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Cecilia Morton
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Performance in Initiating and Delivering Clinical Research As a

priority to offer as many patients as possible the opportunity to

Moorfields delivers cutting edge treatments and has a diverse

into trials with wide ranging eye care needs.

co-ordinators and research managers that support this ambition.

Ophthalmology partnership p is a major priority, but we also strive

trials as thiss both broadens the research portfolio and increases

researchh and clinical trial delivery performance and look

recruitment performance and time to target metrics.

research studies running and open 40 clinical trials in progress

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 patients 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 patients 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 p is a major priority, but we also strive to attract more and more global partnerships for delivering clinical trials as thiss 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 researchh and clinical trial delivery performance and look continuously for ways to speedd up set up times, improve our patient recruitment performance and time to target metrics. Currently we have: 1384 patients enrolled in clinical trials 246 research studies running and open 40 clinical trials in progress from Phase 1 to Phase 4 28 other clinical trials in progress Contacts Julian. Hughes@moorfields.nhs.uk Anna.Jones@moorfields.nhs.uk Version: Status: Approved: Ratified: 1 RELEASEE 28/10/ /10/2014

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

3 Table 1: Performance in Initiating Clinical Research 1 st Oct th Sep 2014 This table summarises Moorfields Eye Hospital s performancee in initiating clinical trials by recruiting the first patient to the trial within 70 days of receivingg 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 thee final column. Name of Trial SVOP: A new visual field test for children: an exploratory study to evaluate saccadic vector optokinetic perimetry in children with visual and neurological disabilities Research Ethics Committee Reference Number 13/ /LO/0859 Date of Receipt of Valid Researchh Applicatio n 09/10/2013 Date of NHS Permissio n 11/10/ /2013 Date of First Patient Recruited 22/ /10/2013 Benchm ark Met es Reason if the study did not meet the benchmark RAPID: Assessing the effectiveness of imaging technology to rapidly detect disease progression in glaucoma 13/ /NS/ /11/ /12/ / / /12/2013 es The Role of Glassess Wearing in Amblyopia Treatment Version 1 Evaluation of Clinical Outcomes Following Treatment with Systane Balance in Dry Eye Subjects with Lipid Deficiency 13/ /EM/ / /EE/ /11/ /12/ / / /01/ /02/ /02/ / / /03/2014 es es A phase III, Multi Multi National, center, Randomized, Masked, Controlled, Safety and Efficacy Study Of A Fluocinolone Acetonide Intravireal (FAI) Insert In Subjects With Chronic n Uveitis Infectious Affecting The Posterior Segment Of The Eye 13/ /LO/ /03/ /03/ / / /04/2014 es 2

4 BP28936 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. A prospective trial of simultaneous transepithelial photorefractive keratectomy and corneal collagen cross linking for keratoconus 13/ /NE/ / /SC/ /02/ /02/ / / /03/ /06/ /06/ / / /08/2014 es es An assessment of the the RAPDx pupillometer investigating test retest reliability, and strength of associations between relativee afferent pupil defect magnitude and measures of structure and function in patients with different subtypes of glaucoma and other optic neuropathies 14/ /EM/ /06/ /06/ / / /07/2014 es 3

5 A 12 month, phase IIIb, 14/ /EM/0001 randomised, visual acuity assessor masked, multicentre study assessing the and safety of ranibizumab 0.5mg in treat and extend regimen (TER) compared to monthly regimen in patients with neovascular age related macular degeneration (TREND) ECLIPSE: Fovista and 13/ /LO/1686 Lucentis compared to Lucentis alone in patients with AMD CLEOPATRA (Lightmask) 13/ /LO/ /03/ /04/ / / /05/ /05/ /05/ / / /07/ /02/ /04/ / / /04/2014 es es es A randomized, double masked, placebo and controlled, safety study of RV 001, an insulin like growth factor 1 receptor (IGF (fully human), administered every 3 1R) antagonist antibody weeks (q3w) by intravenous (iv) infusion in patients suffering from active thyroid eye diseasee (TED) Clinical evaluation of the AqueSys XEN implant in mild to moderate open angle glaucoma subjects 14/ /LO/ / /EE/ /07/ /07/ / / /08/ /06/ /07/ / / /08/2014 es es Post market clinical follow uthe marketed Extended Range of Vision IOL investigation of 14/ /LO/ /06/ /07/ / / /08/2014 es 4

