Performance in Initiating and Delivering Clinical Research

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Eleanor Woods
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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: 322 research studies running and open 49 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: Performance in Initiating Clinical Research 2 Table 2: Performance in Delivering Clinical Research 6 2

3 Table 1: Performance in Initiating Clinical Research 1 st April st March 2018 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 Date Site Confirmed Date Ready to Start First Recruit Date Reason if not hit benchmark Source of Delay 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 3

4 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/ /01/ /05/ /06/ /08/ /07/ /07/ /11/2017 Delays Delays 4

5 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/ /12/2017 Delays, Permissons Delays 5

6 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 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 No Patients Consented Neither 6

7 THE HYDRUS MICROSTENT FOR REFRACTORY OPEN?ANGLE GLAUCOMA: A PROSPECTIVE, MULTICENTER CLINICAL TRIAL (HYDRUS VII STUDY) /NS/ /10/ /12/ /12/ /02/ /02/ /02/2018 Randomized controlled trial comparing the use of Hilotherm cooling system with standard care in the postoperative treatment of bilateral Adnexal surgeries /LO/ /12/ /01/ /01/ /01/ /01/ /01/2018 Contracting Delays Staff availability and equipment delays Neither 7

8 Table 2: Performance in Delivering Clinical Research 1 st April st March 2018 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. 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/ 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 of patients recruited by target date The total number of study particip ants recruite d Date trial closed Reason Trial Closed to to recruitment Recruitment Agreed /03/ /05/2017 Recruitment Finished 8

9 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 /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/ 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/ Agreed /06/ /04/2017 Recruitment Finished Agreed /06/ /04/2017 Recruitment Finished Agreed /07/ /08/2017 Recruitment Finished Agreed /06/ /07/2017 Recruitment Finished 9

10 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/ 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/ Agreed /03/ /07/2017 Recruitment Finished Agreed /08/ /07/2017 Recruitment Finished Agreed /12/ /12/2017 Recruitment Finished Agreed /09/ /10/2017 Recruitment Finished 10

11 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 /04/ /10/2017 Recruitment Finished Agreed /06/ /09/2017 Recruitment Finished 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 11

12 Randomized, double-blind, placebo-controlled exploratory study to evaluate pharmacodynamics, safety and tolerability of orally administered BI for 12 weeks in patients with visual impairment due to central-involved diabetic macular edema (DME 16/LO/ Agreed /06/ /06/2017 Recruitment Finished 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 patients as possible the opportunity to get