Studies

The following are some of the studies in which NetwORC UK has been involved since our inception in 2004. More information is available by clicking on the study name.

VPDT Cohort

The Verteporfin Photodynamic Therapy (VPDT) cohort study evaluated visual and economic outcomes in patients with subfoveal choroidal neovascularisation undergoing Photodynamic Therapy (PDT) within the UK National Health Service (NHS). This three-year study at the London School of Hygiene and Tropical Medicine was funded by the Department of Health.

CARMA

The Celtic Age-Related Maculopathy study looked at the effects of carotenoids on early signs of age-related macular degeneration. The study was carried out at the Royal Victoria Hospital, Belfast, Northern Ireland and Waterford Regional Hospital, County Waterford, Republic of Ireland.

Indeye

The INDEYE study was a collaborative study between the Department of Non Communicable Diseases at the London School of Hygiene and Tropical Medicine, Aravind Eye Hospital Madurai, All India Institute of Medical Sciences Delhi, the Centre for Vision and Vascular Science Queen's University Belfast and the University of Parma. The objectives of the INDEYE study were to investigate genetic, nutritional and environmental risk factors for age-related macular degeneration and cataract. The INDEYE Study was funded by the Wellcome Trust.

Ivan

A randomised controlled trial of alternative treatments to inhibit VEGF in patients with age-related choroidal neovascularisation. A head-to-head comparison of the efficacy and safety of two anti-VEGF drugs, Avastin® and Lucentis®, the trial also studied whether the number of treatments required could be reduced. Study results have been published in The Lancet.

ABC Avastin

A randomised, double-masked Phase III/IV study by Moorfields Eye Hospital NHS Foundation Trust of the efficacy and safety of Avastin® intravitreal injections compared to best available therapy in subjects with choroidal neovascularisation secondary to age-related macular degeneration.

Perspectives

A 102 week, open label trial which investigated the efficacy of treating early choroidal neovascularisation with pegaptanib sodium in patients with neovascular age-related macular degeneration.

Irish Nun Eye Study (INES)

Funded by HPSSNI R&D and sponsored by the Belfast Health and Social Care Trust, the INES investigated the prevalence of age-related maculopathy in a population with a restricted lifestyle with particular focus on exposure to solar radiation.

SolDR

A one year, placebo-controlled, randomised study to evaluate the effect of Choline Fenofibrate (ABT-335/SLV348) on macular edema measured by optical coherence tomography in subjects with diabetic macular edema.

INTREPID

A double-masked, sham controlled study by Oraya Pharmaceuticals to evaluate the safety and effectiveness of low voltage stereotactic radiosurgery in patients with choroidal neovascularisation secondary to age-related macular degeneration.

Merlot

A King's College Hospital study of epimacular brachytherapy versus ranibizumab monotherapy for the treatment of subfoveal choroidal neovascularisation associated with wet age-related macular degeneration in patients who have commenced anti-VEGF therapy.

TANDEM

A randomised controlled trial of high and low dose Avastin® for neovascular macular degeneration in the East Midlands.

ECHoES

The Effectiveness of Community versus Hospital Eye Service follow-up for patients with neovascular age-related macular degeneration with quiescent disease: a virtual trial.

RELIGHT

Funded by Novartis, RELIGHT is a UK, 18-month, prospective, open-label, multicentre, single-arm Phase IIIb study, with 12-month primary endpoint, assessing the efficacy and safety of Lucentis® (Ranibizumab) in patients with visual impairment due to diabetic macular oedema.

EAGLE

EAGLE is funded by the Medical Research Council (MRC) and managed by the National Institute for Health Research (NIHR) on behalf of the MRC-NIHR partnership. It is a randomised controlled trial investigating the effectiveness of early lens extraction with intraocular lens implantation for the treatment of primary angle closure glaucoma.

NICOLA

Northern Ireland Cohort Longitudinal Study on Ageing (NICOLA) is a ten year study of 8500 people. NetwORC UK is analysing ocular data and its relationship with demographic, lifestyle, genetic and biochemical data to better understand the etiology and pathophysiology involved in ocular ageing and age-related ocular diseases.

