Performance in Initiating and Delivering Clinical Research

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Lester Cook
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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 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: 320 research studies running and open 45 clinical trials in progress from Phase 1 to Phase 4 Contacts Julian.Hughes@moorfields.nhs.uk Geeta.Ghadiali@moorfields.nhs.uk Sabeena.Johal@moorfields.nhs.uk Tania.West@moorfields.nhs.uk 1

2 Contents Section/Chapter Page Table 1: 2 Table 2: Performance in Delivering Clinical Research 6 2

3 Table 1: 1 st January st December 2017 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 by Selecting Study Site. 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 IRAS No. Research Ethics Committee Reference Date Site Invited Date Site Selected HRA Approval Date Date Site Confirmed by Sponsor Date Site Confirmed Date Ready to Start First Recruit Date Reason if not hit benchmark Source of Delay 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 /LO/ /01/ /01/ /04/ /02/ /02/ /02/ /03/2017 3

4 An open label, multi-centre, Phase I/II dose escalation trial of a recombinant adeno-associated virus vector (AAV2/5- hrkp.rpgr) for gene therapy of adults and children with X-linked Retinitis Pigmentosa owing to defects in Retinitis Pigmentosa GTPase Regulator (RPGR) /LO/ /01/ /06/ /06/ /06/ /07/ /07/ /07/2017 4

5 Randomized, Assessor-Masked, Active-Controlled, Phase 3 Study to Evaluate Efficacy, Safety and Tolerability of 0.08% Polyhexamethylen e Biguanide (PHMB) Ophthalmic Solution in Comparison with 0.02% PHMB + 0.1% Propamidine Combination Therapy in Subjects Affected by Acanthamoeba keratitis /LO/ /02/ /06/ /06/ /07/ /07/ /08/ /08/2017 5

6 A Prospective Single-Site Non- Interventional Study to Evaluate the Diagnostic Accuracy and Repeatability of Pupil Measurements using a Prototype Binocular Optical Coherence Tomography System /LO/ /01/ /03/ /03/ /05/ /05/ /05/ /05/2017 Contact Lens Device for Continuous Monitoring of Intraocular Pressure (II-LS ) /NW/ /06/ /07/ /06/ /07/ /07/ /07/ /08/2017 PANORAMA_ VGFTe-OD /SC/ /02/ /02/ /03/ /06/ /06/ /06/ /07/2017 Contracting Delays Neither 6

7 Long-term followup study of participants following an open label, multicentre, Phase I/II dose escalation trial of a recombinant adeno-associated virus vector (AAV2/8- hcarp.hcngb3) for gene therapy of adults and children with achromatopsia owing to defects in CNGB /LO/ /03/ /04/ /04/ /05/ /05/ /06/ /06/2017 A Prospective, Randomized, Controlled, Multi- Center Clinical Study of the ACRYSOF IQ Extended Depth of Focus (EDF) IOL /EE/026 31/01/ /05/ /06/ /08/ /07/ /07/ /11/2017 Sponsor Delays Sponsor Delays Sponsor Sponsor 7

8 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 /LO/ /03/ /07/ /06/ /09/ /08/ /09/2017 A Phase 2, Randomized, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Filgotinib in Subjects with Active Non- Infectious Uveitis /LO/ /08/ /09/ /08/ /09/ /10/ /10/2017 Sponsor Delays / Permissions Delayed No Patients Consented Sponsor Neither 8

9 Table 2: Performance in Delivering Clinical Research 1 st January st December 2017 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 patients were recruited by the site by the specified recruitment end date. Name of Trial Research Ethics Committee Reference IRAS No. Target number of patients agreed Min Target no. of patients Max Target number of patients If Agreed, Date Agreed to recruit target number of patients Numb er of patien ts recrui ted by target date The total number of study participants recruited Date trial closed to recruitment Reason Trial Closed to Recruitment GX /NE/ A Randomized DoubleMasked ShamControlled Pivotal Clinical Trial to Evaluate the Efficacy of a Single Intravitreal Injection of GS raavnd in Patients Affected for to Months by Leber Hereditary Optic Neuropathy Due to the GA Mutation in the Mitochond 15/LO/ Agreed /03/ /01/2017 Recruitment Finished Agreed /12/ /03/2017 Recruitment Finished

