Pegcetacoplan Treatment and Consensus Features of Geographic Atrophy Over 24 Months.

Importance: Despite widespread availability and consensus on its advantages for detailed imaging of geographic atrophy (GA), spectral-domain optical coherence tomography (SD-OCT) might benefit from automated quantitative OCT analyses in GA diagnosis, monitoring, and reporting of its landmark clinical trials. Objective: To analyze the association between pegcetacoplan and consensus GA SD-OCT end points. Design, Setting, and Participants: This was a post hoc analysis of 11 614 SD-OCT volumes from 936 of the 1258 participants in 2 parallel phase 3 studies, the Study to Compare the Efficacy and Safety of Intravitreal APL-2 Therapy With Sham Injections in Patients With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (OAKS) and Study to Compare the Efficacy and Safety of Intravitreal APL-2 Therapy With Sham Injections in Patients With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (DERBY). OAKS and DERBY were 24-month, multicenter, randomized, double-masked, sham-controlled studies conducted from August 2018 to July 2020 among adults with GA with total area 2.5 to 17.5 mm2 on fundus autofluorescence imaging (if multifocal, at least 1 lesion ≥1.25 mm2). This analysis was conducted from September to December 2023. Interventions: Study participants received pegcetacoplan, 15 mg per 0.1-mL intravitreal injection, monthly or every other month, or sham injection monthly or every other month. Main Outcomes and Measures: The primary end point was the least squares mean change from baseline in area of retinal pigment epithelium and outer retinal atrophy in each of the 3 treatment arms (pegcetacoplan monthly, pegcetacoplan every other month, and pooled sham [sham monthly and sham every other month]) at 24 months. Feature-specific area analysis was conducted by Early Treatment Diabetic Retinopathy Study (ETDRS) regions of interest (ie, foveal, parafoveal, and perifoveal). Results: Among 936 participants, the mean (SD) age was 78.5 (7.22) years, and 570 participants (60.9%) were female. Pegcetacoplan, but not sham treatment, was associated with reduced growth rates of SD-OCT biomarkers for GA for up to 24 months. Reductions vs sham in least squares mean (SE) change from baseline of retinal pigment epithelium and outer retinal atrophy area were detectable at every time point from 3 through 24 months (least squares mean difference vs pooled sham at month 24, pegcetacoplan monthly: -0.86 mm2; 95% CI, -1.15 to -0.57; P < .001; pegcetacoplan every other month: -0.69 mm2; 95% CI, -0.98 to -0.39; P < .001). This association was more pronounced with more frequent dosing (pegcetacoplan monthly vs pegcetacoplan every other month at month 24: -0.17 mm2; 95% CI, -0.43 to 0.08; P = .17). Stronger associations were observed in the parafoveal and perifoveal regions for both pegcetacoplan monthly and pegcetacoplan every other month. Conclusions and Relevance: These findings offer additional insight into the potential effects of pegcetacoplan on the development of GA, including potential effects on the retinal pigment epithelium and photoreceptors. Trial Registration: ClinicalTrials.gov Identifiers: NCT03525600 and NCT03525613.

Slowing Down Myopia Progression with Contact Lenses - Everyday Cases from the Clinic.

BACKGROUND: An estimated 49.8% of the world population will be myopic by 2050. Multifocal contact lenses (MFCLs) and orthokeratology (OK) reduce peripheral retinal hyperopic defocus, which animal studies have shown to positively impact eye growth. MFCLs are expected to slow myopic progression by 20 - 50% and OK by 30 - 60%, making them valuable therapeutic tools. In view of the guidelines for myopia management published by the International Myopia Institute in 2019, the aim of this retrospective data analysis of a tertiary care center was to review past experience with OK and MFCLs for myopia control and gain information to update current practice. PATIENTS AND METHODS: The contact lens (CL) database of the Eye Clinic of the University Hospital of Basel was searched with the label "myopia progression" between January 2012 - 2020. Patients were included if they gave informed consent, were younger than 19 years old at baseline, and had no ocular comorbidities that could potentially compromise vision. Primary outcomes were progression of spherical equivalent refraction for MFCL patients and progression of axial length (AL) for the OK group, comparing with historical data from OK trials. Secondary outcomes were the presence of risk factors for myopia, age, refractive error at baseline, follow-up duration, and adverse effects during therapy. RESULTS: Twenty-one patients could be included, with a mean age of 12.80 ± 3.32 years (y) at baseline. The majority of patients were older than 12 years and already myopic (- 3.89 ± 2.30 diopters) when control treatment was started. Overall, follow-up ranged from 0.08 to 6.33 years (2.03 ± 1.66 y). In the patients treated with MFCLs, myopia control improved significantly when patients changed from spectacles to MFCLs. In the OK group, 14% dropped out during the first year and 2 patients had multiple AL measurements during therapy, which showed a slower growth of AL when compared to other OK trials and controls with spectacles. There were two cases of non-severe keratitis. Environmental risk factors had not been documented and only 48% of clinical records had a documented family risk assessment. CONCLUSION: Patients showed a slower myopia progression under MFCLs or OK, which supports their role as a treatment option in myopia management. In this regard, AL measurement is an important additional parameter to be included in the assessment of myopia progression in clinical practice. Identification of children at risk of developing high/pathologic myopia (family history, environmental risk factors) needs to improve so that the first stages of myopic shift can be recognized and targeted. Changes in lifestyle should be actively encouraged, especially when the impact of decreases in outdoor time secondary to COVID-19 is yet to become clear.