AMD research at Moorfields

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1 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 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: 14th September 2018 Ratified: 14th September 2018

DACL1011 Production of ipsc derived RPE Cells for transplantation in AMD In degenerative diseases, such as Age Related Macular Degeneration (AMD), cells are lost in the disease and cannot be

2 DACL1011 Production of ipsc derived RPE Cells for transplantation in AMD In degenerative diseases, such as Age Related Macular Degeneration (AMD), cells are lost in the disease and cannot be regenerated. Your condition is a form of Age-Related Macular Degeneration. Recently, it has been discovered that cells from the adult body, for example skin cells can be manipulated and, under the right conditions, have the ability to become any cell in the body including cells of the eye. Consultant: Mr Lyndon Da Cruz Recruitment End Date: 04/08/2018 PATP1022 Advanced OCT and Adaptive Optics Imaging in Retinal Disease (the ACAD study) The purpose of this study is to compare 4 different types of eye scanning machines in assessing the vitreous, retina and choroid (the layers at the back of the eye). Your doctor currently uses 3 of these scanners (2 type of SDOCT and one SSOCT scanner) routinely for patients and the fourth system (the AOSLO) is used in selected patients to assess the number of light sensitive cells and other structures in the retina. Consultant: Mr Praveen Patel Recruitment End Date: TBC AMD Research at Moorfields Page 2 of 6

3 HAMR1015 A Phase III Randomised, Double-masked, Parallel Group, Multicentre Study to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity between SB11 (proposed ranibizumab biosimilar) and Lucentis in Subjects with Neovascular Age-related Macular Degeneration Age-related macular degeneration (AMD) is a common eye condition and a cause of vision loss among people aged 50 and older. It is characterised by damage to the macula - part of the eye needed for sharp, central vision. In neovascular (wet) AMD, blood vessels grow, these can leak fluid and blood causing central vision to be blurred, decreased or even lost. AMD, left untreated, is a leading cause of adult blindness. In this study we will evaluate if a new treatment, SB11, is as effective and safe as ranibizumab (Lucentis ) at treating neovascular AMD. Lucentis is already approved to treat neovascular AMD. SB11 is a biological medicine that is similar to Lucentis. Lucentis and SB11 contain an antibody that sticks to VEGF-A, this prevents VEGF-A interacting with receptors on the surface of endothelial cells (cells that line blood vessels). This stops VEGF-A causing an increase in cell numbers, new blood vessels forming and leakage from blood vessels all of which contribute to neovascular AMD worsening. Patients recruited into the study will be aged 50 or over with newly diagnosed, active subfoveal Choroidal Neovascularisation lesion (growth of new blood vessels that originate from the choroid underneath the retina) secondary to AMD. This is a double-masked study, neither the patient nor the doctor will know if the patient is receiving SB11 or Lucentis. Patients will be randomised (assigned by chance similar to flipping a coin) and have an equal chance of receiving SB11 or Lucentis. If eligible for the study patients will enter the treatment period; patients will be administered SB11 or Lucentis via an injection into the eye every 4 weeks up to a total of 13 administrations. After the treatment period patients will attend an End of Study visit. In total there are 16 visits at the study centre. Consultant: Mr Robin Hamilton Recruitment End Date: TBC AMD Research at Moorfields Page 3 of 6

4 SIVS1017 Structure Function Correlation in aging and age related macular degeneration (Fuchsia Study) This study is an observational study, aiming to increase the understanding of the natural history of AMD and evaluate the characteristics and possible eye problems before the onset of advanced AMD in people with early AMD, or family members of people with AMD and any willing person above the age of 55 years who have no known eye conditions who are keen to have these tests done and the eyes monitored during the study. Participants will be seen annually at 12, 24, 36, months and data will be collected at each visit. This will include and eye examination, multiple visual function tests, images of the back of the eye and a sputum sample to study genetics and the DNA will be stored for future research in this condition. Consultant: Ms Sobha Sivaprasad Recruitment End Date: 01/08/2020 SIVS1025 An exploratory study to evaluate the effect of 670nm LED light exposure on retinal function and morphology in healthy elderly subjects and patients with early age related macular degeneration Photoreceptors (cells which convert light to an electric signal) in the retina (the sensory layer in the back of the eye)demand more energy than other tissue in the body. Unfortunately, as we grow older, the energy producing units in our cells (mitochondria) become less efficient and produce less energy. This is associated with inflammation (the body s response to an insult) which we think contributes to age-related macular degeneration (AMD) and aging in general. AMD is the commonest cause of blindness in the elderly and unfortunately, there is no prevention or cure for this. A molecule in mitochondria can absorb a particular wavelength of light (670nm which is red) and increase energy production. This has been shown in different cells, including the retina. Studies have also shown that inflammation associated with aging and AMD is reduced by exposure to this red light. This is a pilot study to see if exposure to 670nm wavelength of light can improve visual function in aging and age related macular degeneration. Participants will hold a device emitting this red light to their eyes for one minute every day for one year and have their retinal function measured before and after. Consultant: Ms Sobha Sivaprasad Recruitment End Date: 01/10/2018 AMD Research at Moorfields Page 4 of 6

