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,

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Approved: 28/01/2015 Ratified: 28/01/2015

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: 1875 patients enrolled in clinical trials 245 research studies running and open 45 clinical trials in progress from Phase 1 to Phase 4 27 other clinical trials in progress

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Performance in Initiating Clinical Research

1

Contents

Section/Chapter Page

Table 1: Performance in Initiating Clinical Research 2

Table 2: Performance in Delivering Clinical Research 7


2

Table 1: Performance in Initiating Clinical Research 1st Jan 2014 – 31st Dec 2014 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 Research

Ethics

Committee

Reference

Number

Date of

Receipt of

Valid

Research

Applicatio

n

Date of

NHS

Permissio

n

Date of First

Patient

Recruited

Benchm

ark Met

Reason if

the study

did not

meet the

benchmark

A Multicentre Phase III Double-masked Randomised Controlled Non-Inferiority Trial comparing the clinical and cost effectiveness of intravitreal therapy with ranibizumab (Lucentis) vs aflibercept (Eylea) vs bevacizumab (Avastin) for Macular Oedema due to Central Retinal Vein Occlusion (CRVO).

14/LO/1043 14/LO/1043 21/11/2014 03/12/2014 Yes

VITAL - individualising therapy for neovascular AMD with aflibercept

14/LO/1561 14/LO/1561 30/10/2014 17/11/2014 Yes

A randomised controlled trial of adjunctive intraocular and periocular steroid (triamcinolone acetonide) versus standard treatment in eyes undergoing vitreoretinal surgery for open globe trauma

14/LO/1428 14/LO/1428 02/10/2014 31/10/2014 Yes

SAFARI: A 6 month duration, Phase IV, prospective, open-label, uncontrolled, multi-centre UK study in patients with neovascular (nAMD) evaluating the efficacy and safety of switching from

14/SC/0262 14/SC/0262 01/10/2014 02/10/2014 Yes


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intravitreal Alflibercept to Ranibizumab. A prospective trial of simultaneous transepithelial photorefractive keratectomy and corneal collagen cross-linking for keratoconus

14/SC/0264 10/06/2014 11/06/2014 18/08/2014 Yes

ECLIPSE: Fovista and Lucentis compared to Lucentis® alone in patients with AMD

13/LO/1686 06/05/2014 16/05/2014 11/07/2014 Yes

Post-market clinical follow-up investigation of the marketed Extended Range of Vision IOL

14/LO/0490 16/06/2014 31/07/2014 12/08/2014 Yes

Tangent vs bowl perimetry: an exploratory study

11/SC/0534 22/08/2014 15/09/2014 07/10/2014 Yes

Clinical evaluation of the AqueSys XEN implant in mild to moderate open angle glaucoma subjects

14/EE/0059 27/06/2014 29/07/2014 12/08/2014 Yes

CLEOPATRA (Lightmask) 13/LO/0145 26/02/2014 01/04/2014 10/04/2014 Yes A 12 month, phase IIIb, randomised, visual acuity assessor-masked, multicentre study assessing the efficacy 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)

14/EM/0001 28/03/2014 04/04/2014 06/05/2014 Yes

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 Non-

13/LO/1320 07/03/2014 14/03/2014 09/04/2014 Yes


4

Infectious Uveitis Affecting The Posterior Segment Of The Eye

An assessment of the the RAPDx pupillometer investigating test-retest reliability, and strength of associations between relative afferent pupil defect magnitude and measures of structure and function in patients with different subtypes of glaucoma and other optic neuropathies

14/EM/1011 04/06/2014 18/06/2014 04/07/2014 Yes

Evaluation of Clinical Outcomes Following Treatment with Systane Balance in Dry Eye Subjects with Lipid Deficiency

13/EE/0403 26/02/2014 28/02/2014 26/03/2014 Yes

Clinical Efficacy and Mechanistic Evaluation of Aflibercept for Proliferative Diabetic Retinopathy (acronym CLARITY). A Multicentre Phase IIb Randomised Active-Controlled Clinical trial

14/LO/0203 23/07/2014 07/08/2014 19/08/2014 Yes

A randomized, double-masked, placebo-controlled, efficacy 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 disease (TED)

14/LO/0543 14/07/2014 15/07/2014 05/08/2014 Yes


5

BP28936 - A MULTIPLE-CENTER, NON-RANDOMIZED, OPEN-LABEL, SINGLE-ASCENDING-DOSE, PARALLEL STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, SYSTEMIC PHARMACOKINETICS AND PHARMACODYNAMICS OF RO6867461 FOLLOWING INTRAVITREAL ADMINISTRATION IN PATIENTS WITH WET AGE-RELATED MACULAR DEGENERATION.

