Performance in Initiating and Delivering Clinical Research

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Alberta Smith
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Performance in Initiating and Delivering Clinical Research As a global leading centre for research in Eyes and Vision, it is a key priority to offer as many as possible the opportunity to get

We have a dedicated research support team of nurses, trial co-ordinators and research managers that support this ambition.

1 Performance in Initiating and Delivering Clinical Research As a global leading centre for research in Eyes and Vision, it is a key priority to offer as many as possible the opportunity to get involved in Clinical Research. Moorfields delivers cutting edge treatments and has a diverse patient population that creates the opportunity to recruit into trials with wide ranging eye care needs. We have a dedicated research support team of nurses, trial co-ordinators and research managers that support this ambition. Delivering research across the Moorfields / UCL Institute of Ophthalmology partnership is a major priority, but we also strive to attract more and more global partnerships for delivering clinical trials as this both broadens the research portfolio and increases the interaction with industry to positively contribute to the UK Life Science economy. In order to speed up research translation we have a strong focus on research and clinical trial delivery performance and look continuously for ways to speed up set up times, improve our patient recruitment performance and time to target metrics. Currently we have: 267 research studies running and open 43 clinical trials in progress from Phase 1 to Phase 4 21 other clinical trials in progress Contacts Julian.Hughes@moorfields.nhs.uk Anna.Jones@moorfields.nhs.uk Gisela.baretto@moorfields.nhs.uk Version: 1 Status: RELEASE Approved: 29/07/2015 Ratified: 29/07/2015

2 Contents Section/Chapter Page Table 1: Performance in Initiating Clinical Research 2 Table 2: Performance in Delivering Clinical Research 7 1

3 Table 1: Performance in Initiating Clinical Research 1 st July th Jun 2015 This table summarises Moorfields Eye Hospital s performance in initiating clinical trials by recruiting the first patient to the trial within 70 days of receiving a valid application for NHS permissions. The benchmark column indicates whether this target has been met. Where it was not, further information on the reason for any delays are provided in the final column. Name of Trial Exploring the psychophysics of keratoconus using the Moorfields Acuity Chart. Research Ethics Committee Reference Number Date of Receipt of Valid Research Applicatio n Date of NHS Permissio n Date of First Patient Recruited 15/LO/ /04/ /04/ /04/2015 es FACT 14/LO/ /04/ /05/ /05/2015 es Positioning in Macular 14/LO/ /03/ /04/ /05/2015 es Hole Surgery Tangent versus bowl 13/SC/ /08/ /09/ /10/2014 es perimetry: an exploratory study (version 1.0) LEAVO 14/LO/ /11/ /12/ /12/2014 es Benchm ark Met Reason if the study did not meet the benchmark SAFARI 14/SC/ /10/ /10/ /10/2014 es Clinical Efficacy and 14/LO/ /07/ /08/ /08/2014 es Mechanistic Evaluation of Aflibercept for Proliferative Diabetic Retinopathy (acronym CLARIT). A Multicentre Phase IIb Randomised Active-Controlled Clinical trial VITAL. 14/LO/ /10/ /11/ /12/2014 es CCRN 3101 (Glaucoma) 14/EE/ /06/ /07/ /08/2014 es 2

4 Treatment of Advanced Glaucoma Study (TAGS): A multicentre randomised controlled trial comparing primary medical treatment with primary augmented trabeculectomy for people with newly diagnosed advanced glaucoma OPHT 3328 (Thyroid Eye Disease) 13/EM/ /07/ /08/ /08/2014 es 14/LO/ /07/ /07/ /09/2014 es OPHT 3304 (Extended 14/LO/ /06/ /07/ /08/2014 es range of vision IOL) Efficacy and Safety 14/LO/ /02/ /02/ /04/2015 es assessment of fixed combination unpreserved Latanoprost eye drops and Timolol 0.5% (T2347) versus Xalacom«in ocular hypertensive or glaucomatous ASCOT 14/LO/ /10/ /10/ /12/2014 es A Randomized, Doublemasked, Placebocontrolled Study of the Safety and Efficacy of Gevokizumab in the Treatment of Subjects with Non-infectious Intermediate, Posterior, or Pan-uveitis Currently Controlled with Systemic Treatment. The EEGUARDÖ-C Study Tafluprost in paediatric glaucoma/ocular hypertension 13/LO/ /06/ /08/ /11/2014 No No eligible Rare Disease Permissions Delays 14/WM/ /11/ /11/2014 No No eligible Rare Disease 3

