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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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27 November 2017 |
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Main ID: |
ISRCTN34410935 |
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Date of registration:
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30/05/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Combination therapy of Visudyne, Minocycline, Dexamethasone and Ranibizumab (VIMDER) for the treatment of subfoveal choroidal neovascularisation (CNV)
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Scientific title:
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A pilot study to examine the safety and efficacy of intravitreal ranubizumab/dexamethasone administration and oral minocycline in addition to Visudyne (verteporfin) photodynamic therapy for subfoveal choroidal neovascularization secondary to age-related macular degeneration: an open-label trial |
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Date of first enrolment:
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01/06/2007 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN34410935 |
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Study type:
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Interventional |
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Study design:
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Non-randomised, non-controlled pilot trial (Treatment)
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Phase:
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Not Specified
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Victor
Chong |
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Address:
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King's College Hospital
Denmark Hill
SE5 9RS
London
United Kingdom |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. The patient must be willing to give written informed consent
2. The patient must be able to undertake the necessary tests and treatment and be willing to be followed up
3. Age 50 years or older
4. Clinical diagnosis of AMD
5. Subfoveal CNV confirmed by fluorescein angiography
6. Logarithmic minimal angle of resolution (LogMAR) best corrected visual acuity of 24 - 73 letters on early treatment diabetic retinopathy study (ETDRS) chart
Exclusion criteria: 1. Inability to understand or sign consent form
2. The patient has a current medical condition or history of a medical condition that would be likely to preclude scheduled study visits such as unstable angina, dialysis, and active cancer
3. Patient has a current ophthalmic condition or history of an ophthalmic condition that might compromise the assessment of the treatment such as diabetic retinopathy, uveitis, amblyopia, ischaemic optic neuropathy
4. Signs of a myopic retina or refraction of greater than -8 dioptres in their current or any previous glasses prescription
5. Signs of other retinal conditions that may have caused the CNV such as angioid streaks, choroidal rupture, and old chorio-retinitis
6. Open angle glaucoma
7. At increased risk of developing glaucoma such as having pigment dispersion syndrome or pseudoexfoliation
8. Unable to have a good quality fluorescein angiogram taken, e.g., due to head tremor or media opacity
9. Known hypersensitivity to fluorescein or any of the study medications
10. Previous treatment for a retinal detachment
11. Judged by the examining clinician to be at increased risk of retinal detachment due to weaknesses in the peripheral retina
12. Previous photodynamic therapy or other therapy for a CNV including argon laser treatment
13. Patient is currently participating or has participated in a clinical trial that utilised an investigational drug or treatment within 30 days prior to enrolment to this study
14. On anticoagulation therapy such as warfarin, with the exception of aspirin and other anti-platelet therapy
15. Exclusion of women of childbearing potential
16. Exclusion of pregnant or lactating women
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Age-related macular degeneration
Eye Diseases
Age-related macular degeneration
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Intervention(s)
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Patients will receive a reduced light dose (25 J/cm^2) verteporfin photodynamic therapy, and an intravitreal injection of 0.3 mg ranibizumab and 200 µg dexamethasone at their first visit. Minocycline 100 mg taken orally (p.o) will be taken daily for three months. Duration of follow up is one year.
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Primary Outcome(s)
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Evaluate the changes in visual acuity from baseline at 12 months in patients treated with intravitreal ranibizumab in combination with verteporfin photodynamic therapy.
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Secondary Outcome(s)
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1. Mean change from baseline in best corrected visual acuity (BCVA) at month six
2. Proportion of patients who gain greater than or equal to 5, 10, 15 letters of BCVA from baseline at months 6 and 12
3. Proportion of patients who lose less than 15 letters of BCVA from baseline at months 6 and 12
4. Mean change from baseline in total size of lesion and total size of CNV at 3, 6, and 12 months
5. Change in area of leakage at 3, 6 and 12 months
6. Total number of treatments of Lucentis
7. Mean time to first re-treatment following the initial combination therapy
8. Mean change in retinal lesion thickness by optical coherence tomography (OCT) at centre of fovea at 3, 6, and 12 months
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Source(s) of Monetary Support
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King's Research Fund (UK), Novartis Pharmaceuticals UK Limited (UK)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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