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Grant
Agency: Cordis | Branch: FP7 | Program: CP-FP | Phase: HEALTH.2012.2.4.4-1 | Award Amount: 5.57M | Year: 2012

This project will undertake preclinical and clinical research of the Orphan Drug Polihexanide (PHMB). The main objective is to provide a safe and effective drug for the treatment of the rare ocular disease Acanthamoeba keratitis (AK) tested according to international regulatory standards. This debilitating infectious disease is caused by a free living protozoan which, in the absence of treatment, can have catastrophic consequences such as severe pain, visual loss and eye enucleation. There are no approved drugs to treat this disease. After Orphan Drug Designation Protocol Assistance was requested from the European Medicines Agency on our drug development research plan. The proposed protocol incorporates the EMA advice and will include a non-clinical phase, a double-blind placebo controlled Phase I trial and a randomised double-blind, active controlled, parallel groups Phase 3 study (efficacy and safety therapeutic confirmatory study). The primary deliverables will be: 1) experimental scientific evidence on the quality, safety and efficacy of PHMB to provide the basis for a Marketing Authorisation within 5 years; 2) recommendations aiming to improve clinical practices in the management of AK based on the efficacy and safety evidence. ODAK is an industry led project mobilising the critical mass of industrial, pharmaceutical and academic expertise. needed to develop and optimise therapeutic approaches to alleviate the severe negative impacts of AK on the health and quality of life of patients. In particular, through identifying optimal PHMB formulations and recommending the best dose-benefit treatment regimes. ODAK directly contributes to the International Rare Diseases Research Consortium goal towards 200 new therapies. An estimated 95% of the total estimated EU contribution to the project will go to industrial partners (of this 32% goes to SMEs). The industrial strength assures a rapid translation of research to market application.


Grant
Agency: Cordis | Branch: FP7 | Program: CP-FP | Phase: HEALTH.2011.2.4.3-1 | Award Amount: 7.76M | Year: 2012

Diabetic retinopathy (DR), the leading cause of blindness among working-age individuals in developed countries has been classically considered to be a microcirculatory disease of the retina. However, there is growing evidence to suggest that retinal neurodegeneration is an early event in the pathogenesis of DR. For this reason, it is reasonable to hypothesize that therapeutic strategies based on neuroprotection will be effective not only in preventing or arresting retinal neurodegeneration but also in preventing the development and progression of the early stages of DR (ie. microaneurysms and/or retinal thickness). EUROCONDOR (European Consortium for the Early Treatment of Diabetic Retinopathy) is a solid and well balanced consortium (ophthalmologists, endocrinologists, basic researchers) which has been created in order to implement the first clinical trial using eye drops for treatment of the early stages of DR. The participants are top leaders in their field and central readings will be performed by the Coordinating Centre of the European Vision Institute Clinical Research Network (EVICR.Net). The main objectives of the project are the following: Primary objective: To assess whether the selected neuroprotective drugs (brimonidine and somatostatin) administered topically are able to prevent or arrest neurodegeneration, as well as the development and progression of the early stages of DR. Secondary objectives: 1) To determine the prevalence of functional abnormalities related to neurodegeneration in those patients without or with minimal microvascular damage under ophthalmoscopic examination. 2) To compare the effectiveness of the selected drugs. 3) To evaluate the local and systemic adverse effects of the selected drugs. 4) To identify those patients most prone to progressive worsening (characterization of phenotypes and circulating biomarkers). 5) To determine the molecular mechanisms by which the selected drugs exert their beneficial effects.