CLARITY

A multi-centre Phase IIb randomised active-controlled clinical trial by Moorfields Eye Hospital NHS Foundation Trust investigating clinical efficacy and mechanistic evaluation of Aflibercept for proliferative diabetic retinopathy.

LEAVO

An NIHR funded multi-centre Phase III double-masked randomised controlled non-inferiority trial, sponsored by Moorfields Eye Hospital NHS Foundation Trust and managed by the Kings accredited CTU, 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).

RDP

An investigator-led multi-centre study, funded by Novartis, sponsored by Newcastle upon Tyne Hospitals NHS Trust. RDP is a randomized trial of wide-field guided PRP for diabetic macular oedema (DMO) treated with Ranibizumab, in patients with peripheral ischaemia.

STAR

StereoTactic radiotherapy for wet Age-Related macular degeneration (STAR) is a randomised, double-masked, sham-controlled, clinical trial by King's College London (the lead sponsors) comparing low-voltage X-ray irradiation with as needed ranibizumab, to as needed ranibizumab monotherapy.

EDNA

Early Detection of Neovascular Age-related macular degeneration (AMD) is a UK collaborative study funded by the NIHR Health Technology Assessment Programme. The study aims to identify the optimum non-invasive test strategy to detect nAMD in unaffected fellow eyes during follow-up secondary care of people with nAMD in one eye.

FASBAT

Observing Fibrosis, Macular Atrophy and Sub retinal Highly Reflective Material – Before and After Intervention with Anti-VEGF Treatment. This is an extension to the EDNA Study.

IVAN FOLLOW-UP

This is a five year observational follow-up of the IVAN trial cohort. This study aims to follow up participants in the Inhibition of VEGF in Age-related choroidal Neovascularisation (IVAN) trial to answer additional research questions of major importance to the UK National Health Service (NHS) about the management of wet age-related macular degeneration (AMD) in the longer term.

PROMO

A comparative proteomic approach to identify novel biomarkers for diabetic macular oedema and retinal vein occlusion.

RAP

To establish the response of RAP as part of a wet AMD treatment protocol with anti-VEGF agents by performing a retrospective audit of identified cases. The aim of the study is to independently validate the diagnosis and grading of the RAP component.

VICI

Clinical efficacy and mechanistic evaluation of Eplerenone for central serous chorio-retinopathy. Central serous chorio-retinopathy (CSCR) is a poorly understood eye disease.

EMERALD

Effectiveness of Multimodal imaging for the Evaluation of Retinal oedema and new vessels in Diabetic retinopathy. The aim of this study is to determine the diagnostic performance and cost-effectiveness of a new form of surveillance (ophthalmic grader pathway) for people with stable DMO and/or PDR, using the current standard of care as the reference standard.

DIAMONDS

Diabetic Macular Oedema and Diode Subthreshold micropulse laser. A pragmatic, multicentre, allocation concealed, prospective, randomised, non-inferiority double masked trial.

UK BIOBANK

Involving a study group 68,540 participants, NetwORC UK in collaboration with Professor Paul Foster is assessing retinal images initially for disease of the macula, disease of the optic disc and disease of the mid peripheral retina. Stage two of the study involves a detailed grading of any cases with signs of diabetic retinopathy, age related macular degeneration and glaucoma. Funding has been provided by Fight for Sight (normal/abnormal and DR grading), Macular Society (AMD grading) and the Special Trustees of Moorfields Eye Hospital (Glaucoma grading).

RPE65 MGT003

One of the MEIRA portfolio of studies, MGT003 Gene Therapy Trial for LCA OPTIRPE65 is an open label multi-centre Phase I/II dose escalation trial of an adeno-associated virus vector (AAV2/5-OPTIRPE65) for gene therapy of adults and children with retinal dystrophy associated with defects in RPE65 (LCA2).

RPE65 MGT004

One of the MEIRA portfolio of studies, MGT004 Long-Term Follow-Up Gene Therapy Study for LCA OPTIRPE65 is a long-term follow-up study of participants following an open label, multi-centre, Phase I/II dose escalation trial of an adeno-associated virus vector (AAV2/5-OPTIRPE65) for gene therapy of adults and children with retinal dystrophy due to RPE65 deficiency (LCA2).

