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To reduce treatment burden and optimise patient outcomes in diabetic macular oedema, we present 1-year results from two phase 3 trials of faricimab, a novel angiopoietin-2 and vascular endothelial growth factor-A bispecific antibody.YOSEMITE and RHINE were randomised, double-masked, non-inferiority trials across 353 sites worldwide. Adults with vision loss due to centre-involving diabetic macular oedema were randomly assigned (1:1:1) to intravitreal faricimab 6·0 mg every 8 weeks, faricimab 6·0 mg per personalised treatment interval (PTI), or aflibercept 2·0 mg every 8 weeks up to week 100. PTI dosing intervals were extended, maintained, or reduced (every 4 weeks up to every 16 weeks) based on disease activity at active dosing visits. The primary endpoint was mean change in best-corrected visual acuity at 1 year, averaged over weeks 48, 52, and 56. Efficacy analyses included the intention-to-treat population (non-inferiority margin 4 Early Treatment Diabetic Retinopathy Study [ETDRS] letters); safety analyses included patients with at least one dose of study treatment. These trials are registered with ClinicalTrials.gov (YOSEMITE NCT03622580 and RHINE NCT03622593).3247 patients were screened for eligibility in YOSEMITE (n=1532) and RHINE (n=1715). After exclusions, 940 patients were enrolled into YOSEMITE between Sept 5, 2018, and Sept 19, 2019, and 951 patients were enrolled into RHINE between Oct 9, 2018, and Sept 20, 2019. These 1891 patients were randomly assigned to faricimab every 8 weeks (YOSEMITE n=315, RHINE n=317), faricimab PTI (n=313, n=319), or aflibercept every 8 weeks (n=312, n=315). Non-inferiority for the primary endpoint was achieved with faricimab every 8 weeks (adjusted mean vs aflibercept every 8 weeks in YOSEMITE 10·7 ETDRS letters [97·52% CI 9·4 to 12·0] vs 10·9 ETDRS letters [9·6 to 12·2], difference -0·2 ETDRS letters [-2·0 to 1·6]; RHINE 11·8 ETDRS letters [10·6 to 13·0] vs 10·3 ETDRS letters [9·1 to 11·4] letters, difference 1·5 ETDRS letters [-0·1 to 3·2]) and faricimab PTI (YOSEMITE 11·6 ETDRS letters [10·3 to 12·9], difference 0·7 ETDRS letters [-1·1 to 2·5]; RHINE 10·8 ETDRS letters [9·6 to 11·9], difference 0·5 ETDRS letters [-1·1 to 2·1]). Incidence of ocular adverse events was comparable between faricimab every 8 weeks (YOSEMITE n=98 [31%], RHINE n=137 [43%]), faricimab PTI (n=106 [34%], n=119 [37%]), and aflibercept every 8 weeks (n=102 [33%], n=113 [36%]).Robust vision gains and anatomical improvements with faricimab were achieved with adjustable dosing up to every 16 weeks, demonstrating the potential for faricimab to extend the durability of treatment for patients with diabetic macular oedema.F Hoffmann-La Roche.

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.

A 62-year-old human immunodeficiency virus (HIV)–positive Caucasian man presented with 3 days of painless vision loss in the left eye. The right eye demonstrated optic disc edema and the left a deep, orange-yellow placoid lesion in the posterior pole. A broad differential diagnosis was entertained, including syphilis, viral retinitis, tuberculosis, primary toxoplasmosis, and endogenous infectious chorioretinitis. Syphilis serology was positive, and the patient responded to intravenous penicillin combined with prednisone.

A 38-year-old black Haitian male presented with worsening vision and floaters in his right eye for the past 2 weeks. The day before symptoms started, the patient felt a foreign body sensation while cutting lumber. He was evaluated by an outside physician, who started the patient on difluprednate drops without improvement. Later examination revealed panuveitis with extensive retinitis. Polymerase chain reaction testing of the aqueous humor was positive for varicella zoster virus. The patient responded to high-dose antivirals. His course was complicated by retinal detachment, which was successfully repaired with a combined scleral buckle and pars plana vitrectomy procedure.

