Rate Of Ocular Adverse Events Research Articles

Rates of Ocular Adverse Events after Intravitreal Faricimab Injections

Based on one-year experience with faricimab in a large retina-only practice, our study identified a 1.9% rate of serious ocular adverse events and a similarly low rate of intraocular inflammation that was comparable to clinical trials.

Management of macular oedema due to retinal vein occlusion: An evidence-based systematic review and meta-analysis.

Central retinal vein occlusion and branch retinal vein occlusion are common causes of visual loss due to associated macular oedema. The aim of this review was to assess the effectiveness of interventions improving vision and treating macular oedema in central retinal vein occlusion and branch retinal vein occlusion. Medical search engines and clinical trial registries were systematically searched. Randomised clinical trials with ≥90 eyes and real-world outcome studies with ≥100 eyes each with ≥6 months follow-up were included. There were 11 randomised controlled trials evaluating treatments for central retinal vein occlusion which met the inclusion criteria and 10 for branch retinal vein occlusion. There were 10 real world outcome studies of central retinal vein occlusion and 5 real world outcome studies of branch retinal vein occlusion. Meta-analysis was performed on studies that met the defined inclusion criteria. Main outcomes were change in visual acuity at 6-, 12-, 24- and 36 months by treatment. Intravitreal anti-vascular endothelial derived growth factor is recommended as first line treatment over intravitreal corticosteroid due to its effectiveness and lower rate of ocular adverse events. Best outcomes are achieved when intravitreal treatment is started early. Macular laser may have an adjunctive role in branch retina vein occlusion but not central retinal vein occlusion.

Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for neovascular age-related macular degeneration (TENAYA and LUCERNE): two randomised, double-masked, phase 3, non-inferiority trials

Faricimab is a bispecific antibody that acts through dual inhibition of both angiopoietin-2 and vascular endothelial growth factor A. We report primary results of two phase 3 trials evaluating intravitreal faricimab with extension up to every 16 weeks for neovascular age-related macular degeneration (nAMD). TENAYA and LUCERNE were randomised, double-masked, non-inferiority trials across 271 sites worldwide. Treatment-naive patients with nAMD aged 50 years or older were randomly assigned (1:1) to intravitreal faricimab 6·0 mg up to every 16 weeks, based on protocol-defined disease activity assessments at weeks 20 and 24, or aflibercept 2·0 mg every 8 weeks. Randomisation was performed through an interactive voice or web-based response system using a stratified permuted block randomisation method. Patients, investigators, those assessing outcomes, and the funder were masked to group assignments. The primary endpoint was mean change in best-corrected visual acuity (BCVA) from baseline averaged over weeks 40, 44, and 48 (prespecified non-inferiority margin of four letters), in the intention-to-treat population. Safety analyses included patients who received at least one dose of study treatment. These trials are registered with ClinicalTrials.gov (TENAYA NCT03823287 and LUCERNE NCT03823300). Across the two trials, 1329 patients were randomly assigned between Feb 19 and Nov 19, 2019 (TENAYA n=334 faricimab and n=337 aflibercept), and between March 11 and Nov 1, 2019 (LUCERNE n=331 faricimab and n=327 aflibercept). BCVA change from baseline with faricimab was non-inferior to aflibercept in both TENAYA (adjusted mean change 5·8 letters [95% CI 4·6 to 7·1] and 5·1 letters [3·9 to 6·4]; treatment difference 0·7 letters [-1·1 to 2·5]) and LUCERNE (6·6 letters [5·3 to 7·8] and 6·6 letters [5·3 to 7·8]; treatment difference 0·0 letters [-1·7 to 1·8]). Rates of ocular adverse events were comparable between faricimab and aflibercept (TENAYA n=121 [36·3%] vs n=128 [38·1%], and LUCERNE n=133 [40·2%] vs n=118 [36·2%]). Visual benefits with faricimab given at up to 16-week intervals demonstrates its potential to meaningfully extend the time between treatments with sustained efficacy, thereby reducing treatment burden in patients with nAMD. F Hoffmann-La Roche.

Clinical Outcomes After Bilateral Implantation of a Trifocal Presbyopia-Correcting Intraocular Lens in an Indian Population.

PurposeTo evaluate the effectiveness and safety of a presbyopia-correcting trifocal intraocular lens (IOL), AcrySof® IQ PanOptix® (TFNT00), in an Indian population.Patients and MethodsThis prospective, multicenter, observational, single-arm, post-marketing study included 67 patients undergoing cataract surgery with bilateral implantation of TFNT00 across five Indian sites. Postoperative outcomes were assessed at 3 months after second eye surgery. Effectiveness outcomes included: mean binocular and monocular visual acuity (VA) at distance (4 m), intermediate (60 cm), and near (40 cm); binocular defocus curve; manifest refraction; and subjective symptom questionnaire evaluation. Safety outcomes included the rate of ocular adverse events and mesopic contrast sensitivity.ResultsMean binocular and monocular distance-corrected and uncorrected VAs of 0.1 logMAR or better (approximately 20/25 Snellen) were achieved at distance, intermediate, and near. Overall, ≥70% of patients achieved binocular 0.1 logMAR vision or better across all distances. TFNT00 maintained a mean VA of 0.1 logMAR or better at the defocus range of +0.5 diopters (D) to –2.5 D (200 cm to 40 cm). The subjective symptom questionnaire-assessed frequency of halo visual disturbances was low at Month 3; halos were reported “none of the time” to “only some of the time” in 86.6% of patients. The large majority of patients (98.5%) were “satisfied” or “very satisfied” with their near, intermediate, and distance vision at Month 3, and ≥94.0% of patients reported spectacle independence for tasks at all distances. The adverse event rate was low; no patients discontinued due to an adverse event.ConclusionTFNT00 provided a continuous range of vision of 20/25 or better for distance to near and performed effectively at an intermediate functional distance of 60 cm, resulting in high levels of spectacle independence and patient satisfaction. TFNT00 demonstrated a good safety profile and a low post-operative frequency of halo visual disturbances.

