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Background and Objective: To report the 3-year outcomes for endolaserless vitrectomy with intravitreal aflibercept injection (IAI) monotherapy for proliferative diabetic retinopathy (PDR)-related vitreous hemorrhage (VH). Materials and Method: Eyes underwent endolaserless vitrectomy and received one preoperative and intraoperative IAI followed by randomization to a q8week or q16week IAI group. Additional IAI was administered as needed. Results: 31/40 eyes were randomized (14 q8week eyes, 17 q16week eyes). Through 152 weeks, q8week and q16week eyes received 18.6 and 12.1 IAI, respectively. Q8week eyes observed a 34 letter visual acuity (VA) increase ( P = 0.003) compared to a 27 letter increase in the q16week group ( P = 0.013). Conclusions: Endolaserless vitrectomy with aflibercept monotherapy for PDR-related VH provides significant long-term visual gains. Frequent IAI is required for fewer proliferative consequences. [ Ophthalmic Surg Lasers Imaging Retina 2023;54:89–96.]

In eyes with diabetic macular edema, the relative efficacy of administering aflibercept monotherapy as compared with bevacizumab first with a switch to aflibercept if the eye condition does not improve sufficiently (a form of step therapy) is unclear.At 54 clinical sites, we randomly assigned eyes in adults who had diabetic macular edema involving the macular center and a visual-acuity letter score of 24 to 69 (on a scale from 0 to 100, with higher scores indicating better visual acuity; Snellen equivalent, 20/320 to 20/50) to receive either 2.0 mg of intravitreous aflibercept or 1.25 mg of intravitreous bevacizumab. The drug was administered at randomization and thereafter according to the prespecified retreatment protocol. Beginning at 12 weeks, eyes in the bevacizumab-first group were switched to aflibercept therapy if protocol-specified criteria were met. The primary outcome was the mean change in visual acuity over the 2-year trial period. Retinal central subfield thickness and visual acuity at 2 years and safety were also assessed.A total of 312 eyes (in 270 adults) underwent randomization; 158 eyes were assigned to receive aflibercept monotherapy and 154 to receive bevacizumab first. Over the 2-year period, 70% of the eyes in the bevacizumab-first group were switched to aflibercept therapy. The mean improvement in visual acuity was 15.0 letters in the aflibercept-monotherapy group and 14.0 letters in the bevacizumab-first group (adjusted difference, 0.8 letters; 95% confidence interval, -0.9 to 2.5; P = 0.37). At 2 years, the mean changes in visual acuity and retinal central subfield thickness were similar in the two groups. Serious adverse events (in 52% of the patients in the aflibercept-monotherapy group and in 36% of those in the bevacizumab-first group) and hospitalizations for adverse events (in 48% and 32%, respectively) were more common in the aflibercept-monotherapy group.In this trial of treatment of moderate vision loss due to diabetic macular edema involving the center of the macula, we found no evidence of a significant difference in visual outcomes over a 2-year period between aflibercept monotherapy and treatment with bevacizumab first with a switch to aflibercept in the case of suboptimal response. (Funded by the National Institutes of Health; Protocol AC ClinicalTrials.gov number, NCT03321513.).

To determine if obstructive sleep apnea syndrome (OSAS) predisposes patients to glaucoma and macular disease due to vascular compromise by evaluating retinal and optic nerve vasculature and function using optical coherence tomography angiography and Humphrey visual field testing, respectively.In this prospective, observational, cross-sectional study 45 patients undergoing polysomnography ordered per standard of care were selected and stratified based on apnea-hypopnea index (AHI). Medical history, visual acuity testing, 24-2 Humphrey visual field, intraocular pressure measurement, and optical coherence tomography angiography studies of the macular and peripapillary retina were obtained. Correlations between polysomnography parameters and imaging data were analyzed.The radial peripapillary capillary vascular density demonstrated no relationship to AHI (95% confidence interval [CI] [-0.026,0.038]) or severity of OSAS (95% CI: [-0.772, 3.648]) for moderate OSAS compared to mild/normal and (-1.295, 3.1421) for severe compared to mild/normal. Optical coherence tomography angiography superficial parafoveal vascular density (95% CI: [-0.068,0.011], deep parafoveal vascular density (95% CI: [-0.080,0.009]), and foveal avascular zone (95% CI: [-0.001, 0.001]) showed no statistically significant relationship to AHI or OSAS severity after controlling for confounders. Optical coherence tomography retinal nerve fiber layer thickness increased with AHI (The severity of OSAS did not show a statistically significant effect on parameters associated with glaucoma or macular vascular disease. Larger cohorts may be required to determine the physiologic consequences of OSAS on the macular and optic nerve vasculature, structure, and function.Davanian A, Williamson L, Taylor C, et al. Optical coherence tomography angiography and Humphrey visual field in patients with obstructive sleep apnea.