Age-related macular degeneration (AMD) is the worlds most important age-related blinding disorder. The current proposal utilises epidemiological data describing clinical phenotype, molecular genetics, lifestyle, nutrition, and in-depth retinal imaging derived from existing longitudinal European epidemiological cohorts and biobanks to provide three major insights needed for long-lasting prevention and therapy for AMD: (a) the development of robust algorithms utilising genetic and non-genetic risk factors to identify personalised risks of developing advanced wet and dry AMD; (b) the identification of novel biomarkers for further stratification of disease risks. New insights from (a)\(b) will be used to elaborate preventive medical recommendations for highrisk subgroups of AMD patients; and (c) the identification of molecular drivers/biological pathways relevant for onset and progression of advanced AMD that will be used to identify and validate new therapeutic targets. Key deliverables are: 1. Determination of AMD frequency in Europe, and assessment of AMD risk for phenotypical, genetic, environmental, and biochemical risk factors and their interaction. (WP1-3) 2. Development of a web-based prediction model for personalised risk assessment of AMD based on integration of risk profiles derived from retinal imaging, molecular genetics, assessment of lifestyle, and biochemical testing. (WP4) 3. Modelling and functional characterisation of pathophysiological pathways identified from integrated analysis of current knowledge and the above risk profiles. (WP5) 4. Experimental testing and interpretation of pathophysiological consequences of risks at the molecular level. (WP6) 5. An extension and refinement of the prediction model (WP4) based on work in WP5 and WP6 to generate clinical guidelines for the medical management of high-risk subgroups of patients with AMD. (WP7) 6. Promotion and dissemination of newly gained knowledge towards AMD prevention and therapy development