6 Clinical Efficacy and Mechanistic Evaluation of Aflibercept for Proliferative Diabetic Retinopathy (acronym CLARIT). A Multicentre Phase IIb Randomised Active Controlletrial Clinical Tangent vs bowl perimetry: an exploratory study 14/ /LO/ / /SC/ /07/ /08/ / / /08/ /08/ /09/ /2014 N/ /A es Within 70 days BOL X 0.024% (Latanoprostene Bunoda) ophthalmic solution vs. Timolol Maleate ophthalmic solution 0.5% (Safety and study in adults) (LUNAR) Stem cell transplantation in wet AMD 13/ /NS/0065 GTAC194 17/10/ /12/ / / /04/ /06/ /11/ /2013 N/ /A Permissions delayed Patients Consented Sponsor delays PROMETHEUS: A 12 month, randomized, double masked, multicenter study to evaluate the and safety of 0.5 mg ranibizumab intravitreal injections in patients with visual impairment due to vascular endothelial growth factor (VEGF) driven macular edema (ME) Eyeguard B A double Diseasee masked, placebo controlled study in patients with Behcet s Uveitis 13/ /EM/ / /LO/ /12/ /12/ / / /04/ /09/ /10/ / / /02/2014 Rare Diseasee Rare Diseasee A Phase III multicentre randomised double blind placebo controlled study to assess the and safety of Tocilizumab in patients with Giant Cell Arteritis 13/ /LO/ /11/ /11/ /2013 N/ /A Rare Diseasee 5

7 n contact screening methods for the detection of narrow anterior chamber angles Recognition perimetry using high pass filtered letter targets in normal subjects and patients with glaucoma Monoprost compared with Lumigan in POA glaucoma/ocular hypertension Exploratory Study of a binocular therapy for strabismic and mixed amblyopia: home based "BBV treatment" for children 13/ /LO/ / /LO/ / /EM/ / /LO/ /02/ /02/ /04/ /04/ /02/ / /04/ / /04/ / /05/ / / /04/ / /05/2014 N/ /A 25/ /06/2014 patients seen Out of hours clinic resourcee Permissions delayed patients seen patients consented Randomized trial of wide diabetic macular oedema (DMO) treated with Ranibizumab. (Ranibizumab for DMO field guided PRP for PRP trial (RDP trial) )) Eyeguard A A double masked, placebo controlled study in patients with active NIU 13/ /NE/ / /LO/ /05/ /06/ /2014 N/ /A 20/06/ /08/ /2014 N/ /A patients seen Sponsor delays patients seen Eyeguard C A double masked, placebo controlled study in patients with controlled NIU 13/ /LO/ /06/ /08/ /2014 N/ /A Rare disease Sponsor delays patients seen Rare disease 6

8 Table 2: Performance in Delivering Clinical Research 1 st Oct th Sep 2014 This table summarises Moorfields Eye Hospital s performancee in delivering clinical trials in line with the recruitment targets specified by thee trials sponsor. The data illustrates whether the agreed number of patients were recruited by the site by the specified recruitmentt end date. Name of Trial Research Ethics Committee Reference Number Target number of patients Date Agreed to recruit target number of patients Trial Status Target met within the agreed time (and( reason if i ) LUMINOUS: Study to observe the effectiveness and safety of LUCENTIS throughh individualised patient treatment and associated outcomes 11/H/0140 A multi centre open label study of the long term safety and of the human anti TNF monoclonal antibody Adalimumab in subjects with non or pan uveitis 10/H0406/47 A Phase I/II, open label, multi centre, prospective study to determinee the infectious intermediate, posterior, safety and tolerability of sub retinal transplantation of human Embryonic Stem Cell derived Retinal Pigmented Epithelial (hesc RPE) cells in patients with Stargardt?s Macular GTAC181 An open label study to evaluatee 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/ /06/ /10/ /04/2015 Closed 5 15/01/2014 Complete Trial Still Trial still open A 3 year, multi centre study to evaluate optical coherence tomography as an outcome measure in patients with multiple sclerosis 12/LO/ /06/2014 7