5 CCRN 2159 (Uveitis) 13/LO/ /06/ /08/2014 No No eligible Rare Disease Permissions Delays A phase III, multicenter, randomised, doublemasked, sham-controlled study to assess the efficacy and safety of Lampalizumab administered intravitreally to with GA secondary to AMD 14/SC/ /03/ /04/ /06/2015 No No eligible Table 2: Performance in Delivering Clinical Research 1 st July th Jun 2015 This table summarises Moorfields Eye Hospital s performance in delivering clinical trials in line with the recruitment targets specified by the trials sponsor. The data illustrates whether the agreed number of were recruited by the site by the specified recruitment end date. Name of Trial Argus II Retinal Stimulation System Feasibility Study Research Ethics Committee Reference Number Target number of Date Agreed to recruit target number of Trial Status 07/H0721/ /04/2012 Closed - in Target met within the agreed time (and reason if No) A multicentre study of the efficacy and safety of the human anti-tnf monoclonal antibody Adalimumab as maintenance therapy in subjects requiring high dose corticosteroids for active non-infectious intermediate-, posterior-, or pan-uveitis 10/H0406/ /09/2014 Closed - 4

6 Prospective Clinical Trial to evaluate the clinical results of implantation of the revision optics inlay for treatment of presbyopia 10/H0721/ /12/2014 Closed - An open-label study to evaluate the effects of repeated treatments of oral QLT on safety and vision outcome in subjects with LCA or RP due to inherited deficiencies in RPE65 or LRAT. Extension study 12/LO/ /01/2014 Closed - CCRN 1049 (Behcets Disease Uveitis) 12/LO/ /04/2015 BRIGHTER (CRFB002E2402): A 24month, phase IIIb, open-label, randomized, active controlled, 3arm, multicenter study assessing the efficacy and safety of an individualized, stabilization-criteriadriven PRN dosing regimen with 0.5mg ranibizumab intravitreal injections applied as monotherapy or with adjunctive laser photocoagulation in comparison to laser photocoagulation in with visual impairment due to macular edema secondary to branch retinal vein occlusion (BRVO) CCRN 729 ASH Aflibercept: ASH - CRFB002AGB16: A prospective, observational, multi-centre, 2 year study evaluating the use of Eylea (aflibercept) for the treament of neovascular (wet) age related macular degeneration in UK NHS opthamology 12/SC/ /06/2013 Closed - in 13/EE/ /05/2014 Closed - in clinics. CCRN 2093 (Neurotrophic Keratitis) 13/LO/ /12/2014 Closed - in 5

7 CCRN 2386 (Glaucoma) 13/LO/ /12/2014 Closed - in Distance of Choroid- DOCS 13/LO/ /07/2014 Closed - CCRN 2591 (Chronic Non-infectious Uveitis) 13/LO/ /03/2015 Closed - in BP A MULTIPLE-CENTER, NON- RANDOMIZED, OPEN-LABEL, SINGLE- ASCENDING-DOSE, PARALLEL STUD TO INVESTIGATE THE SAFET, TOLERABILIT, SSTEMIC PHARMACOKINETICS AND PHARMACODNAMICS OF RO FOLLOWING INTRAVITREAL ADMINISTRATION IN PATIENTS WITH WET AGE-RELATED MACULAR DEGENERATION. 13/NE/ /12/2014 Closed - Cacicol Study 13/H/ /06/2015 Closed - in CCRN 3101 (Glaucoma) 14/EE/ /06/2015 Closed - in CCRN 2875 (Age-related macular 14/EM/ /10/2014 Closed - in degeneration) BOL X 0.024% (Latanoprostene Bunoda) ophthalmic solution vs. Timolol Maleate ophthalmic solution 0.5% (Safety and efficacy study in adults) (LUNAR) OPHT 3304 (Extended range of vision IOL) 14/ES/ /05/2014 Closed - 14/LO/ /09/2014 Closed - in OPHT 3328 (Thyroid Eye Disease) 14/LO/ /11/2015 6

