BMC Ophthalmol

BACKGROUND: This was an updated network meta-analysis (NMA) of anti-vascular endothelial growth factor (VEGF) agents and laser photocoagulation in patients with diabetic macular edema (DME). Unlike previous NMA that used meta-regression to account for potential confounding by systematic variation in treatment effect modifiers across studies, this update incorporated individual patient-level data (IPD) regression to provide more robust adjustment. METHODS: An updated review was conducted to identify randomised controlled trials for inclusion in a Bayesian NMA. The network included intravitreal aflibercept (IVT-AFL) 2 mg bimonthly (2q8) after 5 initial doses, ranibizumab 0.5 mg as-needed (PRN), ranibizumab 0.5 mg treat-and-extend (T&E), and laser photocoagulation. Outcomes included in the analysis were change in best-corrected visual acuity (BCVA), measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart, and patients with >/=10 and >/= 15 ETDRS letter gains/losses at 12 months. Analyses were performed using networks restricted to IPD-only and IPD and aggregate data with (i) no covariable adjustment, (ii) covariable adjustment for baseline BVCA assuming common interaction effects (against reference treatment), and (iii) covariable adjustments specific to each treatment comparison (restricted to IPD-only network). RESULTS: Thirteen trials were included in the analysis. IVT-AFL 2q8 was superior to laser in all analyses. IVT-AFL 2q8 showed strong evidence of superiority (95% credible interval [CrI] did not cross null) versus ranibizumab 0.5 mg PRN for mean change in BCVA (mean difference 5.20, 95% CrI 1.90-8.52 ETDRS letters), >/=15 ETDRS letter gain (odds ratio [OR] 2.30, 95% CrI 1.12-4.20), and >/=10 ETDRS letter loss (OR 0.25, 95% CrI 0.05-0.74) (IPD and aggregate random-effects model with baseline BCVA adjustment). IVT-AFL 2q8 was not superior to ranibizumab 0.5 mg T&E for mean change in BCVA (mean difference 5.15, 95% CrI -0.26-10.61 ETDRS letters) (IPD and aggregate random-effects model). CONCLUSIONS: This NMA, which incorporated IPD to improve analytic robustness, showed evidence of superiority of IVT-AFL 2q8 to laser and ranibizumab 0.5 mg PRN. These results were irrespective of adjustment for baseline BCVA

Multicenter evaluation of tendency-oriented perimetry (TOP) using the G1 grid

PURPOSE: The G1-TOP program is a short automated perimetric strategy which sub-divides the G1 grid of 59 points into four sub-grids. Each point is tested only once, but each patient's response is used to modify that particular point and the surrounding ones from the remaining sub-grids. This study compared the results of the G1-TOP program with the Standard Bracketing strategy. METHODS: Eleven participating institutions provided data from 213 patients (406 eyes). The main group consisted of 284 glaucomas and 55 glaucoma suspects. Other groups included 31 eyes with neurological disorders, 20 with chorioretinal lesions and 16 normal eyes. Mean age was 62.7 +/- 15.4 (range 14-88) years. All subjects had previous perimetric experience and visual acuity better than 0.5. Examination included G1-Standard Bracketing and G1-TOP testing, in interchangeable order, with the Octopus 1-2-3 perimeter. RESULTS: The correlation coefficient for mean defect (MD) was 0.95. Standard error (YX) for MD, square root of loss variance (LV) and individual thresholds were 1.86 dB, 1.29 dB, and 4.72 dB, respectively. Mean sensitivity values were similar (difference 0.04 +/- 1.87 dB) (p>0.05). Mean duration for G1-TOP was 2.19 +/- 0.26 min, while G1-Standard Bracketing took 11.51 +/- 1.52 min (ratio 1/5.1, or a net reduction of 80.4%). The sensitivity of G1-TOP versus G1-Standard Bracketing was: glaucoma 77.1/78.5, glaucoma suspects 38.2/47.3, neurological disorders 87.1/87.1 and chorioretinal lesions 80.0/85.0. CONCLUSIONS: The G1-TOP program gave very similar results to G1-Standard Bracketing in only 20% of the time required by the standard strategy

Ranibizumab 0.5 mg treat-and-extend regimen for diabetic macular oedema: The RETAIN study

Aims To 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).Methods A 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.Results Both 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= 2 months over 24 months. Safety profile was consistent with that described in the product information.Conclusions T&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