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| Sponsor: | King's College Hospital NHS Trust |
|---|---|
| Information provided by: | King's College Hospital NHS Trust |
| ClinicalTrials.gov Identifier: | NCT01006538 |
Purpose
Wet age-related macular degeneration is the most common cause of blind registration in the UK. Standard treatment involves regular eye injections of a drug called ranibizumab (Lucentis). For most patients, ranibizumab maintains their vision but the effect of the drug is temporary, and they therefore require monthly hospital visits and typically six injections into the eye every year, probably for life.
This study tests a new surgical device that delivers a focal dose of radiation (epimacular brachytherapy) to the macula (the part inside the back of the eye that gives fine central vision), to try and reduce or eliminate the need for ongoing, regular eye injections. The trial compares epimacular brachytherapy to ongoing standard treatment with ranibizumab.
Whereas most studies of this new surgical device target patients who have not yet commenced any treatment, this study targets those who are requiring frequent eye injections, as there are limited surgical resources and these resources are best directed to those who have not fully responded to ranibizumab therapy, or whose response is shortlived. These patients have the most to gain from a device that may reduce their burden of treatment. The findings in untreated disease cannot be extrapolated to this discrete subset of patients, hence the need for a study that targets refractory disease.
It is hypothesised that epimacular brachytherapy will reduce the frequency of Lucentis® (ranibizumab) re-treatment that patients require, whilst maintaining visual acuity.
| Condition | Intervention | Phase |
|---|---|---|
|
Macular Degeneration |
Device: Epimacular Brachytherapy Drug: Ranibizumab |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomised Controlled Trial 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 |
| Estimated Enrollment: | 363 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | November 2014 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm A (treatment)
Arm A: A single surgical procedure with epimacular brachytherapy using the VIDION® System, with Lucentis® (0.5 mg) administered on a monthly basis as required.
|
Device: Epimacular Brachytherapy
Strontium-90. The device delivers 24 Gray of beta radiation to the CNV lesion. Each device is calibrated for a set duration.
Other Names:
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Active Comparator: Arm B (control):
Arm B: Lucentis® (0.5 mg) administered on a monthly basis as required, using the re-treatment criteria below.
|
Drug: Ranibizumab
intravitreal injection (0.5 mg) administered on a monthly basis as required, using the re-treatment criteria
Other Names:
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Show Detailed Description
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
At the time subjects commenced anti-VEGF therapy for wet age-related macular degeneration they were aged 50 years or older and met the NICE treatment criteria for Lucentis® therapy, as outlined in the Final Appraisal Determination (FAD). This states that all of the following circumstances must apply in the eye to be treated:
Exclusion Criteria:
Contacts and Locations| Contact: Mr Timothy L Jackson, PhD FRCOphth | +44 (0)20 3299 1297 | ritidesai@nhs.net |
| United Kingdom | |
| Royal Derby Hospital | Not yet recruiting |
| Derby, Derbyshire, United Kingdom, DE22 3NE | |
| Principal Investigator: Ravi Gandhewar | |
| Royal Devon and Exeter Hospital | Recruiting |
| Exeter, Devon, United Kingdom, EX2 5DW | |
| Principal Investigator: Peter Simcock | |
| Plymouth Royal Eye Infirmary | Recruiting |
| Plymouth, Devon, United Kingdom, PL4 6PL | |
| Principal Investigator: Vasant Raman | |
| Torbay Hospital | Recruiting |
| Torquay, Devon, United Kingdom, TQ2 7AA | |
| Principal Investigator: Edward Doyle | |
| Royal Bournemouth Hospital | Recruiting |
| Bournemouth, Dorset, United Kingdom, BH7 7DW | |
| Principal Investigator: Steven Rowley | |
| Sussex Eye Hospital | Recruiting |
| Brighton, East Sussex, United Kingdom, BN2 5BF | |
| Principal Investigator: Edward Hughes | |