To present pre-papillary vitreous opacity as an uncommon manifestation of inflammation in Behcet’s disease that may be specific to this uveitic entity. We retrospectively reviewed the charts of 67 patients with Behcet’s disease examined at our clinic between 2005 and 2016. Behcet’s disease was diagnosed based on established clinical criteria of inflammation involving the eyes, mucocutaneous junctions, and skin. Patients with Behcet’s disease who presented with papillitis and a pre-papillary vitreous opacity were identified. Response to anti-inflammatory treatment on examination and optical coherence tomography imaging were evaluated. PubMed searches were performed for (1) other cases with pre-papillary vitreous opacities in uveitic entities and (2) reports of optic nerve involvement specifically in Behcet’s disease. We identified three patients with Behcet’s disease who presented with unilateral papillitis and a pre-papillary vitreous opacity. The pre-papillary vitreous opacity had a funnel-shaped appearance on optical coherence tomography. All patients were initially treated with steroids, which led to resolution of the opacity clinically and on imaging. We identified one previous report of such a pre-papillary opacity in a patient with Behcet’s disease, and no reports of this finding in other uveitic entities. This study expands the number of Behcet’s disease cases presenting with a pre-papillary vitreous opacity and demonstrates novel optical coherence imaging of this finding. This finding may be specific to Behcet’s disease as it was not identified in other uveitic entities in a review of the existing literature.

PurposeTo assess the extended efficacy and safety of suprachoroidal triamcinolone acetonide injectable suspension (CLS-TA) among patients with macular oedema (ME) secondary to non-infectious uveitis (NIU).MethodsPatients with uveitic ME were treated with suprachoroidal CLS-TA at baseline and week 12 of the Efficacy and Safety of Suprachoroidal CLS-TA for Macular Edema Secondary to Noninfectious Uveitis: Phase 3 Randomized Trial (PEACHTREE) study. Time to rescue was evaluated over 24 additional weeks for MAGNOLIA. Safety data, visual acuity and retinal central subfield thickness (CST) reduction were also evaluated. Of the 53 eligible patients (46 CLS-TA and 7 control), 33 patients were enrolled (28 CLS-TA and 5 control).ResultsOver the entire 48-week period for PEACHTREE and MAGNOLIA, the median time to rescue therapy was 257 days versus 55.5 days for the CLS-TA and sham-control arms, respectively. Of 28 CLS-TA treated patients who participated in MAGNOLIA, 14 (50%) did not require rescue therapy through approximately 9 months after the second treatment. Among CLS-TA patients not requiring rescue, there was a mean gain of 12.1 letters and mean CST reduction of 174.5 µm at week 48. No serious adverse events related to study treatment were observed.ConclusionApproximately 50% of patients did not require additional treatment for up to 9 months following the last CLS-TA administration.

Necrotizing scleritis is primarily considered an anterior segment disease, often (but not always) affecting patients with underlying autoimmune diagnoses such as rheumatoid arthritis.1 Histopatholo...

OBJETIVO: Identificar los factores de riesgo del cáncer de cuello uterino. DISEÑO: Se realizó un estudio retrospectivo descriptivo de enero de 1995 a marzo de 1996, de pacientes que consultaron al Departamento de Ginecología-Obstetricia del Hospital Regional Docente "Las Mercedes" de Chiclayo. Se revisó las fichas de Registro de Cáncer Ginecológico, incluyéndose 110 pacientes con diagnóstico de cáncer de cuello uterino. La patología fue confirmada con estudio histológico de biopsia de cuello uterino en el 95% de los casos. RESULTADOS. -El promedio de edad fue de 47 años. El 38,2% fue conviviente. El 41% procedió de Chiclayo y distritos. 68 mujeres nunca tuvieron Papanicolaou previo. El promedio de edad de inicio de relaciones sexuales fue de 18,4 años. 21 % tuvo, más de un compañero sexual. El promedio de hijos por paciente fue de 6,4. 77,3% fueron cáncer avanzado (II, III y IV). El inicio de las relaciones sexuales a temprana edad y el número elevado de hijos son los factores de riesgo encontrados. El número de compañeros sexuales en ambos sexos debe ser evaluado. CONCLUSIONES: Esta neoplasia es un problema de salud pública: el 77,3% son estadíos avanzados, sólo el 41 % procede de Chiclayo y 61,8% nunca tuvo Papanicolaou previo.

To report on the accuracy of the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes for identifying patients with polymyalgia rheumatica (PMR) and concurrent noninfectious inflammatory ocular conditions in a large healthcare organization database.Queries for patients with PMR and uveitis or scleritis were executed in two general teaching hospitals' databases. Patients with ocular infections or other rheumatologic conditions were excluded. Patients with PMR and ocular inflammation were identified, and medical records were reviewed to confirm accuracy.The query identified 10,697 patients with the ICD-9-CM code for PMR and 4154 patients with the codes for noninfectious inflammatory ocular conditions. The number of patients with both PMR and noninfectious uveitis or scleritis by ICD-9-CM codes was 66. On detailed review of the charts of these 66 patients, 31 (47%) had a clinical diagnosis of PMR, 43 (65%) had noninfectious uveitis or scleritis, and only 20 (30%) had PMR with concurrent noninfectious uveitis or scleritis confirmed based on clinical notes.While the use of ICD-9-CM codes has been validated for medical research of common diseases, our results suggest that ICD-9-CM codes may be of limited value for epidemiological investigations of diseases which can be more difficult to diagnose. The ICD-9-CM codes for rarer diseases (PMR, uveitis and scleritis) did not reflect the true clinical problem in a large proportion of our patients. This is particularly true when coding is performed by physicians outside the area of specialty of the diagnosis.

Uveitis is a group of inflammatory ocular conditions that cause significant visual morbidity around the world. Many of the cases of blindness secondary to uveitis can be avoided with adequate and aggressive management of the intraocular inflammation. Steroids have been utilized in the treatment of noninfectious uveitis for more than 60 years, but their chronic use is associated with severe ocular and systemic side-effects. Ophthalmologists are often not familiar with the systemic steroid-sparing agents available for the management of ocular inflammation and depend primarily on the use of corticosteroids. In this article, we review the most common agents utilized in the treatment of uveitis and their side-effect profiles.

To determine the impact of evaporation on preocular aqueous tear (AT) loss in normal subjects (controls) and patients with keratoconjunctivitis sicca (KCS).Eighteen patients (32 eyes) with KCS with or without associated meibomian gland dysfunction (MGD) and 11 sex-matched controls had AT evaporation determined between relative humidity (RH) of 20% and 45% using an evaporometer. AT volume, flow, and turnover were determined with a fluorophotometer.Evaporative rates increased significantly when the RH was changed from 40%-45% to 20%-25% (P.001). This change was similar in all groups and on average accounted for a 99.43% increase. There were no statistically significant differences in evaporative rate between controls, the KCS alone group, and the KCS/MGD group. Dry eye patients exhibited a decreased tear turnover when compared to controls. Evaporative contribution to tear loss at 40%-45% RH was 23.47% for controls, 30.99% for "classic" KCS patients, and 25.44% for KCS/MGD patients. At 20%-25% RH, the evaporative contribution was 41.66% for controls, 57.67% for classic KCS patients, and 50.28% for KCS/MGD patients.RH significantly impacts evaporation regardless of the presence of dry eye disease and probably accounts for the increased dry eye symptoms in people (controls and dry eye patients) in conditions of low RH (eg, deserts, airplane cabins, cold dry seasons). Contribution of evaporation to tear loss tends to be higher than previously described. The percent contribution is dependent on environmental conditions such as RH. There was a trend toward increased contribution to AT loss in dry eye patients vs controls, but statistical significance was not reached.