SYLMAR, Californie, et LAUSANNE, Suisse--(BUSINESS WIRE)--Second Sight Medical Products, Inc. (Nasdaq : EYES) (« Second Sight »), société qui conçoit, développe et commercialise des prothèses visuelles implantables permettant de restituer une partie de la fonction visuelle chez des patients non-voyants, annonce aujourd’hui que le NHS, système de santé publique du Royaume-Uni, remboursera le traitement de son système de prothèse rétinienne, l’« œil bionique » Argus® II pour des patients aveugles atteints de rétinite pigmentaire (RP). Ce remboursement est une première au Royaume-Uni et fait suite à la recommandation positive d’un groupe de conseillers aux autorités de financement des soins de santé du Gouvernement britannique pour les services spécialisés en Angleterre. NHS England a annoncé que certains patients atteints de cécité sévère due à une rétinite pigmentaire pourront avoir accès à l’Argus II, premier et unique traitement au monde ayant obtenu les autorisations commerciales en Europe et aux Etats-Unis pour ce type de cécité. Il sera disponible dans deux centres d’implantation : le Manchester Royal Eye Hospital pour le nord de l’Angleterre et le Moorfields Eye Hospital à Londres. Ces deux hôpitaux et la société Second Sight mettront sur pied le suivi, la rééducation et le support adéquat aux patients recevant un implant Argus II. Le système Argus II sera financé via le programme Commissioning through Evaluation (CtE), un programme spécialement conçu pour donner l’accès à des traitements prometteurs tout en collectant davantage de données cliniques dans le cadre d’un programme d’évaluation officiel. Argus II est déjà remboursé en France via le « Forfait Innovation », programme de prise en charge dérogatoire et transitoire, dans le cadre duquel les patients peuvent bénéficier du traitement avec Argus II. Will McGuire, président et PDG de Second Sight, affirme : « Il s’agit d’une étape importante pour Second Sight car nous sommes la seule société capable de démontrer un bilan bénéfice-risque favorable sur le long terme, jusqu’à cinq ans après implantation pour certains patients atteints de RP. On sait que le NHS England est soumis à d’importantes pressions financières et également très sélectif dans l’adoption de technologies innovantes – qui doivent démontrer un rapport qualité-prix suffisant. Nous nous attendons à ce que cette décision soit considérée par d’autres services de soins de santé dans le monde. » Le Professeur Paulo Stanga du Manchester Royal Eye Hospital, de l’Université de Manchester et du Manchester Vision Regeneration (MVR) Lab au NIHR/Wellcome Trust Manchester Clinical Research Facility, qui a joué un rôle crucial pour que les patients aient accès à l’« œil bionique » au NHS, déclare : « Je suis ravi que notre étude sur ce dispositif innovant ait pu fournir la preuve pour soutenir la décision du NHS England de financer l’« œil bionique » pour la première fois. J'ai été en première ligne pour constater à quel point cette technologie était bénéfique et changeait la vie de patients atteints de RP et complètement non-voyants. Nous vivons dans un monde visuel, il est donc rassurant et enthousiasmant pour une personne entièrement aveugle de récupérer des perceptions visuelles. Il s’agit d’une décision formidable. Pour les familles de patients, c’est également un traitement améliorant les conditions de vie, car cela peut signifier moins de dépendance pour leurs proches. » Le Professeur Lyndon da Cruz, MD, PhD, chirurgien consultant de la rétine au Moorfields Eye Hospital NHS Foundation Trust qui, avec le Professeur Stanga, a défendu pendant plus de cinq ans le remboursement du traitement par le NHS, déclare : « Pour les patients souffrant de RP avec une perte de vision profonde, les bénéfices d’Argus II à long terme dans la restauration d’une vision utile sont susceptibles de changer leur vie. Le plus enthousiasmant est peut-être la possibilité d’Argus II à augmenter la vision fonctionnelle des patients. Avec l’Argus II, certains patients peuvent effectuer des tâches qui seraient impossibles sans le dispositif. Nos travaux à Moorfields ont montré que ces changements perdurent plusieurs années après l’implantation pour certains patients et représentent pour eux un traitement stable et efficace. Ce remboursement souligne l’ambition du Gouvernement de faire du Royaume-Uni un chef de file mondial en matière d’innovation médicale. » Second Sight poursuit ses travaux novateurs avec l’objectif de restaurer la vision chez des patients souffrant de n’importe quel type de cécité incurable. La société continue ses recherches au Royaume-Uni sur la dégénérescence maculaire liée à l'âge (DMLA). En 2015, le Manchester Royal Eye Hospital en Angleterre a équipé d’implants plusieurs patients atteints de DMLA. La maladie est plus complexe que la RP. Aux États-Unis, Second Sight travaille avec l'Université de Californie Los Angeles (UCLA), qui a récemment effectué une implantation et l’activation réussies d’un stimulateur cortical visuel sur un sujet humain. Le système Argus II de Second Sight produit une stimulation électrique permettant de contourner les cellules rétiniennes mortes et de stimuler les cellules viables restantes, ce qui induit une perception visuelle chez des personnes atteintes de dégénérescence rétinienne périphérique sévère à majeure. Le dispositif Argus II fonctionne en convertissant des images capturées par une caméra vidéo miniature montée sur les lunettes du patient en une série de petites impulsions électriques transmises par liaison sans fil à un faisceau d'électrodes implantées à la surface de la rétine. Ces impulsions visent à stimuler les dernières cellules vivantes de la rétine, entraînant une perception de motifs lumineux dans le cerveau. Le patient apprend ensuite à interpréter ces motifs visuels, récupérant ainsi une certaine fonction visuelle. Argus II est la première rétine artificielle à avoir reçu une autorisation au niveau mondial. Elle est déjà disponible dans des centres approuvés au Canada, en France, en Allemagne, en Italie, aux Pays-Bas, en Arabie Saoudite, en Espagne, en Suisse, en Turquie, au Royaume-Uni et aux États-Unis. Second Sight a pour mission de développer, fabriquer et commercialiser des prothèses visuelles implantables afin de permettre à des personnes non-voyantes d’acquérir une plus grande autonomie. Second Sight développe, conçoit et commercialise le système de prothèse rétinienne Argus® II. Le recrutement des patients pour un essai clinique visant à évaluer l’innocuité et l’utilité d’Argus II chez des personnes atteintes de la forme « sèche » de dégénérescence maculaire liée à l'âge est terminé. Second Sight développe également la prothèse corticale visuelle Orion™ I visant à restaurer une vision chez des personnes dont la cécité provient de causes autres que des pathologies évitables ou curables. Le siège social américain de la société et implanté à Sylmar, en Californie, et son siège social européen est à Lausanne, en Suisse. Pour plus d’informations : www.secondsight.com. Ce communiqué de presse contient des énoncés prospectifs au sens de la Section 27A de la loi Securities Act de 1933, sous sa forme amendée, et de la Section 21E de la loi Securities Exchange and Exchange Act de 1934, sous sa forme amendée, qui sont censés être couverts par la « règle refuge » créée par ces sections. Tous les énoncés formulés dans ce communiqué qui ne sont pas basés sur des faits historiques sont des « énoncés prospectifs ». Ces énoncés peuvent être identifiés par des mots tels que « estime », « anticipe », « projette », « prévoit », « prévu », « cherche à », « pourrait », « fera », s’attend à », « a l’intention de », « pense que », « devrait » et des expressions similaires, ou leurs versions négatives, et sont également susceptibles d’être identifiés par leur contexte. Tous les énoncés traitant des performances d'exploitation, d’événements ou développements dont la survenue future est attendue ou anticipée par Second Sight sont des énoncés prospectifs. Bien que la direction ait fondé tous les énoncés prospectifs contenus dans le présent communiqué sur ses attentes actuelles, les renseignements sur lesquels sont basées lesdites attentes peuvent être amenés à changer. Les énoncés prospectifs comportent des incertitudes et des risques inhérents susceptibles de faire varier sensiblement les résultats réels par rapport à ceux indiqués dans les énoncés prospectifs en raison de divers facteurs, dont les risques et incertitudes décrits dans les sections « Facteurs de risque » et « Analyse par la direction de la situation financière et des résultats d'exploitation » de notre rapport annuel sur formulaire 10-K déposé le 11 mars 2016 et modifié le 8 août 2016, et de nos autres rapports déposés à l’occasion auprès de la SEC (Commission américaine de contrôle des opérations boursières). Nous vous conseillons vivement de tenir compte de ces risques et incertitudes lors de l’évaluation de nos énoncés prospectifs. Nous déconseillons aux lecteurs de se fier indûment à l’un quelconque de ces énoncés prospectifs, qui ne valent qu’à la date à laquelle ils sont formulés. Sauf si les lois fédérales sur les valeurs mobilières l’exigent, nous rejetons toute obligation ou engagement à publier des mises à jour ou révisions d’un quelconque énoncé prospectif formulé dans les présentes (ou ailleurs) pour refléter un quelconque changement au niveau de nos attentes à cet égard ou un quelconque changement au niveau des événements, situations ou circonstances sur lesquels un tel énoncé est basé.