| Hull and East Yorks Hospital | Recruiting |
| Hull, East Yorkshire, United Kingdom, HU3 2JZ | |
| Principal Investigator: Mark Costen | |
| Essex County Hospital | Not yet recruiting |
| Colchester, Essex, United Kingdom, CO3 3SP | |
| Principal Investigator: Jignesh Patel | |
| Southend Hospital | Recruiting |
| Westcliff-on-Sea,, Essex, United Kingdom, SS0 0RY | |
| Principal Investigator: Niral Karia | |
| King's College Hospital NHS Foundation Trust | Recruiting |
| London, Greater London, United Kingdom, SE5 9RS | |
| Principal Investigator: Timothy L Jackson, PhD FRCOphth | |
| Sub-Investigator: Robert Petrarca, MBBS | |
| Manchester Royal Eye Hospital | Recruiting |
| Manchester, Greater Manchester, United Kingdom, M13 9WH | |
| Principal Investigator: Paulo Stanga | |
| Queen Alexandra Hospital | Not yet recruiting |
| Portsmouth, Hampshire, United Kingdom, PO6 3LY | |
| Principal Investigator: Yit-Fung Yang | |
| Maidstone Hospital | Recruiting |
| Maidstone, Kent, United Kingdom, ME16 9QQ | |
| Principal Investigator: Luke Membrey | |
| Ashford William Harvey Hospital | Not yet recruiting |
| Willesborough, Kent, United Kingdom, TN24 0LZ | |
| Principal Investigator: Wallance Poon | |
| Royal Liverpool Hospital | Recruiting |
| Liverpool, Merseyside, United Kingdom, L7 8XP | |
| Principal Investigator: Heinrich Heimann | |
| Arrowe Park Hospital | Recruiting |
| Upton, Merseyside, United Kingdom, CH49 5PE | |
| Contact: Som Prasad | |
| Principal Investigator: Som Prasad | |
| Queen Elizabeth Hospital King's Lynn NHS Trust | Not yet recruiting |
| King's Lynn, Norfolk, United Kingdom, PE30 4ET | |
| Principal Investigator: Manzar Saeed | |
| James Cook Hospital | Recruiting |
| Middlesborough, North Yorkshire, United Kingdom, TS4 3BW | |
| Principal Investigator: Ibraheem Elghrably | |
| John Radcliffe Hospital | Not yet recruiting |
| Headington, Oxford, United Kingdom, OX3 9DU | |
| Principal Investigator: C K Patel | |
| Royal Berkshire Hospital | Not yet recruiting |
| Reading, Royal Berkshire, United Kingdom, RG1 5AN | |
| Principal Investigator: Vaughan Tanner | |
| Royal Hallamshire Hospital | Not yet recruiting |
| Sheffield, South Yorkshire, United Kingdom, S10 2JF | |
| Principal Investigator: Richard Sheard | |
| Southampton Hospital | Not yet recruiting |
| Shirley, Southampton, United Kingdom, SO16 6YD | |
| Principal Investigator: Andrew Lotery | |
| Royal Victoria Infirmary | Recruiting |
| Newcastle, Tyne and Wear, United Kingdom, NE1 4LP | |
| Principal Investigator: Rajan Gupta | |
| Sunderland Eye Infimary | Recruiting |
| Sunderland, Tyne and Wear, United Kingdom, SR2 9HP | |
| Principal Investigator: David Steel | |
| Warwick Hospital Eye Unit | Recruiting |
| Warwick, Warwickshire, United Kingdom, CV34 5BW | |
| Principal Investigator: Anthony O'Driscoll | |
| Birmingham City Hospital (Birmingham & Midland Eye Centre) | Not yet recruiting |
| Birmingham, West Midlands, United Kingdom, B18 7QH | |
| Principal Investigator: Ajai Tyagi | |
| St James University Hospital | Recruiting |
| Leeds, West Yorkshire, United Kingdom, LS9 7TF | |
| Principal Investigator: Fiona Bishop | |
| Royal Victoria Hospital | Not yet recruiting |
| Belfast, United Kingdom, BT12 6BA | |
| Principal Investigator: Wing C Chan | |
| Bristol Eye Hospital | Recruiting |
| Bristol, United Kingdom, BS1 2LX | |
| Principal Investigator: Richard Haynes | |
| Principal Investigator: | Timothy L Jackson, PhD FRCOphth | King's College Hospital NHS Trust |
More Information
| Responsible Party: | Mr Tim Jackson, King's College Hospital |
| ClinicalTrials.gov Identifier: | NCT01006538 History of Changes |
| Other Study ID Numbers: | 09/HO206/20, 2009-012509-20 |
| Study First Received: | November 2, 2009 |
| Last Updated: | August 16, 2011 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency; United Kingdom: Research Ethics Committee |
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Wet Age-related Macular Degeneration Predominantly classic Minimally classic Occult with no classic Retinal Angiomatous Proliferation (RAP) lesions |
|
Macular Degeneration Choroidal Neovascularization Retinal Degeneration Retinal Diseases Eye Diseases |
Choroid Diseases Uveal Diseases Neovascularization, Pathologic Metaplasia Pathologic Processes |