PURPOSE: To describe the Port Delivery System with ranibizumab refill-exchange procedure. METHODS: Procedure based on the clinical trial program in patients with retinal diseases. RESULTS: The refill-exchange procedure is performed under topical anesthesia and strict aseptic conditions. Supplemental task lighting and magnification are recommended throughout the procedure. Ranibizumab is aseptically transferred from the vial with the filter needle and air is removed from the syringe. The filter needle is then replaced with the refill needle; any remaining air is removed from the syringe and the plunger is advanced to the 0.1-mL mark. Targeting the implant septum center, the refill needle is inserted perpendicularly to the globe until the soft stop contacts the conjunctiva (perpendicular orientation and conjunctival contact are maintained throughout the procedure); a cotton-tipped applicator is recommended for globe stabilization. The entire syringe contents are slowly injected over 5–10 seconds while existing solution fills the fluid collection reservoir. Once completed, the needle is carefully withdrawn while maintaining perpendicularity. The procedure can be successfully performed in rare, specific cases, including subconjunctival thickening or fibrous capsule formation, fluid-filled bleb formation, and corneal patch grafts. CONCLUSION: The procedure is straightforward but distinct from intravitreal injections and requires adherence to standardized techniques. With appropriate preparation, the procedure can be performed in specific cases. [ Ophthalmic Surg Lasers Imaging Retina. 2022;53:257–265.]

Purpose To determine if treatment with a photobiomodulation (PBM) device results in greater improvement in central subfield thickness as compared with placebo in eyes with center-involved diabetic macular edema (CI-DME) and good vision Design Phase 2 randomized clinical trial Participants Participants had CI-DME and visual acuity (VA) 20/25 or better in the study eye and were recruited from 23 clinical sites in the US. Methods One eye of each participant was randomly assigned 1:1 to a 670-nm light-emitting PBM eye patch or an identical device emitting broad-spectrum white light at low power. Treatment was applied for 90 seconds twice daily for 4 months. Main Outcome Measure Change in central subfield thickness (CST) on spectral-domain optical coherence tomography (OCT) at 4 months. Results From April 2019 to February 2020, 135 adults were randomly assigned to either PBM (N = 69) or placebo (N = 66); median age was 62, 37% were female and 82% were white. Median device compliance was 92% with PBM and 95% with placebo. OCT CST increased from baseline to 4 months by a mean (SD) of 13 (53) μm in PBM eyes and 15 (57) μm in placebo eyes (mean difference (95% CI) = -2 (-20 to 16) μm; p = .84). CI-DME, based on DRCR Retina Network sex and machine-based thresholds, was present in 61 (90%) of PBM eyes and 57 (86%) of placebo eyes at 4 months (adjusted odds ratio (95% CI) = 1.30 (0.44 to 3.83); p = .63). Visual acuity decreased by a mean (SD) of -0.2 (5.5) letters and -0.6 (4.6) letters in the PBM and placebo groups, respectively (difference (95% CI) = 0.4 (-1.3 to 2.0) letters; p = .64). There were eight adverse events possibly related to the PBM device, and two adverse events possibly related to the placebo device. None were serious. Conclusions PBM as given in this study, while safe and well tolerated, was not found to be effective for the treatment of CI-DME in eyes with good vision.