A randomised controlled trial of epimacular brachytherapy versus ranibizumabmonotherapy for the treatment of subfoveal choroidal neovascularisationassociated with wet age-related macular degeneration in patients who havecommenced anti-VEGF therapy - Merlot

• Conditions: Wet age-related macular degeneration; MedDRA version: 12.0Level: LLTClassification code 10067791Term: Wet macular degeneration

• Registration Number: EUCTR2009-012509-20-GB
• Lead Sponsor: King's College Hospital NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09-17
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 363

Inclusion Criteria

Inclusion criteria

1. Subjects with subfoveal choroidal neovascularization associated with wet age-related macular degeneration. Retinal Angiomatous Proliferation (RAP) lesions
not directly involving the fovea must be associated with contiguous foveal
leakage demonstrated on fundus examination, OCT, or fluorescein angiography;

2. Subjects must have received anti-VEGF (Lucentis) induction treatment, defined as the first three months of anti-VEGF 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 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:

- the best-corrected 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)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion criteria

1. Patients who have not been treated in accordance with NICE guidance;
2. Visual acuity worse than 6/96 (24 ETDRS letters) 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 subjects with known or suspected idiopathic polypoidal choroidal vasculopathy (IPCV), 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 anti-malarial 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 follow-up examinations for three years;
23.Women must be post-menopausal <1 year unless surgically sterilized.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified