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Results Of 234 enrolled patients, 210 (89.7%) completed the study. Patients received 6.1 (mean) ranibizumab injections over 24 months. Approximately 42% of patients had 7 or more visits at which ranibizumab was not administered, although they had experienced a VA loss of more than 5 letters, indicating either an undertreatment or that factors other than VA loss were considered for retreatment decision by the investigator. The most frequent ocular AEs (study eye) were retinal hemorrhage (12.8%; 1 event related to study drug), cataract (11.5%; 1 event related to treatment procedure), and increased intraocular pressure (6.4%; 1 event related to study drug). Cataract reported as serious due to hospitalization for cataract surgery occurred in 2.6% of patients; none was suspected to be related to study drug or procedure. Main nonocular AEs were hypertension and nasopharyngitis (9.0% each). Arterial thromboembolic events were reported in 5.6% of the patients. Five (2.1%) deaths occurred during the study, none related to the study drug or procedure. At month 24, mean BCVA declined by 4.3 letters from the SECURE baseline. Conclusions The SECURE study showed that ranibizumab administered as per a VA-guided flexible dosing regimen recommended in the European ranibizumab SmPC at the investigator's discretion was well tolerated over 2 years. No new safety signals were identified in patients who received ranibizumab for a total of 3 years. On average, patients lost BCVA from the SECURE study baseline, which may be the result of disease progression or possible undertreatment. Link to Full Text ( Original article available on-line 25.09.2012 via Science Direct Athens log in required) Intravitreal aflibercept (VEGF Trap-Eye) in wet age-related macular degeneration Reference: Ophthalmology, published early online on 17 October 2012 Abstract: Objective Two similarly designed, phase-3 studies (VEGF Trap-Eye: Investigation of Efficacy and Safety in Wet AMD [VIEW 1, VIEW 2]) of neovascular age-related macular degeneration (AMD) compared monthly and every-2-month dosing of intravitreal aflibercept injection (VEGF Trap-Eye; Regeneron, Tarrytown, NY, and Bayer HealthCare, Berlin, Germany) with monthly ranibizumab. Design Double-masked, multicenter, parallel-group, active-controlled, randomized trials. Participants Patients (n = 2419) with active, subfoveal, choroidal neovascularization (CNV) lesions (or juxtafoveal lesions with leakage affecting the fovea) secondary to AMD. Intervention Patients were randomized to intravitreal aflibercept 0.5 mg monthly (0.5q4), 2 mg monthly (2q4), 2 mg every 2 months after 3 initial monthly doses (2q8), or ranibizumab 0.5 mg monthly (Rq4). Main Outcome Measures The primary end point was noninferiority (margin of 10%) of the aflibercept regimens to ranibizumab in the proportion of patients maintaining vision at week 52 (losing
FDA approves 'first nonsurgical treatment' for vitreomacular adhesion The US Food and Drug Administration (FDA) reports the approval of ocriplasmin for the treatment of symptomatic vitreomacular adhesion (VMA). The safety and efficacy of the drug have been previously assessed in two randomized controlled trials published in the New England Journal of Medicine, which involved over 600 patients with the condition, and showed a significantly higher rate of VMA resolution after ocriplasmin versus placebo. (abstract to this trial was referred to in August’s Newsletter) Link to abstract Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Centre for Drug Evaluation and Research said, "Today's approval represents a significant advancement in treatment for patients with symptomatic VMA. Those with this sight-threatening disease now have a non-surgical treatment option." "Ocriplasmin is a recombinant protease with activity against fibronectin and laminin, components of the vitreoretinal interface," explain Julia Haller (Willis Eye Institute, Philadelphia, Pennsylvania) and colleagues, authors of the clinical trials. The alternative treatment for VMA is vitrectomy, notes the FDA statement, a surgical procedure that involves cutting the vitreous gel in the eye and sucking it out. In Haller et al's study, vitreomacular adhesion resolved in 26.5% of 464 VMA patients treated with a single injection of ocriplasmin, compared with 10.1% of 188 placebo-injected patients. In addition, the research team found that total posterior vitreous detachment was significantly more frequent among patients who had received ocriplasmin than those who had received placebo, at 13.4% versus 3.7%. However, the researchers report a higher rate of ocular adverse events in ocriplasmin-treated eyes over the 6-month follow-up period, including vitreous floaters, photopsia (flashes of light), injection-related eye pain, blurred or unclear vision, and conjunctival bleeding. Despite this, the rate of serious adverse events was similar in both groups. "Intravitreal injection of ocriplasmin was superior to injection of placebo in altering the vitreoretinal interface of affected eyes, although it was accompanied by some, mainly transient, ocular adverse events," conclude Haller and coinvestigators. New major UK eye care institution joins Map of Medicine The College of Optometrists will join the Royal College of Ophthalmologists, to accredit National Eye Care Pathways. The first joint accreditations are expected early next year. PPV safe for irradiated uveal melanoma Ophthalmology Times Europe…... Pars plana vitrectomy is safe to use on patients with plaqueirradiated uveal melanoma, according to a study in the Archives of Ophthalmology. The retrospective case series, headed by Dr Alok S. Bansal, Department of Immunology, St Helier Hospital, Carshalton, Surrey, UK, included 47 eyes of 47 patients with plaqueirradiated posterior uveal melanoma who underwent PPV for vitreous haemorrhage. The primary outcome measures included rates of intraocular melanoma dissemination, extrascleral extension of melanoma, local melanoma recurrence and systemic melanoma metastasis after PPV. No cases of intraocular melanoma dissemination or extrascleral extension of melanoma were found. Local choroidal melanoma recurrence was found in one patient and was successfully managed with transpupillary thermotherapy. After a mean interval of five years after plaque radiotherapy, four patients experienced systemic melanoma metastasis. The management of vitreous haemorrhage using PPV is safe and doesn’t increase the risk of intraocular, local, orbital or systemic dissemination of the tumour in patients with uveal melanoma Link to abstract of study in Archives of Ophthalmology (full text available to read in Eye Library) UpToDate The following topics have recently been updated on UpToDate! Select the titles to access full topic (only available via Royal Wolverhampton Internet) Allergic Conjunctivitis (updated 04/10/2012) Traumatic Hyphema: Clinical Features and Management (updated 07/09/2012) Tubulointerstital nephritis and Uveitis (TINU Syndrome) (Updated 08/09/2012) Open angle glaucoma: Treatment (updated 25/09/2012) Clinical Features and diagnosis of Fabry Disease (updated 26/09/2012) Retinal vasculitis associated with Systematic Disorders and Infections (updated 29/08/2012) Etiology and Evaluation of Microcephaly in Infants and young Children (updated 10/09/2012) Visual Development and Visual Assessment in Infants and Children (updated 07/08/2012)
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