5 SIVS1039 A dose-ranging study of intravitreal OPT-302 in combination with ranibizumab, compared with ranibizumab alone, in participants with neovascular age-related macular degeneration (wet AMD) The purpose of this research study is to determine whether adding an additional injection of an investigational drug, OPT-302, after an injection of the approved anti-vegf drug ranibizumab, is safe and effective in the treatment of wet- AMD. This new combination therapy will be compared to the standard treatment of ranibizumab administered alone. Consultant: Ms Sobha Sivaprasad Recruitment End Date: 30/11/2018 SIVS1040 The Monarch Study Wet age-related macular degeneration (AMD) is the commonest cause of blindness in the UK. Providing promptaccess to clinics for regular surveillance and treatment has proved a major challenge for the NHS. Most patients needa series of injections followed by a period of regular check-ups in case more injections are required. Wet AMD can often flare up after a period when treatment has not been required and check-ups are usually needed for several years. Vision tests completed by patients themselves at home (we call these "home monitoring" tests) to detect the need for treatment could mean that patients would not need regular hospital check-ups, allowing clinic appointments to be kept for patients likely to require treatment. Home monitoring would be more convenient and less costly for both the patient and the NHS. The main aim of our study is to find out whether our chosen home monitoring tests can detect when wet AMD needs to be treated as well as the tests currently carried out at hospital check-ups. We will evaluate three home monitoring tests; a paper booklet and two vision test software applications (MultiBit test and MyVisionTrack ) that run on an ipod touch. We will recruit approximately 400 participants from 5 hospitals who will be asked to perform the home monitoring tests weekly for both eyes at home in between their standard hospital checkups over a period of 1-2 years. All equipment will be provided and every other aspect of care will stay the same. The home monitoring test results will not be known by patient's hospital care teams. We are also investigating the acceptability of home monitoring to both participants and their carers at 3 of the 5 hospitals. We will interview a sample of participants and carers in their homes and by telephone or Skype. Consultant: Ms Sobha Sivaprasad Recruitment End Date: 01/03/2020 AMD Research at Moorfields Page 5 of 6

6 SIVS1044 A Randomized, Double Masked, Uncontrolled, Multicenter Phase I/II Study to Evaluate Safety and Tolerability of PAN Eye Drops, Suspension in Treatment-Naïve Participants with Neovascular Age-Related Macular Degeneration (AMD) The eye condition called neovascular age-related macular degeneration (AMD) is the most common cause of irreversible vision loss in people aged 50 years or older. Several therapies, administered through intravitreal injections, are already approved for the condition. This study is a double-masked, multi-center study to evaluate the safety, tolerability, and biological response of PAN Eye Drops in treatment-naïve patients with active, choroidal neovascularisation (CNV), which is the abnormal growth of blood vessels in the eye associated with AMD. The primary objectives of this study are to assess the safety and tolerability of PAN Eye-Drops, and secondarily to assess any biological responses to treatment in approximately 60 adults. Biological response will be assessed by changes in vision, changes to the center of the retina, and need for rescue therapy. Adults, aged 50 years or older, of any race and either sex with an eye newly diagnosed with CNV lesions secondary to neovascular AMD will be screened for inclusion into the study after providing written informed consent. Participants who are eligible for the study will be randomized (1:1:1) at Day 1 to one of three doses of PAN Eye Drops administered once daily for 12 weeks: 2 mg/ml, 6 mg/ ml, or 10 mg/ml. The study is masked, which means that neither the participant nor the study doctor will know to which dose the participant has been assigned. During the treatment period, participants will return for follow-up visits at Week 2, Week 4, Week 8, and Week 12. Then they will return for visits 1 week and 1 month after completion of treatment. Telephone contacts will be performed at Week 6 and Week 10 to assess participant s well-being. Participants meeting the study s criteria of worsening AMD, will be eligible for rescue therapy with ranibizumab, one of the approved drugs for AMD. Consultant: Ms Sobha Sivaprasad Recruitment End Date: 01/04/2019 AMD Research at Moorfields Page 6 of 6

Ophthamology Directorate. Eye Injection for Macular Disorders Information for Patients

Ophthamology Directorate. Eye Injection for Macular Disorders Information for Patients Ophthamology Directorate Eye Injection for Macular Disorders Information for Patients As discussed at your appointment today, please call the Medical Retinal Services Coordinator as soon as possible (within