10 Managing neovascular agerelated macular degeneration (namd) over 2 years with a Treat and Extend (T&E) regimen of 2 mg intravitreal aflibercept - a randomized, open-label, active-controlled, parallel-group phase IV/IIIb study (ARIES) 16/LO/ Natural History of the Progression of Choroideremia Study. 15/WM/ A PHASE II, MULTICENTER, RANDOMIZED, DOUBLE- MASKED, 4 PARALLEL ARMS, CONTROLLED 6-MONTH TRIAL DESIGNED TO EVALUATE THE SAFETY AND EFFICACY OF PAD CICLOSPORIN (CSA 0.06% AND 0.03%) OPHTHALMIC DISPERSION ADMINISTERED ONCE DAILY IN COMBINATION WITH LUBR 15/LO/ Agreed /03/ /05/2017 Recruitment Finished Agreed /04/ /04/2017 Recruitment Finished Agreed /02/ /04/2017 Recruitment Finished FAST: Fast Assessment of ocular Surface Trouble 16/YH/ Safety and Efficacy of Abicipar Pegol (AGN ) in Patients With Neovascular Age-related Macular Degeneration 15/SC/ Agreed /06/ /04/2017 Recruitment Finished Agreed /06/ /04/2017 Recruitment Finished 10

11 SAFARI A month duration Phase IV prospective openlabel uncontrolled multicentre UK study in patients with neovascular namd evaluating the efficacy and safety of switching from intravitreal Alflibercept to Ranibizumab 14/SC/ Clinical performance of Compass in the diagnosis of glaucoma a comparison with HFA 15/LO/ A phase I study to evaluate the pharmacokinetics safety and tolerability of preservative free tafluprost ophthalmic solution in pediatric patients diagnosed with glaucoma or ocular hypertension 14/WM/ A Randomized, Double-Masked, Sham-Controlled, Pivotal Clinical Trial to Evaluate the Efficacy of a Single Intravitreal Injection of GS010 (raav2/2- ND4) in Subjects Affected for 6 Months or Less by Leber Hereditary Optic Neuropathy Due to the G11778A 15/LO/ Chart review of patients with confirmed geographic atrophy (GA) diagnosis secondary to age-related macular degeneration and non- GA controls 16/NI/ Agreed /10/ /03/2017 Recruitment Finished Agreed /07/ /08/2017 Recruitment Finished Agreed /06/ /07/2017 Recruitment Finished Agreed /03/ /07/2017 Recruitment Finished Agreed /08/ /07/2017 Recruitment Finished 11

12 A randomised, sham-controlled, double-masked, multi-centre study to evaluate the effect of ocriplasmin 0.125mg in subjects with non-proliferative diabetic retinopathy (NPDR) 15/EM/ An 8-week phase I/II, multicenter, randomized, double-masked, vehicle controlled parallel group study with a 48 or 56 week follow-up period to evaluate the safety and efficacy of two doses (10 Ág/ml and 20 Ág/ml) of recombinant human nerve growth fac 13/LO/ An open-label, randomized, active-controlled, parallel-group, Phase-3b study of the efficacy, safety, and tolerability of 2 mg aflibercept administered by intravitreal injections using two different treatment regimens to subjects with neovascular age 15/NE/ An open-label, randomized, active-controlled, parallel-group, Phase-3b study of the efficacy, safety, and tolerability of three different treatment regimens of 2 mg aflibercept administered by intravitreal injections to subjects with diabetic macular 16/LO/ Agreed /12/ /12/2017 Recruitment Finished Agreed /09/ /10/2017 Recruitment Finished Agreed /04/ /10/2017 Recruitment Finished Agreed /06/ /09/2017 Recruitment Finished 12

13 PANORAMA_ VGFTe-OD /SC/ A Long Term Surveillance study of Latanoprost to monitor hyperpigmentation changes in the eye in pediatric 14/LO/ A Randomized Study Comparing the Safety and Efficacy of the InnFocus MicroShunt Glaucoma Drainage system to standard trabeculectomy in subjects with primary open angle glaucoma 16/LO/ Agreed /08/ /07/2017 Recruitment Finished Agreed /07/ /04/2017 Recruitment Finished Agreed /12/ /12/2017 Recruitment Finished 13

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 patients as possible the opportunity to get