RPE65 MGT005

One of the MEIRA portfolio of studies, MGT005 Natural History Study is a study of patients with Leber Congenital Amaurosis associated with mutations in RPE65.

CNGB3 MGT006

One of the MEIRA portfolio of studies, MGT006 Gene Therapy Trial for Achromatopsia (CNGB3) is an open label multi-centre 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 CNGB3.

CNGB3 MGT007

One of the MEIRA portfolio of studies, MGT007 Long-Term Follow-Up Gene Therapy Study for Achromatopsia (CNGB3) is a long-term follow-up study of participants following an open label, multi-centre, 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 CNGB3.

RPGR MGT009

One of the MEIRA portfolio of studies, MGT009 Gene Therapy Trial for XLRP RPGR is 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).

RPGR MGT010

One of the MEIRA portfolio of studies, MGT010 Long-Term Follow-Up Gene Therapy Study for XLRP RPGR is a long-term follow-up study of participants following 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).

RPGR MGT011

One of the MEIRA portfolio of studies, MGT011 Natural History Study is a study of patients with X-linked Retinal Dystrophy Associated with Mutations in Retinitis Pigmentosa GTPase Regulator (RPGR).

MEIRA MGT012

One of the MEIRA portfolio of studies, MGT012 Gene Therapy for Achromatopsia (CNGA3) is an open label, multi-centre, Phase I/II dose escalation trial of a recombinant adeno-associated virus vector (AAV2/8-hG1.7p.cohCNGA3) for gene therapy of adults and children with achromatopsia owing to defects in CNGA3.

TAGS

Treatment of Advanced Glaucoma Study (TAGS) is a multicentre randomised controlled trial comparing primary medical treatment with primary trabeculectomy for people with newly diagnosed advanced glaucoma. Grading of visual fields.

MONARCH

Monitoring for neovascular Age-related macular degeneration (AMD) Reactivation at Home. MONARCH is a diagnostic test accuracy study investigating how well three vision tests completed by participants at home (called home monitoring tests) can detect when AMD requires treatment, compared to the gold standard of clinical assessment in hospital eye clinics.

ARIS

The AMD Ryan Initiative Study (ARIS) is a longitudinal study of early AMD and reticular pseudodrusen. It is designed as a multi-centre, international, prospective, observational cohort study of participants who will undergo clinical assessments, multi-modal imaging and receive the standard of care as determined by the participant’s ophthalmologist.

AREDS2 10-Year Follow On

For AREDS2 (Age-Related Eye Disease Study 2) participants completed clinical trial data collection by 31 October 2012. The AREDS2 10-Year Follow On study involves the collection of additional Optos Colour imaging and data during a one-time, in-clinic visit for approximately 1,200 participants at selected AREDS2 clinical sites.

AREDS Optic Disc Grading

The aim of the project is to increase access to retinal image interpretation through citizen science, via a crowdsourcing grant, and to analyse optic nerve images from the AREDS participants.

OPTOS SEQUOIA

Grading of study images to determine presence of diabetic retinopathy. Images with diabetic retinopathy are graded as per International Diabetic Classification Scale and presence or absence of DME. Images without diabetic retinopathy are graded as normal or as one of defined set of other referable pathologies.

ILM Peeling Study

A pilot RCT of ILM peeling in macular hole surgery; evaluating the new Alcon/Grieshaber ‘Shark skin’ Finesse forceps compared to existing forceps. An investigator initiated trial led by Dr. David Steele of Newcastle University.

COMMONWEALTH EYE HEALTH CONSORTIUM PEEK PROJECT

Funded by the Queen Elizabeth Diamond Jubilee Trust and supported by the London School of Hygiene and Tropical Medicine. Grading and quality control of PEEK retina images for various validation studies and other potential imaging devices.

REACH-DR

An MRC research grant to establish a teleophthalmology programme for a diabetic retinopathy screening programme. UK-Philippines Remote Retinal Evaluation Collaboration in Health: Diabetic Retinopathy.

 
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