Grant
Agency: Cordis | Branch: FP7 | Program: CP-FP | Phase: HEALTH.2012.2.4.4-1 | Award Amount: 7.74M | Year: 2012

Neovascular glaucoma (NVG) is a very aggressive and rare type of glaucoma: yet, it contributes disproportionately to blindness from all eye diseases. NVG is also the second most common cause for the removal of the eye-ball across all eye diseases, usually because of intractable pain. The major cause of NVG is Ischaemic Central Retinal Vein Occlusion (CRVO) leading to neovascularisation, obstruction of aqueous humour outflow and increased intraocular pressure. Todays therapeutic approaches are insufficient: they include destruction of the retina by coagulation, or off-label anti-VEGF injection into the eye. It is proposed to develop a better treatment by assessing the topical administration of Aganirsen: it is an antisense oligonucleotide able to interrupt the production of Vascular Endothelial Growth Factor, which plays a major role in the pathogenesis of NVG. Aganirsen is developed by GENE SIGNAL, a SME with expertise in topical ophthalmic treatments for orphan diseases, and manufactured by AMATSI. Under the coordination of the Mainz University Medical Center, a Phase II/III randomised, double-masked, 3-group, placebo-controlled trial (STRONG) is therefore presented to assess Aganirsens efficacy in reducing the rate of anterior and posterior segment neovascularisation and NVG development after CRVO. Involving 333 subjects within more than 30 clinical sites, the study is operationalized via a disease specific network (EVICR.net) and a contract research organization managed by GENE SIGNAL. The study aims at assessing a new therapeutic approach for NVG for which conditional authorization will be sought at the end of the project. STRONG also delivers new insights into the natural course of the disease and its risk factors, analysing one of the largest patient cohorts ever. It also allows for a novel classification of NVG, yields novel image analysis tools, and proposes biomarkers able to differentiate between high- and low-risk patients and drug responders.


