Performance in Initiating and Delivering Clinical Research

Transcription

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: 272 research studies running and open 42 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 October th September 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 Clinical efficacy and mechanistic evaluation of Eplerenone for Central serous chorio-retinopathy û the VICI randomised trial WA /02/ /10/ /07/ /12/ /12/ /12/ /12/2016 3

4 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 4

5 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 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 5

6 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 Randomized controlled trial comparing the use of Hilotherm cooling system with standard care in the postoperative treatment of bilateral Adnexal surgeries /LO/ /12/ /09/ /01/ /09/ /09/ /09/2017 Not Yet Recruited 6

7 Diabetic Macular Oedema and Diode Subthreshold Micropulse Laser (DIAMONDS): A pragmatic, multicenter, allocation concealed, prospective, randomised, noninferiority doublemasked trial /NI/ /12/ /12/ /11/ /01/ /01/ /01/ /04/2017 External natural history controlled, open-label intervention study to assess the efficacy and safety of long-term treatment with Raxone«in LeberÆs hereditary optic neuropathy (LHON) /NE/ /02/ /10/ /10/ /02/ /01/ /01/ /04/2017 Staff Availability Sponsor Delay NHS SPONSOR 7

8 EFFICACY AND SAFETY ASSESSMENT OF T1580 VERSUS VEHICLE IN DRY EYE DISEASE TREATMENT /LO/ /04/ /12/ /12/ /01/ /01/ /02/2017 Not Yet Recruited 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 Sponsor Delay Sponsor Delay SPONSOR SPONSOR 8

9 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/ /08/2017 Not Yet Recruited Sponsor Delay / Permissions delayed SPONSOR 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 Not Yet Recruited Sponsor Delay SPONSOR 9

10 MULTINATIONAL, MULTICENTRE, PROSPECTIVE, OPEN-LABEL, UNCONTROLLED CLINICAL TRIAL TO ASSESS THE EFFICACY AND SAFETY OF AUTOLOGOUS CULTIVATED LIMBAL STEM CELLS TRANSPLANTATIO N (ACLSCT) FOR RESTORATION OF CORNEAL EPITHELIUM IN PATIENTS WITH LIMBAL STEM CELL DEFICIENCY DUE TO OCULAR BURNS (HOLOCORE) /LO/ /02/ /04/ /07/ /08/ /06/ /08/2017 Not Yet Recruited Sponsor Delay SPONSOR 10

11 Table 2: Performance in Delivering Clinical Research 1 st October th September 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. An week phase III multicenter randomized doublemasked vehicle controlled parallel group study with a or week followup period to evaluate the safety and efficacy of two doses Ágml and Ágml of recombinant human nerve growth factor eye drops 13/LO/ Target number of patients agreed Min Target no. of patients Max Target number of patients Agreed 4 4 If Agreed, Date Agreed to recruit target number of patients of patients recruite d by target date The total number of study participants recruited Date trial closed to recruitment 01/09/201 Reason Trial Closed to Recruitment /10/2016 Recruitment Finished 11

12 CLFG316A2204: A randomized, active-controlled, open-label, multiple-dose, proof-of-concept study of intravitreal LFG316 in patients with active noninfectious intermediate-, posterior-, or panuveitis requiring systemic immunosuppressive therapy 12/SW/ A Multicenter, Follow-Up Study to Assess Long-Term Electrophysiologic and Clinical Outcomes in Subjects Previously Enrolled in Study 215ON201 16/WS/ Long Term, Open-Label, safety Follow Up Study Following Transplantation of PF (Human Embryonic Stem Cell Deived Retinal Pigment Ephithelium (RPE)) in Subjects with Acute Wet Age Related Macular Degeneration and Recent Rapid Vision Decline 16/LO/ A phase III, multicenter, randomised, double-masked, sham-controlled study to assess the efficacy and safety of Lampalizumab administered intravitreally to patients with GA secondary to AMD 14/SC/ Agreed 2 2 Agreed 1 1 Agreed 2 2 Agreed /12/ /11/2016 Recruitment Finished 31/10/ /10/2016 Recruitment Finished 31/10/ /10/2016 Recruitment Finished 01/09/ /10/2016 Recruitment Finished 12

13 BEACON: Safety and Efficacy of Brimonidine Posterior Segment Drug Delivery System in Patients with Geographic Atrophy Secondary to AMD 15/LO/ Agreed /08/ /10/2016 Recruitment Finished GX /NE/ Compensation for blindness with the Intelligent Retinal Implant System (IRIS) in patients with retinal dystrophy 16/LO/ 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 Mitochondrial NADH Dehydrogenase Gene 15/LO/ 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/ Agreed 4 4 Agreed 3 3 Agreed 5 5 Agreed 5 5 Agreed /03/ /01/2017 Recruitment Finished 31/12/ /12/2016 Recruitment Finished 01/12/ /03/2017 Recruitment Finished 31/03/ /05/2017 Recruitment Finished 30/04/ /10/2017 Recruitment Finished

14 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 LUBRICANT THERAPY AND A 3-MONTH POST- TREATMENT SAFETY FOLLOW- UP IN MODERATE TO SEVERE DRY EYE PATIENTS 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/ 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/ Agreed Agreed 5 5 Agreed 5 5 Agreed /06/ /04/2017 Recruitment Finished 30/06/ /04/2017 Recruitment Finished 31/10/ /03/2017 Recruitment Finished 31/07/ /08/2017 Recruitment Finished

15 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 Mutation in the Mitochondrial NADH Dehydrogenase 4 Gene 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 2 2 Agreed 5 5 Agreed /06/ /07/2017 Recruitment Finished 31/03/ /07/2017 Recruitment Finished 24/08/ /07/2017 Recruitment Finished 15