8 CCRN 3104 (Intravitreal Implant) 14/NI/ /12/2015 CCRN 2997 (Macular Dystrophy) GTAC /04/2015 Closed - in A phase III, multicenter, randomised, double-masked, sham-controlled study to assess the efficacy and safety of Lampalizumab administered intravitreally to with GA secondary to AMD 14/SC/ /09/2015 N/A Trial Still Monopost vs Lumigan 13/EM/ /12/2015 N/A Trial Still A 48-week, double-blind, randomised, multi-centre, parallel-group study comparing structural changes in the retina and evolution of visual function after immediate versus delayed treatment with fingolimod in with acute demyelinating optic neuritis 13/LO/ /06/2016 Withdrawn N/A Sponsor has withdrawn trial CCRN 2159 (Uveitis) 13/LO/ /07/2016 N/A Trial Still A Randomized, Double-masked, Placebo-controlled Study of the Safety and Efficacy of Gevokizumab in the Treatment of Subjects with Noninfectious Intermediate, Posterior, or Pan-uveitis Currently Controlled with Systemic Treatment. The EEGUARDÖ-C Study 13/LO/ /11/2015 N/A Trial Still ECLIPSE: FovistaÖ and Lucentis«compared to Lucentis«alone in with AMD (Ophthotech) JETREA FIRSTLINE (ALCON) - Assessment of Anatomical and Functional Outcomes in Patients Treated with Ocriplasmin for Vitreomacular Traction/Symptomatic Vitreomacular Adhesion (VMT/sVMA) 13/LO/ /08/2015 N/A Trial Still 13/LO/ /05/2016 N/A Trial Still 7

9 A :Long Term Safety Study of Xalatan in Paediatric Populations 14/LO/ /07/2015 N/A Trial Still Efficacy and Safety assessment of fixed combination unpreserved Latanoprost eye drops and Timolol 0.5% (T2347) versus Xalacom«in ocular hypertensive or glaucomatous 14/LO/ /06/2015 N/A Trial Still SAFARI 14/SC/ /03/2016 N/A Trial Still Tafluprost in paediatric glaucoma/ocular hypertension MEMO An Observational Study on the Prevalence of Metamorphopsia and its Impact on Health Related Quality of Life in Patients Diagnosed with Vitreomacular Traction. CCRN 1015 (Age-related Macular Degeneration) Follow-up study for with Retinal Cells Derived from Stem Cells for Stardgart's Macular Dystrophy A Multicenter, Double-masked, Randomized, Active-controlled, Parallel Study of the Safety and Efficacy of Once-daily Bimatoprost Preservative-free Ophthalmic Solution Compares to Twice-daily Timolol Ophthalmic Solution in Paediatric 14/WM/ /07/2017 N/A Trial Still 14/WS/ /05/2016 N/A Trial Still GTAC /03/2016 N/A Trial Still GTAC /01/2019 N/A Trial Still 11/LO/ /10/2015 Closed - Patients With Glaucoma CCRN 2821 (Dry eye lipid deficiency) 13/EE/ /12/2014 Closed - PROMETHEUS A 12-month, randomized, double-masked, shamcontrolled, multicenter study to evaluate the efficacy and safety of 0.5mg ranibizumab intravitreal injections in with visual impairment due to vascular endothelial growth factor (VEGF) driven macular edema (PROMETHEUS: CRFB002G2302) 13/EM/ /08/2014 Closed - N Study closed prematurely by sponsor N Sponsor closed study early N Target was not met though additional has been identified when study recruitment closed 8

10 A Phase III multicentre randomised double-blind placebo controlled study to assess the efficacy and safety of Tocilizumab in with Giant Cell Arteritis 13/LO/ /06/2015 Closed - N - Sponsor closed study early 9

As a global leading. Moorfields delivers. Moorfields. economy. Version: Status: Approved: Ratified:

As a global leading. Moorfields delivers. Moorfields. economy. Version: Status: Approved: Ratified: Performance in Initiating and Delivering Clinical Research As a global leading centre for research in Eyes and Vision, it is a key priority to offer as many patients as possible the opportunity to get