Safety of soft contact lenses in children: retrospective review of six randomized controlled trials of myopia control.

To examine the rate and types of ocular adverse events among children wearing soft contact lenses. This study is a retrospective review of ocular adverse event data from six randomized controlled trials among a total of 581 myopic children (aged 7-15years at baseline) administered daily disposable hydrogel contact lenses (etafilcon A). During 816 patient years of contact lens wear, no significant or serious ocular adverse events were reported. A total of 86 non-significant ocular adverse events occurred in 53 children. The crude rate of ocular adverse events was 10.6 per 100 patient years with the estimated pooled incidence being 8.9 per 100 patient years (95% CI: 4.5-17.4). Two asymptomatic corneal infiltrative events were reported (both non-significant), which is an incidence of 0.3 (95% CI: 0.1-0.9) per 100 patient years. The most common ocular adverse events (n) were slit-lamp findings of Grade 2 or less requiring treatment (26), unspecified conjunctivitis (14), and allergic conjunctivitis (13). No cases of microbial keratitis were observed. Of the 86 adverse events, 37 were classified as highly likely or possibly lens-related, giving a crude incidence of 4.5 per 100 patient years for contact lens-related events. The crude incidence of ocular adverse events among spectacle wearers was 1.8 per 100 patient years. These data suggest that daily disposable soft contact lenses can be safely worn by children. Additional studies will be needed to precisely quantify the adverse event rate of soft contact lenses in normal clinical practice.

Comparative effectiveness and harms of intravitreal antivascular endothelial growth factor agents for three retinal conditions: a systematic review and meta-analysis.

Intravitreal antivascular endothelial growth factor (VEGF) agents are widely used to treat ocular conditions but the benefits and harms of these treatments are uncertain. We conducted a systematic review to compare the effects of aflibercept, bevacizumab and ranibizumab on best-corrected visual acuity (BCVA) changes, quality of life and ocular or systemic adverse events in patients with neovascular age-related macular degeneration (NVAMD), diabetic macular oedema (DME) and central or branch retinal vein occlusion (RVO). We searched published and unpublished literature sources to February 2017 for randomised controlled trials and cohort or modelling studies reporting comparative costs in the USA. Two reviewers extracted data and graded the strength of the evidence using established methods. Of 17 included trials, none reported a clinically important difference (≥ 5 letters) in visual acuity gains between agents. Nine trials provide high-strength evidence of no difference between bevacizumab and ranibizumab for NVAMD. Three trials provide moderate-strength evidence of no difference between bevacizumab and ranibizumab for DME. There was low-strength evidence of similar effects between aflibercept and ranibizumab for NVAMD, aflibercept and bevacizumab for RVO and all three agents for DME. There was insufficient evidence to compare bevacizumab and ranibizumab for RVO. Rates of ocular adverse events were low, and systemic harms were generally similar between groups, although 1 DME trial reported more arterial thrombotic events with ranibizumab versus aflibercept. Overall, no agent had a clear advantage over another for effectiveness or safety. Aflibercept and ranibizumab were significantly less cost-effective than repackaged bevacizumab in two trials. Systematic review registration number: CRD42016034076.

Combination of bevacizumab and photodynamic therapy vs. bevacizumab monotherapy for the treatment of wet age‑related macular degeneration: A meta‑analysis of randomized controlled trials

The purpose of this meta-analysis was to compare the efficacy and safety of the combination of bevacizumab and photodynamic therapy (PDT) with bevacizumab monotherapy for the treatment of age-related macular degeneration (AMD). Patients with active choroidal neovascularization (CNV) secondary to AMD were included in the present study. The treatment group included patients treated with a combination of bevacizumab and PDT and patients treated with bevacizumab monotherapy. Only randomized controlled trials (RCTs) were included in the analysis. The PubMed, EMBASE and Cochrane Central Register of Controlled Trials databases were searched. Meta-analysis was performed using RevMan v.5.3 software, and best-corrected visual acuity (BCVA), central retinal thickness (CRT) and the average number of bevacizumab retreatments were assessed. A total of 5 RCTs were included in the analysis. There were no significant differences observed in the mean BCVA change between the combination treatment group and the bevacizumab monotherapy group [standard mean difference 0.20; 95% confidence interval (CI) −0.53, 0.93, P=0.59]. There were also no significant differences in the CRT increases between the two groups [weighted mean difference (WMD) −22.16, 95% CI −52.01 to 7.69, P=0.15]. No significant differences were observed in the proportions of patients gaining >15 letters between the two groups [risk ratio (RR) 0.86, 95% CI 0.64, 1.15, P=0.30]. However, the average number of the ranibizumab retreatments was significantly lower in the combination treatment group compared with the bevacizumab monotherapy group (WMD, −2.70, 95% CI −3.93 to −1.46; P<0.0001). Additionally, there were no significant differences in the rate of ocular adverse events (RR, 0.57; 95% CI, 0.27 to 1.22; P=0.15) and systemic adverse events (RR, 5.42; 95% CI, 0.29 to 101.77; P=0.26) between the two groups. In conclusion there were no significant differences in mean BCVA change, CRT increases, the proportions of patients gaining >15 letters, or the incidences of ocular adverse events and systemic adverse events. However, combination treatment may significantly reduce the average number of bevacizumab retreatments compared with monotherapy.