13/NE/0294 14/02/2014 14/02/2014 04/03/2014 Yes

A phase I study to evaluate the pharmacokinetics, safety and tolerability of preservative free tafluprost ophthalmic solution (0.0015%) in pediatric patients diagnosed with glaucoma or ocular hypertension

14/WM/1065 14/WM/1065

13/11/2014 21/11/2014 Within 70 Days

Monoprost compared with Lumigan in POA glaucoma/ocular hypertension

13/EM/0348 23/04/2014 29/04/2014 NOT SET No No eligible patients

Randomized trial of wide-field guided PRP for diabetic macular oedema (DMO) treated with Ranibizumab. (Ranibizumab for DMO PRP trial (RDP trial))

13/NE/0197 27/05/2014 10/06/2014 19/11/2014 No No eligible patients

Eyeguard A - A RandomizEd, Double-masked, Placebo-controlled Study of the SafetY and Efficacy of GevokizUmAb in the TReatment of Active Non-infectious

13/LO/0716 20/06/2014 13/08/2014 NOT SET No Permissions delayed Sponsor delays No eligible patients


6

IntermeDiate, Posterior, or Pan- Uveitis(CL3-78989-005.)

Rare Disease

Eyeguard C - A double-masked, placebo controlled study in patients with controlled NIU

13/LO/0717 26/06/2014 13/08/2014 17/11/2014 No Permissions delayed Sponsor delays No eligible patients Rare Disease

Recognition perimetry using high pass filtered letter targets in normal subjects and patients with glaucoma

14/LO/0167 19/02/2014 11/04/2014 07/05/2014 No Permissions delayed

Exploratory Study of a binocular therapy for strabismic and mixed amblyopia: home-based "BBV treatment" for children

14/LO/0569 10/04/2014 12/05/2014 25/06/2014 No No patients consented

Non-contact screening methods for the detection of narrow anterior chamber angles

13/LO/1923 11/02/2014 28/02/2014 23/04/2014 No No eligible patients Out of hours clinic resource

Table 2: Performance in Delivering Clinical Research 1st Jan 2014 – 31st Dec 2014 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.


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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 No)

Post-market clinical follow-up investigation of the marketed Extended Range of Vision IOL

14/LO/0490 4 05/09/2014 Closed - In Follow Up

Y

Clinical evaluation of the AqueSys XEN implant in mild to moderate open angle glaucoma subjects

14/EE/0059 5 01/06/2015 Closed - In Follow Up

Y

A randomized, double-masked, placebo-controlled, efficacy 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 disease (TED)

14/LO/0543 2 01/07/2015 Open Y – Trial Still Open

A 12 month, phase IIIb, randomised, visual acuity assessor-masked, multicentre study assessing the efficacy 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)

14/EM/0001 5 17/10/2014 Closed - In Follow Up

Y

BP28936 - A MULTIPLE-CENTER, NON-RANDOMIZED, OPEN-LABEL, SINGLE-ASCENDING-DOSE, PARALLEL STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, SYSTEMIC PHARMACOKINETICS AND PHARMACODYNAMICS OF RO6867461 FOLLOWING INTRAVITREAL ADMINISTRATION IN PATIENTS WITH WET AGE-RELATED MACULAR DEGENERATION.

13/NE/0294 2 31/12/2014 Closed - Follow Up Complete

Y


8

2 year use of Aflibercept study for treatment of wet AMD


Y

Distance of Choroid- DOCS 13/LO/0951 40 31/07/2014 Closed - Follow Up Complete

Y

BOL-303259-X 0.024% (Latanoprostene Bunoda) ophthalmic solution vs. Timolol Maleate ophthalmic solution 0.5% (Safety and efficacy study in adults) (LUNAR)

14/ES/1006 1 25/04/2014 Closed - Follow Up Complete

Y

Eyeguard B - A double-masked, placebo controlled study in patients with Behcet’s Disease Uveitis


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


Y

OCTAVE 13/LO/0520 4 16/04/2016 Closed - In Follow Up

Y

REPARO: 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 µg/ml and 20 µg/ml) of recombinant human nerve


3 month, multicenter, double-masked safety and efficacy study of Travoprost Ophthalmic Solution, 0.004% compared to Timolol (0.5% or 0.25%) in paediatric glaucoma patients


Y

CONSTANCE - Ozurdex PASS 12/YH/0231 10 31/03/2016 Closed - In Follow Up

Y


9

An open-label study to evaluate the effects of repeated treatments of oral QLT091001 on safety and vision outcome in subjects with LCA or RP due to inherited deficiencies in RPE65 or LRAT. Extension study

12/LO/0829 5 15/01/2014 Closed - Follow Up Complete

Y

Study to validate optical coherence tomography in Patients with MS


Y

BRIGHTER: A 24 month, phase IIIb, open label, randomised, active-controlled, 3 arm, multicentre study assessing the efficacy and safety of an individualised, stabilisation-criteria-driven PRN dosing regime with 0.5mg ranibizumab intravitreal injections applied

12/SC/0025 7 01/06/2013 Closed - In Follow Up

Y

CRYSTAL: A 24 month, phase IIIb, open label, single-arm, multicentre study assessing the efficacy and safety of an individualised, stabilisation-criteria-driven PRN dosing regime with 0.5mg ranibizumab intravitreal injections applied as monotherapy in patients with visual impairment due to central retinal vein occlusion )


Y

LUMINOUS: Study to observe the effectiveness and safety of LUCENTIS through individualised patient treatement and associated outcomes

11/YH/0140 800 19/06/2016 Closed - In Follow Up

Y

A Phase I/II, open label, multi-centre, prospective study to determine the 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 12 30/04/2015 Closed - In Follow Up

Y

A 12 month, multi-centre parallel group study to compare the efficacy and safety of ozurdex V lucentis in patients with branch vein occlusion (BRVO) - the COMO study


Y

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-,

10/H0406/45 4 30/09/2014 Closed - Follow Up Complete

Y


10

posterior-, or pan-uveitis

A multicentre study of the efficacy 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 4 30/12/2014 Open Y – Trial Still Open

A Multicenter OpenLabel Study of the Longterm Safety and Efficacy of the Human AntiTNF Monoclonal Antibody Adalimumab in Subjects with Noninfectious Intermediate, Posterior,or Panuveitis

10/H0406/47 3 31/01/2015 Closed - In Follow Up

Y

Argus II Retinal Stimulation System Feasibility Study


Y

A6111144: Long Term Surveillance study of Latanoprost to monitor hyperpigmentation changes in the eye in pediatric populations

14/LO/0654 10 15/07/2015 Open N/A – Trial Still Open

MEMO: Patient questionnaire study 14/WS/0092 20 01/05/2016 Open N/A – Trial Still Open

Eyeguard C - A double-masked, placebo controlled study in patients with controlled NIU


A RandomizEd, Double-masked, Placebo-controlled Study of the SafetY and Efficacy of GevokizUmAb in the TReatment of Active Non-infectious IntermeDiate, Posterior, or Pan- Uveitis(CL3-78989-005.)


INJECT: Investigation of Jetrea in patients with confirmed Vitreomacular Traction



11

ECLIPSE: Fovista and Lucentis compared to Lucentis® alone in patients with AMD


Monoprost compared with Lumigan in POA glaucoma/ocular hypertension

13/EM/0348 6 30/06/2015 Open N/A – Trial Still Open

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 Non-Infectious Uveitis Affecting The Posterior Segment Of The Eye


A Phase III multicentre randomised double-blind placebo controlled study to assess the efficacy and safety of Tocilizumab in patients with Giant Cell Arteritis


Stem cell transplantation in wet AMD GTAC194 10 01/01/2015 Suspended N/A – Trial Still Open

Efficacy and Safety assessment of T4020 versus vehicle in patients with chronic 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. HARMONISATION 13/0215

13/YH/0086 2 31/12/2014 Open N/A – Trial Still Open

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

12/SW/0263 24 13/02/2016 Withdrawn N/A – Trial Still Open

A randomised, active-controlled, open-label, multiple-dose, proof of concept study of intravitreal LFG316 in patients with MFC

12/SW/0084 2 09/04/2014 Suspended N/A – Trial Still Open

Follow-up study for patients with Retinal Cells Derived from Stem Cells for Stardgart's Macular Dystrophy

GTAC198 12 09/01/2019 Open N/A – Trial Still Open


12

SAFARI: A 6 month duration, Phase IV, prospective, open-label, uncontrolled, multi-centre UK study in patients with neovascular (nAMD) evaluating the efficacy and safety of switching from intravitreal Alflibercept to Ranibizumab.

14/SC/0262 5 01/05/2015 Open N/A – Trial Still Open

A phase I study to evaluate the pharmacokinetics, safety and tolerability of preservative free tafluprost ophthalmic solution (0.0015%) in pediatric patients diagnosed with glaucoma or ocular hypertension

14/WM/1065 2 15/07/2017 Open N/A – Trial Still Open

Evaluation of Clinical Outcomes Following Treatment with Systane Balance in Dry Eye Subjects with Lipid Deficiency


N – Sponsor closed study

PROMETHEUS: A 12-month, randomized, double-masked, multicenter study to evaluate the efficacy 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)


N – patients Declined study

A randomised, double-blind, parallel-group, placebo-controlled study to assess the efficacy, safety, tolerability, and pharmacokinetics of BIIB033 in subjects with first episode of acute optic neuritis


N – Acute condition

A Phase III Multinational, Multicenter, Randomised, Double-Masked, Study Assessing the Safety and Efficacy of Intravitreal Injections of DE-109 (three doses) for the Treatment of Active, Non-infectious Uveitis of the Posterior Segment of the Eye


N - Sponsor closed study

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




13

Patients With Glaucoma

A6111143 - A Prospective, Noninterventional, longitudinal cohort study to evaluate the long-term safey of Xalatan (Latanoprost) Treatment in Paediatric Populations



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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,