1% and 66.6% of the eyes at 1 year. Recurrences were more frequent during the second year of follow-up.

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Swept-source optical coherence tomography demonstrates a significant reduction of CT in PDR compared with controls. In the foveal region, the choroid appears to be thinner in DR eyes than in diabetic eyes without retinopathy.

Choroidal vascular density and volume are significantly reduced in more advanced stages of diabetic retinopathy. New imaging modalities should allow further exploration of the contributions of choroidal vessel disease to diabetic eye disease pathogenesis, prognosis, and treatment response.

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