News Article | November 20, 2016
Site: www.prnewswire.co.uk

Moorfields Eye Hospital Dubai, one of the Middle East's leading eye hospitals and a branch of the world renowned Moorfields Eye Hospital in London, has successfully performed a highly complex surgical procedure in which a team removed a large tumour from behind a 26 year old Arab woman's eye. The tumour was causing the eye to bulge forward and was threatening her vision, by compressing the nerve at the back of the eye. It was a large benign tumour measuring 2.2 X 2.1 X 1.2 cm and though it did not spread to other parts of the body it continuously increased in size to compress the surrounding tissues. The tumour was completely removed during the operation where a 'window' was cut through the bone at the outer side of the eye socket, a lateral orbitotomy, leaving the eye intact. She was discharged the following day, with her vision fully restored. Dr. Yassir Abou-Rayyah, Consultant Ophthalmic & Oculoplastic Surgeon at Moorfields Eye Hospital Dubai, who led the surgical team, commented: "This was a very severe case and a very complex surgical procedure to remove the massive tumour and relieve the pressure on the optic nerve and the forward bulging of the eye. In fact, the bulge was the symptom that revealed the presence of the tumour and so it was an important part of the diagnosis. The pressure on the optic nerve was more dangerous and a threat to the vision of the patient. We believe this is the first time that this procedure has been carried out in the UAE and we are delighted with the patient's recovery and response." Orbital tumours may present with a range of symptoms, from gradual, painless fogging or dimming of vision to bleeding that can cause sudden visual loss. If the tumour is large, there may be proptosis, or eye bulging with limitation of eye movements, as in this case. Benign tumours are only treated if there is a complication like vision loss and surgical excision of the tumour is only necessary for extreme cases. Tumours often go undiscovered unless or until they make the eye stick out or affect the vision. Moorfields Eye Hospital Dubai (MEHD) is the first overseas branch of Moorfields Eye Hospital NHS Foundation Trust, the oldest and one of the largest centres for ophthalmic treatment, teaching and research in the world. Located at the Al Razi Medical Complex in Dubai Health Care City, the facility provides day case surgery and outpatient diagnostic and treatment services, for a variety of surgical and non-surgical eye conditions. MEHD will also raise standards for research and teaching in the region. MEHD is owned and managed by the NHS Foundation Trust, and maintains close links with London, to ensure that patients in the GCC receive the best eye care treatment in the world. Issued on behalf of Moorfields Eye Hospital Dubai by WPR.