9 A 24 month, phase IIIb, open label, randomised, active controlled, 3 arm, multicentre study assessing the and safety of an individualised, stabilisation criteria driven PRN dosing regime with 0.5mg ranibizumab intravitreal injections applied 12/SC/0025 A 24 month, phase IIIb, open label, single arm, multicentre study assessing the and safety of an individualised, stabilisation criteria driven PRN dosing regime with 0.5mg ranibizumab intravitreal injections applied as monotherapy in patient 12/SC/ /06/ /02/2013 A 12 Month, Multicentre, randomised parallel group study to compare the and safety of Ozurdex vs Lucentis in patients with Branch Vein Occlusion (BRVO) (COMO study) 11/LO/1023 REPARO NGF0212 Phase I/II Neurotrophic Keratitis Trial 13/LO/0049 Closed 10 15/11/2013 Complete 4 31/12/2014 Trial Still A 3 month multicenter double study of masked safety and Travoprost Ophthalmic solution, 0.004% to Timolol (0.5% or 0.25%) in paediatric glaucoma patients 13/EM/ /05/2013 OCTAVE, Ranibizumab in neovascular age related macular degeneration 13/LO/0520 CONSTANCE Ozurdex PASS 12/H/0231 Argus II Retinal Stimulation System Feasibility Study 07/H0721/ year use of Aflibercept study for treatment of wet AMD 13/EE/0274 Distance of Choroid DOCS 13/LO/0951 Eyeguard B A double masked, placebo controlled study in patients with Behcet s Disease Uveitis 12/LO/ /04/ /03/ /04/ /05/2014 Closed 40 31/07/2014 Complete 1 15/11/2014 Trial Still 8

10 BOL X 0.024% (Latanoprostene Bunoda) ophthalmic solution vs. Timololl Maleate ophthalmic solution 0.5% (Safety and study in adults) (LUNAR) 13/NS/0065 A multicentre study of the and safety of the human anti TNF monoclonal antibody Adalimumab as maintenance therapy in subjects with inactive non infectious intermediate, posterior or pan uveitis 10/H0406/46 Post market clinical follow up investigation of the marketed Extended Range of Vision IOL A multicentre study of the and safety of the human anti TNF monoclonal antibody Adalimumab as maintenance therapy in subjects requiring high dose corticosteroids for active non infectiou us intermediate, posterior, or pan uveitis A randomized, double masked, placebo controlled, and safety study of RV 001, an insulin like growth factor 1 receptor (IGF 1R) antagonist antibody (fully human), administered every 3 weeks (q3w) by intravenous (iv) infusion in patients suffering from active thyroid eye diseasee (TED) A 12 month, phase IIIb, randomised, visual acuity assessor masked, multicentre study assessing the and safety of ranibizumab 0.5mg in treat and extend regimen (TER) compared to monthly regimen in patients with neovascular age related macular degeneration (TREND) A multicentre, double masked, randomised, active controlled, parallel study of the safety and of once daily Bimatoprost preservative free ophthalmic solution compared to twice daily solution in paediatric patients with glaucoma Timolo ophthalmic 14/LO/ /H0406/45 14/LO/ /EM/ /LO/ /04/ /10/ /09/2014 Closed 4 30/09/2014 Complete 2 01/07/ /10/ /10/2015 Trial Still Trial Still 9

