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| NB: The information displayed below does not replace the protocol. The latest protocol version should always be consulted before making clinical decisions. |
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Macular EpiRetinal brachytherapy vs Lucentis Only Treatment (MERLOT)
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Macular EpiRetinal brachytherapy versus Lucentis Only Treatment (MERLOT): A randomized controlled trial of epimacular brachytherapy using the VIDION System versus ranibizumab (Lucentis) monotherapy for the treatment of subfoveal choroidal neovascularization associated with wet agerelated macular degeneration in patients who have commenced antiVEGF
therapy
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Topic
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Eye
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Portfolio Eligibility
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Funded by UKCRC partner
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ISRCTN
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EudraCT
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2009-012509-20
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MREC N° |
09/H0206/21
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UKCRN ID |
7680
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WHO ID
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Study Type |
Interventional
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Design Type |
Not specified
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Disease(s) |
Ophthalmology
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Phase |
N/A
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Current Status
| Open |
| Closure Date | 01/08/2014 |
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Sample Size
| 363 |
| Accrual to Date |
 25% |
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Geographical Scope
| UK Multi-Centre |
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Lead Country
| England |
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Open to new sites
| -unknown- |
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Main Inclusion Criteria
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1. Subjects with subfoveal choroidal neovascularization associated with wet agerelated
macular degeneration;
2. Subjects must have received antiVEGF
induction treatment, defined as the first three months of antiVEGF
therapy.
Following this induction period, subjects must have received at least 4 additional injections of Lucentis® in no more
than 12 months preceding enrolment, or 2 additional injections of Lucentis® in no more than 6 months preceding
enrolment, given on an as needed basis;
3.At the time subjects commenced antiVEGF
therapy for wet agerelated
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:
− the bestcorrected
visual acuity is between 6/12 and 6/96 (24 to 69 ETDRS letters)
− there is no permanent structural damage to the central fovea
− the lesion size is less than or equal to 12 disc areas in greatest linear dimension
there is evidence of recent presumed disease progression (blood vessel growth, as indicated by fluorescein
angiography, or recent visual acuity changes)
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Main Exclusion Criteria
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1. Patients who have not been treated in accordance with NICE guidance;
2. Visual acuity worse than 6/96 at time of study enrolment;
3. Subjects with prior or concurrent subfoveal CNV therapy with agents, surgery or devices (other than Macugen®,
Avastin®, or Lucentis®) including thermal laser photocoagulation (with or without photographic evidence),
photodynamic therapy, intravitreal or subretinal steroids, and transpupillary thermotherapy (TTT);
4. Subfoveal scarring;
5. Subjects with active concomitant disease in the study eye, including uveitis, presence of pigment epithelial tears or
rips, acute ocular or periocular infection;
6. Subjects who have been previously diagnosed with Type 1 or Type 2 Diabetes Mellitus. Subjects who do not have a
documented diagnosis, but have retinal findings consistent with Type 1 or Type 2 Diabetes Mellitus;
7. Subjects with advanced glaucoma (greater than 0.8 cup:disk) or intraocular pressure ≥ 30 mmHg in the study eye;
8. Previous glaucoma filtering surgery in the study eye;
9. Subjects with inadequate pupillary dilation or significant media opacities in the study eye, including cataract, which
may interfere with visual acuity or the evaluation of the posterior segment;
10.Current vitreous hemorrhage in the study eye;
11.History of rhegmatogenous retinal detachment or macular hole in the study eye;
12.Subjects who present with CNV due to causes other than AMD, including ocular histoplasmosis syndrome, angioid
streaks, multifocal choroiditis, choroidal rupture, or pathologic myopia (spherical equivalent ≥ 8 Dioptre or axial length
≥ 25mm);
13.Subjects who have undergone any intraocular surgery in the study eye within 12 weeks prior to the screening visit,
with the exception of cataract surgery as discussed in the Exclusion Criteria #14;
14.Previous cataract surgery within 2 months prior to enrollment into the study;
15.Subjects with known serious allergies to fluorescein dye used in angiography;
16.Subjects with known sensitivity or allergy to Lucentis®;
17.Subjects who underwent previous radiation therapy to the eye, head or neck;
18.Subjects with an intravitreal device or drug in the study eye;
19.Subjects with any other condition, which in the judgment of the investigator would prevent the subject from
completing the study (e.g. documented diagnosis of dementia or serious mental illness);
20.Current participation in another drug or device clinical trial, or participation in such a clinical trial within the last year;
21.History of use of drugs with known retinal toxicity, including: chloroquine (Aralen – an antimalarial
drug),
hydroxychloriquine (Plaquenil), phenothiazines, chlorpromazine (Thorazine), thioridazine (Mellaril), fluphenazine
(Prolixin), perphenazine (Trilafon), and trifluoperazine (Stelazine);
22.Subjects who are unwilling or unable to return for scheduled treatment and followup
examinations for three years;
23.Women must be postmenopausal
>1 year unless surgically sterilized
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Chief Investigator(s)
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| Mr Tomothy L Jackson |
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Further details, please contact
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Mrs Barbara Kolator
King's College Hospital
Department of Ophthalmology
Denmark Hill
London
SE5 9RS
UNITED KINGDOM
Tel: 0203 299 1297
barbara.kolator@kch.nhs.uk
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Funder(s) |
NeoVista
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Sponsor(s) |
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