A team from Moorfields Eye Hospital Dubai has successfully treated an elderly patient from Saudi Arabia, restoring the patient's sight in one eye after he spent 18 months with no sight in either eye. 83 year-old Mr. Hassan Al Shaikh Ahmad is now mobile and independent again, after a series of procedures performed in Dubai by Dr. Muhammad Irfan Khan, Consultant Ophthalmologist with a special interest in strabismus and cataract. The patient had a very severe corneal scar in the right eye and his left eye had a convergent squint (so severe that the cornea was invisible) and cataract. The right eye was inoperable and so the team focused on treating the left eye with a two-stage surgical procedure, first to correct the squint and then to perform the cataract surgery which was necessary after the cataract had been discovered during the squint surgery. The first phase strabismus surgery by Dr. Irfan was successful and once the left eye had been straightened enough to allow further detailed examination of the eye, a significant cataract was discovered. This led to the second stage of the treatment, following a month of recovery after the squint surgery, in which Dr. Irfan performed the cataract surgery. Dr. Muhammad Irfan Khan, Consultant Ophthalmologist at Moorfields Eye Hospital Dubai, commented: "This was a particularly challenging elderly patient presenting with serious problems in both eyes, and revealing additional problems once we had been able to perform a full examination of the eyes. Unfortunately, we were unable to treat his right eye but the results of the treatment on the left eye have been successful and the team is delighted with Mr. Hassan's progress and recovery, allowing him to lead a normal life after living without vision for 18 months. He is now walking independently and performing his daily activities and routine, which is so important for every patient and especially those older patients." Mr. Hassan Al Shaikh Ahmad, the 83 year-old patient from Saudi Arabia added: "I cannot express my gratitude enough to Dr. Irfan and the team at Moorfields; I am so happy to be able to walk again and to do things independently without the help of others." Strabismus (squint or crossed eyes) is a misalignment of the eyes, inward or outward, and can only be treated with vision therapy or surgery. A cataract is a clouding of the eye's natural lens, which lies behind the iris and the pupil. Cataracts are the most common cause of vision loss in people over the age of 40 and are the principal cause of blindness in the world. Most cataracts are related to aging and they are very common in older people. Dr. Irfan Khan is one of the few ophthalmologists in the world with dual training from United Kingdom and Canada. He is subspecialty trained in the management of all aspects of Paediatric Ophthalmology and Ocular Motility including; Paediatric Cataracts, Paediatric Glaucoma, Retinopathy of Prematurity, Retinoblastoma, Paediatric Anterior Segment Reconstruction, common Paediatric Oculoplastics, Strabismus or Squint, Adult Strabismus (with Adjustable sutures) and Adult Cataract Surgery. He is a valuable member of the Moorfields team and holds clinics in both Moorfields Eye Hospital Dubai and Al Jalila Children's Specialty Hospital. Moorfields Eye Hospital Dubai (MEHD) is the first overseas branch of Moorfields Eye Hospital NHS Foundation Trust, the oldest and one of the largest centres for ophthalmic treatment, teaching and research in the world. Located at the Al Razi Medical Complex in Dubai Health Care City, the facility provides day case surgery and outpatient diagnostic and treatment services, for a variety of surgical and non-surgical eye conditions. MEHD will also raise standards for research and teaching in the region. MEHD is owned and managed by the NHS Foundation Trust, and maintains close links with London, to ensure that patients in the GCC receive the best eye care treatment in the world. Issued on behalf of Moorfields Eye Hospital Dubai by WPR.


Mitry D.,Moorfields Eye Hospital NHS Foundation Trust
Cochrane database of systematic reviews (Online) | Year: 2013

Branch retinal vein occlusion (BRVO) is one of the most common occurring retinal vascular abnormalities. The pathogenesis of BRVO is thought to involve both retinal vein compression and damage to the vessel wall, possibly leading to thrombus formation at sites where retinal arterioles cross retinal veins. The most common cause of visual loss in patients with BRVO is macular oedema (MO). Grid or focal laser photocoagulation has been shown to reduce the risk of visual loss and improve visual acuity (VA) in up to two thirds of individuals with MO secondary to BRVO, however, limitations to this treatment exist and newer modalities have suggested equal or improved efficacy. Recently, antiangiogenic therapy with anti-vascular endothelial growth factor (anti-VEGF) has been used successfully to treat MO resulting from a variety of causes. As elevated intraocular levels of VEGF have been demonstrated in patients with retinal vein occlusions there is a strong basis for the hypothesis that anti-VEGF agents may be beneficial in the treatment of vascular leakage and MO. To investigate the efficacy and safety of intravitreal anti-VEGF agents for preserving or improving vision in the treatment of MO secondary to BRVO. We searched CENTRAL of any prior treatment.


Rajendram R.,Moorfields Eye Hospital NHS Foundation Trust
Cochrane database of systematic reviews (Online) | Year: 2012

