Effectiveness and safety of ranibizumab 0.5 mg in treatment-naïve patients with diabetic macular edema: Results from the real-world global LUMINOUS study.

PURPOSE: To assess the one-year effectiveness and safety of ranibizumab 0.5 mg in treatment- naïve patients with diabetic macular edema (DME) enrolled in the real-world LUMINOUS study. PATIENTS AND METHODS: A 5-year, prospective, observational, open-label, global study which recruited 30,138 patients across all approved indications. Consenting patients (≥18 years) who were treatment-naïve or previously treated with ranibizumab or other ocular treatments were treated as per the local ranibizumab label. Here, we present the change in visual acuity (VA) (Early Treatment Diabetic Retinopathy Study letter score; primary treated eye) at Year 1, as well as the change in VA based on injection frequencies (≤4 and ≥5), treatment exposure, and the overall adverse events (AEs) and serious AEs (SAEs) in treatment-naïve DME patients. RESULTS: Of the 4,710 DME patients enrolled in the study, 1,063 were treatment-naïve. At baseline, mean age was 64.5 years, 54.7% were male, and 69.2% were white. At 1 year, mean VA letter score improved by +3.5 (n = 502) from a baseline of 57.7 with a mean of 4.5 injections. Presented by injection frequencies ≤4 and ≥5, VA letter score gains were 0.5 (n = 264) and 6.9 (n = 238) from baseline letter scores of 56.6 and 59.0, respectively. Over 5 years, the incidence of ocular/non-ocular AEs and SAEs was 7.2%/10.1% and 0.3%/5.8%, respectively. No endophthalmitis cases were reported. CONCLUSIONS: The LUMINOUS study included patients with DME with more diverse baseline characteristics than those in randomized clinical trials. The 1-year data showed improvement in VA with low number of injections in treatment- naïve patients with DME. Greater VA gains were observed in patients who received ≥5 injections. No new safety findings were identified. LUMINOUS confirms the effectiveness and safety of ranibizumab for the treatment of patients with DME in a real-world clinical practice.

Dellen formation as a complication of subconjunctival silicone oil following microincision vitrectomy.

PURPOSE: To study the subconjunctival silicone oil (SCSO) parameters associated with dellen formation following microincision vitrectomy (MIV). PATIENTS AND METHODS: This was a case-control study of 20 eyes with SCSO following MIV. Ten of them suffered postoperative dellen formation. Dellen occurrence, their sizes, number of loci, and distance between SCSO and the limbus were recorded. The outcome after silicone-oil removal was evaluated. RESULTS: The SCSO was at 3.1±1.2 mm from the limbus. All cases with dellen had SCSO within 2 mm of the limbus (P<0.001). No other factors were found to be associated with dellen formation (age, P=0.414; sex, P=0.656; laterality, P=1; indication for pars plana vitrectomy, P=0.655; instrument gauge, P=0.211; circumference involved by SCSO, P=0.252). All the dellen healed after surgical evacuation of SCSO (P<0.001), leaving scars. CONCLUSION: Dellen can be associated with MIV secondary to SCSO near the limbus. Resolution with scarring occurred following SCSO evacuation. Therefore, SCSO should be evacuated as early as possible to avoid long-term peripheral corneal morbidity.

The Effect of Laser Panretinal Photocoagulation on Diabetic Macular Edema Using the Pascal® Photocoagulator versus the Conventional Argon Laser Photocoagulator.

PURPOSE: The aim of this study was to compare the effect of panretinal photocoagulation for proliferative diabetic retinopathy (PDR) on diabetic macular edema (DME) using a Pascal® Photocoagulator (PP) or a conventional argon laser photocoagulator (CALP). METHODS: Eighty eyes with PDR and center-involving DME were randomized to PP or CALP. Both groups had baseline assessment of best-corrected visual acuity (BCVA) and were examined with optical coherence tomography and fluorescein angiography. RESULTS: The mean number of laser shots for the PP and CALP groups was 1,726.10 and 752.00 at session 1 and 1,589.00 and 830.00 (p < 0.001) at session 2, respectively. The mean central foveal thickness (CFT) at baseline was 306 ± 100 and 314 ± 98 for the PP and CALP groups, respectively. At 8 weeks, the mean CFT was 332 ± 116 and 347 ± 111 for the PP and CALP groups, respectively (p > 0.05). The mean BCVA was similar during the study period with no significant difference between the groups (p > 0.05). CONCLUSION: PP and CALP had similar effects on DME in PDR eyes and were equally safe with no significant increase in CFT.

Electrophysiological assessment of optic nerve and retinal functions following intravitreal injection of bevacizumab (avastin).

PURPOSE: To evaluate the retinal and optic nerve functions of bevacizumab when injected intravitreal in human eyes using electrophysiological tests; electroretinogram (ERG) and visual evoked potentials (VEP). METHODS: Fifty-five eyes of 55 patients with choroidal neovascular membrane (CNV) who were prepared for intravitreal injections of 1.25 mg bevacizumab underwent baseline ERG and VEP in both eyes before, and at 1 and 6 weeks after the intravitreal injections. RESULTS: Mean age was 50 years ranging from 24 to 62 years, with 32 age-related macular degenerations and 23 myopic patients. Mean baseline best corrected visual acuity (BCVA) was 4/60, and mean final BCVA at 6 weeks was 6/60. There was no statistically significant reduction of the postinjection (1 and 6 weeks) ERG A and B-waves or the VEP waves' amplitudes and latency, or in the contralateral noninjected eyes. On the contrary, there were statistically significant improvement at 1 and 6 weeks in the photopic B-wave of the injected and fellow eyes (P values=0.046, and <0.001). CONCLUSIONS: Intravitreal bevacizumab did not appear to be toxic to the retina or the optic nerve at a concentration of 1.25 mg.