Glaucoma research at Moorfields

Size: px

Start display at page:

Download "Glaucoma research at Moorfields"

Dina Elliott
5 years ago
Views:

1 Recruiting Research Studies Glaucoma research at Moorfields Moorfields Eye Hospital wants to improve access to clinical research studies for all patients within the NHS and provide the opportunities for patients to participate in research. This is a list of research studies that are currently open and recruiting patients at Moorfields Eye Hospital. This includes information about the study, the lead consultant on the study, and the currently anticipated date that patient recruitment will end. If no end date is stated, then the study has no set end date and will continue to recruit patients for the foreseeable future. If you are interested in any of the listed studies, we advise that you approach your Moorfields consultant for more information. If you are not a Moorfields patient, you will need to be referred to Moorfields Eye Hospital by your NHS GP to be able to participate in any of these studies. For further information, please res-admin@moorfields.nhs.uk If a member of our staff thinks you might meet the specific criteria for a study, they will discuss it with you in detail. You might be approached during your visit to the hospital, or receive a letter or phone call after your visit. You will be given time to consider whether you would like to take part and what the implications will be for you. All clinical research projects are strictly monitored by our research department and regulated by national bodies. You will need to give explicit written consent if you decide you would like to take part. Version: 1 Page 1 of 6 Status: PUBLISHED Approved: 17 th August 2018 Ratified: 17 th August 2018

CLAJ1015 A prospective, double-masked, randomised, multicentre, active-controlled, parallel-group, 6-month study assessing the safety and ocular hypotensive efficacy of PG324 Opthalmic Solution

2 CLAJ1015 A prospective, double-masked, randomised, multicentre, active-controlled, parallel-group, 6-month study assessing the safety and ocular hypotensive efficacy of PG324 Opthalmic Solution compared to GANFORT in subjects with elevated intraocular pressure This is a Phase III research study of an experimental drug referred to as PG324 Ophthalmic Solution. Glaucoma is an eye condition where the optic nerve, which connects the eye to brain, becomes damaged. It can lead to loss of vision if not detected and treated early on. It usually occurs when the fluid in the eye cannot drain properly, which increases the pressure inside the eye and puts pressure on the optic nerve. Glaucoma is a common condition, but many people won't realise they have it because it doesn't always cause symptoms in the early stages. This study tests a drug for lowering of the pressure of the eye (intraocular pressure, IOP) in participants with raised IOP. Consultant: Mr Jonathan Clarke Recruitment End Date : 06/10/2018 DHIS1001 An exploratory study to determine conjunctival gene expression following glaucoma surgery Glaucoma is associated with raised pressure in the eye. Surgical treatment involves creating a drainage channel to lower the pressure. Although this is often initially successful, it fails in some patients due to scarring (closure of the channel). Anti-scarring agents are available to prevent this scarring and prolong the life of the surgery. Our understanding of the biological processes of scarring is limited and therefore with this study we aim to increase knowledge of the genes that are expressed during this very important process. This knowledge may help us design better and treatments in the future. Consultant: Mr Sumit Dhingra Recruitment End Date : 31/01/2019 Glaucoma Research at Moorfields Page 2 of 6

3 GART1047 Developing a method to describe the hill of vision in glaucoma Visual field(vf) test is one of the most important examinations in the management of glaucoma patients. Its purposes are to aid clinicians to make a diagnosis, assess how glaucoma evolves, and determine how the patient can see. However, information obtained using conventional VF test is not fully sufficient to fulfill these purposes. The field of vision is commonly represented as a hill, with the most sensitive part being the peak or point of fixation, which corresponds to the fovea in the retina. To map the VF of a patient, which allows the clinician to detect areas of poor vision, visual field is measured at different locations, which are stimulated by various light intensities. However, with the current techniques, the number of locations tested is very limited, which makes it difficult to assess the evolution of the disease with accuracy or to understand patient vision-related quality of life(qol). Increasing the number of test locations would require longer test duration, which could cause patients tiredness thus reducing the reliability of the examination. To address this issue, we are developing a new method for predicting sensitivities between the tested locations using conventional VF test without having to increase the number of test locations. The aim of this study to investigate the agreement of predicted value with the measured sensitivity from a full threshold VF test in glaucoma patients and to compare with the other methods previously reported. Consultant: David Garway-Heath & Tetsuya Togano Recruitment End Date: 01/02/2019 GART1048 POSH: Prospective observational study of glaucoma patients with disc haemorrhages. Analysis of systemic and local factors related with the presence of a new disc haemorrhage Glaucoma is the most common cause of irreversible blindness in the world. It affects the optic nerve (which connects the eye to the brain) and can progress to visual impairment at very different speeds between patients. Therefore, it would be ideal to identify characteristics that help doctors predict the patients that are more likely to progress in the short term. Some people with glaucoma develop a small bleeding in the optic nerve which has been found more frequently in patients with progression of the disease. This bleeding could be a sign that the circulation of blood is abnormal in the optic nerve and in other parts of the body like the nailbed. It has already been shown that some patients with bleedings in the optic nerve also develop bleedings in the nailbed and this might be because both receive blood from very small vessels called capillaries. The objective of this study is to observe the changes in the eye, the nailbed microcirculation and the symptoms of patients during and after a newly identified optic nerve bleeding. We will include patients with primary open angle glaucoma with new optic nerve bleeding that attend the glaucoma clinics at Moorfields eye hospital. During a year the participants will attend 5 visits to identify changes in the optic nerve bleeding, the microcirculation of the eye and nailbed, the visual field, the quality of life and the symptoms related to abnormal circulation. This information will help us better understand the impact that these small bleeding have in patients with glaucoma and how they are related with progression of glaucoma Consultant: Mr David Garway-Heath Recruitment End Date: 06/05/2019 Glaucoma Research at Moorfields Page 3 of 6

4 GART1049 Analysis of inner layer macular structure - function relationship with optical coherence tomography and fundus perimetry in glaucoma Currently, increasing quality of eye imaging with Spectral Domain Optical Coherence Tomography (SD-OCT) has allowed a precise quantification of the neural tissue of the inner retina, the part of the retina mainly affected by glaucoma. This has been exploited in the management of glaucoma patients, but a comprehensive way to relate anatomical changes and measurements of vision (such as Visual Field Testing) is still lacking. In this study, a novel method for the integration of anatomical and vision changes for the central retina (macula) will be developed, specifically analysing possible sources of mismatch between the two measurements. Visual field testing with eye tracking technology (Fundus perimetry) and SD-OCT will be used for functional and structural assessment respectively. A model to relate structure and function in healthy subjects, also accounting for the axial length of the eye (as a surrogate of the eye size) and the age of the subject, will be developed and used to analyse changes in eyes affected by macular damage from glaucoma. Consultant: Mr David Garway-Heath Recruitment End Date: 11/12/2018 GART1050 Systemic Mitochondrial Function: A Clinically Useful Novel Biomarker For Open Angle Glaucoma Glaucoma is a neurodegenerative disease of the optic nerve and the leading cause of irreversible blindness worldwide. Raised eye pressure is the major risk factor for glaucoma, but patients deteriorate at all levels of eye pressure, suggesting that the pathogenesis of glaucoma is multifactorial. The second most important established risk factor for glaucoma is increasing age. A useful biological marker of ageing is mitochondrial function. Mitochondria, the so called 'powerhouses' of the cell, are structures within every cell that produce energy and are therefore fundamental to cell life and death. Glaucoma is characterised by the selective and gradual loss of specific cells in the optic nerve called retinal ganglion cells (RGCs), which are highly energy dependent, and increasing evidence suggests that systemic mitochondrial abnormalities are implicated in glaucoma. We have recently concluded a novel exploratory study showing, for the first time, that patients who do not develop glaucoma despite having a raised eye pressure have more efficient mitochondria (measured in peripheral blood lymphocytes), when compared to age-similar controls and fast progressing glaucoma patients. This would suggest that mitochondrial efficiency is associated with enhanced ability to withstand optic nerve damage. We now propose to conduct the first, to our knowledge, observational study undertaken to investigate the association between systemic mitochondrial function and the rate of glaucoma progression in a large cohort of glaucoma patients. 200 participants from the glaucoma clinics at Moorfields Eye Hospital will be invited to participate by offering a blood sample for the analysis of systemic mitochondrial function and future genetic analyses. This observational study aims to identify the extent to which mitochondrial function explains the rate of glaucoma progression. This will enable us to determine whether mitochondrial function measured in peripheral blood can serve as a clinically useful biomarker for glaucoma susceptibility. Mitochondrial function would thus play an important role in glaucoma risk stratification; susceptible patients would be monitored more closely and treated more intensively, thus helping to prevent glaucoma blindness. Consultant: Mr David Garway-Heath Recruitment End Date: 14/01/2019 Glaucoma Research at Moorfields Page 4 of 6

5 GART1052 Validation of a POEM (patient reported outcome and experience measure) A short questionnaire, the glaucoma patient reported outcome and experience measure (POEM) was developed as part of a patient engagement exercise in The questionnaire requires further validation before it can be used in clinical practice. This study aims to validate the POEM against both clinical measures (Visual acuity and field of vision deficits) and existing, longer questionnaire tools. It also aims to optimise its psychometric properties in order to ensure that it works reliably. The intention of the glaucoma POEM is to measure two domains. The patient s perception of their experience of health care (the humanity of that care), and the patient s perception of their health related quality of life. The glaucoma POEM has been developed in a series of focus groups with patients. It has then been scrutinised by physicians to comment on the wording and language and to assess the content and the importance of the concepts tested. It was then reviewed again in focus groups by patients to get further feedback on the content, design and to reduce the risk of ambiguity in the phrasing of the questions. The current questionnaire consists of 8 questions. In this study subjects will be asked to fill in a series of questions which includes the POEM and several other commonly used questionnaires. Information will also be collected on the subject's visual acuity, visual field, age, gender and diagnosis. The subjects will be identified in glaucoma clinics in eye departments in England and will be offered the chance to complete the questionnaires either on paper or online by their clinician. Consultant: Mr David Garway-Heath Recruitment End Date: 01/01/2019 GAZG1006 THE HYDRUS MICROSTENT FOR REFRACTORY OPEN ANGLE GLAUCOMA: A PROSPECTIVE, MULTICENTER CLINICAL TRIAL (HYDRUS VII STUDY) The objective of this study is to determine if the Hydrus Microstent can reduce intraocular pressure (IOP) in patients with refractory Open Angle Glaucoma (OAG). Study subjects will have documented elevated IOP of at least 20 mmhg in the study eye that has previously failed glaucoma surgery and with uncontrolled IOP on medical therapy or is on maximal tolerable medical therapy (MTMT). The study eye may be either phakic or pseudophakic. The addition of the Hydrus is expected to lower IOP, with the same or fewer glaucoma medications, with the potential to reduce the risk of progression. Subjects will attend a screening and baseline visit. Following surgery, they will return at 1 day, 1 week, 1, 2,3,6 and 12 months. A reduction of 20% or greater in IOP is considered to be clinically meaningful; thus the study will determine the percentage of subjects achieving this level of IOP reduction with the same or fewer medications as documented at the 12-month visit when compared to baseline. Consultant: Mr Gus Gazzard Recruitment End Date: 31/08/2018 Glaucoma Research at Moorfields Page 5 of 6

6 JAYH1001 Investigation into the Effect of Previous Cataract Surgery upon Aqueous Humour Cytokine Expression and Surgical Outcome in Trabeculectomy for Uveitic Glaucoma The surgical management of glaucoma associated with inflammation in the eye is a clinical challenge. This group of patients has a greater risk of surgery being less successful over time in comparison to patients with other types of glaucoma. In addition, patients who have undergone previous cataract surgery are at further risk of glaucoma surgery being less successful. Research to date has suggested that this additional risk may be due to inflammatory factors found within the clear fluid in the front of the eye in patients who have undergone prior cataract surgery. However to date, it is not known which precise factors are involved, and identification of these may help tailor our pre-operative treatment of patients with glaucoma related to inflammation and therefore help to improve the outcomes of surgery in this challenging patient group. This pilot study aims to evaluate the levels of over sixty different inflammatory factors within the clear fluid at the front of the eye obtained from patients with glaucoma due to inflammation, who are due to undergo glaucoma surgery. Careful comparison of two groups of patients one group who have undergone prior cataract surgery, and another, who have not, will enable the identification of specific factors that differ between the two groups. Monitoring of the success of their glaucoma surgery over the first post-operative year will enable a comparison of the success rates between these two patient groups and help to identify factors that may serve as potential markers of less successful surgery. The findings of this study will provide help in developing approaches aimed at improving the rates of successful glaucoma surgery in patients with glaucoma related to inflammation in the eye. Consultant: Dr Hari Jayaram Recruitment End Date: 01/02/2019 MATR1001 Role of avastin and 5-fluorouracil in trabeculectomy surgery (RAFTS) Some patients who undergo trabeculectomy get aggressive scarring responses post-operatively and require additional subconjunctival injection of antifibrotic agents, such as 5-Fluorouracil (5-FU) to reduce scar formation and reduce the likelihood of surgical failure. There is concern that these agents are potentially toxic and may result in side effects such as keratopathy (loss of corneal epithelium) and are also painful for the patient. Vascular endothelial growth factor (VEGF) has been found to play a pivotal role in ocular wound healing. This pilot study will look at the effect of serial injections of bevacizumab (an anti-vegf agent) on modifying the wound healing response in patients showing early signs of future failure, compared to 5-FU. The purpose of the pilot is to also gather outcome data and information relating to safety and recruitment with a view to powering a definitive study addressing this issue. Consultant: Rashmi Mathew, Jonathan Clarke, Keith Barton Recruitment End Date: TBC Glaucoma Research at Moorfields Page 6 of 6

AMD research at Moorfields

Recruiting Research Studies AMD research at Moorfields Moorfields Eye Hospital wants to improve access to clinical research studies for all patients within the NHS and provide the opportunities for patients