Thyroid eye disease is an autoimmune inflammatory condition of the orbital and periorbital tissues. Orbital radiotherapy is an anti-inflammatory treatment used in the treatment of active thyroid eye disease. It is administered as an outpatient procedure in 10 to 12 fractionated doses. To assess the effectiveness and adverse events of orbital radiotherapy in thyroid eye disease. The effectiveness was dependent on the level of 'success' of the intervention predefined in each randomised controlled trial (RCT). We searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (The Cochrane Library 2012, Issue 2), MEDLINE (January 1950 to March 2012), EMBASE (January 1980 to March 2012), Latin American and Caribbean Literature on Health Sciences (LILACS) (January 1982 to March 2012), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov (www.clinicaltrials.gov) and the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not restrict the electronic searches for trials by date or language. We last searched the electronic databases on 12 March 2012. We screened reference lists of reports of included studies, other reviews and book chapters to find additional trials. We contacted trial investigators and experts in the field to identify additionally published studies. We included RCTs of orbital radiotherapy versus sham radiotherapy or other interventions enrolling adults, with a minimum of three months' follow-up and an endpoint of two years or less post treatment. Two review authors independently assessed trial quality and extracted data. Trial authors were contacted for missing data. The risk ratio was used for our primary outcome. For our secondary outcomes, the odds ratio and mean difference were reported where possible. We obtained full-text copies of nine potential studies and included five trials with a total of 244 participants in this review. Orbital radiotherapy was compared to sham radiotherapy in two studies and to glucocorticoids in three studies, as a monotherapy or combination therapy. There was heterogeneity (as defined in our protocol) of trial outcome measures. Our primary outcome of a composite score was used in the two trials comparing radiotherapy versus sham radiotherapy and showed a risk ratio of success of 1.92 (95% confidence interval (CI) 1.27 to 2.91) in favour of orbital radiotherapy. The primary outcome was not used in the other three trials. This review found that orbital radiotherapy is more effective than sham radiotherapy for the treatment of mild-to-moderate thyroid eye disease. In a single trial no difference between radiotherapy and steroid monotherapy was found. A meta-analysis of our secondary outcome of disease severity was not possible but results from individual trials suggest a better outcome with combination treatment with steroids versus steroids alone. No significant changes in quality-of-life scores following treatment with radiotherapy versus alternative treatments were found. Short-term adverse events related to radiotherapy that were reported were local and mild but long-term data were lacking and development of retinal changes following radiotherapy was not reported on.


Minakaran N.,Moorfields Eye Hospital NHS Foundation Trust
The Cochrane database of systematic reviews | Year: 2013

Thyroid associated ophthalmopathy (TAO) is the most frequent extrathyroidal manifestation of Graves' disease, affecting up to 50% of patients, and has a great impact on quality of life. Rituximab is a human/murine chimeric monoclonal antibody that targets CD20, a transmembrane protein expressed on the surface of pre-B and mature B lymphocytes, but not on stem cells, pro-B lymphocytes or plasma cells. Preliminary work has shown that blocking the CD20 receptor on B-lymphocytes with rituximab affects the clinical course of TAO, by reducing inflammation and the degree of proptosis. The aim of this review was to investigate the effectiveness and safety of rituximab for the treatment of TAO. We searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (The Cochrane Library 2013, Issue 3), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE, (January 1950 to April 2013), EMBASE (January 1980 to April 2013), Latin American and Caribbean Literature on Health Sciences (LILACS) (January 1982 to April 2013), OpenGrey (System for Information on Grey Literature in Europe) (www.opengrey.eu/), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov (www.clinicaltrials.gov), the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en) and the EU Clinical Trials Register (www.clinicaltrialsregister.eu). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 15 April 2013. We manually searched references of review articles and used the Science Citation Index to identify additional studies citing trials. We contacted the lead investigators of relevant trials on ClinicalTrials.gov and the WHO ICTRP for information and data from as yet unpublished clinical trials. We contacted experts in the field for information about any ongoing trials. We contacted the manufacturers of rituximab for details of any sponsored trials. We sought to include randomised controlled trials (RCTs) of rituximab treatment by intravenous infusion for the treatment of patients with TAO, compared with placebo or intravenous glucocorticoid treatment. Two review authors independently scanned titles and abstracts, as well as independently screened the full reports of the potentially relevant studies. At each stage, the results were compared and disagreements were solved by discussion. No studies were identified that met the inclusion criteria. There are three ongoing studies which are likely to meet inclusion criteria once published, and thus be included in future updates of this review. There is currently insufficient evidence to support the use of rituximab in patients with TAO. There is a need for large RCTs, investigating rituximab versus placebo or corticosteroids in patients with active TAO to make adequate judgement on the efficacy and safety of this novel therapy for this condition.

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