11 Follow up study for patients with Retinal Cells Derived from Stem Cells for Stardgart's Macular Dystrophy GTAC198 A randomised, active controlled, open label, multiple dose, proof of concept study of intravitreal LFG316 in patients with MFC 12/SW/0084 Fingolimod in optic neuritis (ADON) 13/LO/0524 Multicentre, international, transveral and epidemiological survey to determine the characteristics and satisfaction of tolerance of glaucoma. Goal survey Glaucoma patients treated with prostaglandins Satisfaction evaluation 13/LO/0283 Stem cell transplantation in wet AMD GTAC194 Efficacy and Safety assessment of T4020 versus vehicle in patients with chronicc neurotrophic keratitis or corneal ulcer. Phase III study, international, multicentre, randomised, doublemasked, 2 parallel groups, versus vehicle, in 124 evaluable patients treated for 28 days. HARMONISAT TION 13/ /H/0086 A Phase III multicentre randomised double blind placebo controlled study to assess the and safety of Tocilizumab in patients with Giant Cell Arteritis 13/LO/ /01/ /04/2014 Suspended 4 30/06/2015 Withdrawn /12/ /01/ /12/ /06/2015 N/A Trial suspendeds N/A Trial withdrawn A prospective, two centre randomised controlled exploratory study of the PresView Scleral Implant (PSI) for the treatment of ocular hypertension and primary open angle glaucoma A phase III, Multi National, Multi center, Randomized, Masked, Controlled, Safety and Efficacy Study Of A Fluocinolone Acetonide Intravireal (FAI) Insert In Subjects With Chronic n Infectious Uveitis Affecting The Posterior Segment Of The Eye 12/SW/ /LO/ /02/2016 Withdrawn 5 31/12/2014 N/A Trial withdrawn 10

12 INJECT: Investigation of Jetrea in patients with confirmed Vitreomacular Traction 13/LO/1737 ECLIPSE: Fovista and Lucentis compared to Lucentis alone in patients with AMD 13/LO/1686 Monoprost compared with Lumigan in POA glaucoma/ocular hypertension 13/EM/0348 BP28936 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/ /05/ /12/ /12/ /12/2014 A : Long Term Surveillance study of Latanoprost to monitor hyperpigmentationn changes in the eye in paediatric populations 14/LO/0654 MEMO: Patient questionnaire study 14/WS/0092 Eyeguard C A double masked, placebo controlled study in patients with controlled NIU 13/LO/0717 Eyeguard A A double masked, placebo controlled study in patients with active NIU 13/LO/ /07/ /05/ /03/ /06/2015 Clinical evaluation of the AqueSys XEN implant in mild to moderate open angle glaucoma subjects A Phase III, Multinational, Multicenter, Randomized, Double and Efficacy of Intravitreal Injections of DE 109 (three doses) for the Masked, Study Assessing the Safety Treatment of active, n Infectious Uveitis of the Posterior Segment of the eyee 14/EE/ /LO/ /06/ /02/2014 N 11

13 A A Prospective, ninterventional, longitudinall cohort study to evaluate the long Treatment in Paediatric Populations 10/H0721/1 A randomised, double blind, parallel group, placebo controlled study to term safety of Xalatan (Latanoprost) assess the, safety, tolerability, and pharmacokinetics of BIIB033 in subjects with first episode of acute optic neuritis 12/SC/0527 PROMETHEUS: A 12 month, randomized, double masked, multicenter study to evaluate the and safety of 0.5 mg ranibizumab intravitreal injections in patients with visual impairment due to vascular endothelial growth factor (VEGF) driven macular edema ( ME) 13/EM/ /07/ /10/ /08/2014 N N N Evaluation of Clinical Outcomes Following Treatment with Systane Balance in Dry Eye Subjects with Lipid Deficiency 13/EE/ /12/2014 N 12

Performance in Initiating and Delivering Clinical Research

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