Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
06NB37
Study information
Scientific title
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
Acronym
ViMDeR (Visudyne, Minocycline, Dexamethasone and Ranubizumab)
Study hypothesis
To assess the safety and effectiveness of the combined therapy of intravitreal ranubizumab/dexamethasone, oral minocycline and verteporfin photodynamic therapy for subfoveal choroidal neovascularisation (CNV) secondary to age-related macular degeneration (AMD).
Ethics approval(s)
Ethics approval received from the King's College Hospital Research Ethics Committee in June 2007.
Study design
Non-randomised, non-controlled pilot trial
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Age-related macular degeneration
Intervention
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.
Intervention type
Drug
Pharmaceutical study type(s)
Phase
Not Specified
Drug/device/biological/vaccine name(s)
Verteporfin, anibizumab, dexamethasone, minocycline
Primary outcome measure
Evaluate the changes in visual acuity from baseline at 12 months in patients treated with intravitreal ranibizumab in combination with verteporfin photodynamic therapy.
Secondary outcome measures
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
Overall study start date
01/06/2007
Overall study end date
01/06/2008
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type(s)
Patient
Age group
Adult
Sex
Both
Target number of participants
20
Participant 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
Recruitment start date
01/06/2007
Recruitment end date
01/06/2008
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
King's College Hospital
London
SE5 9RS
United Kingdom
Sponsor information
Organisation
King's College Hospital NHS Foundation Trust (UK)
Sponsor details
c/o Ernest Choy
Denmark Hill
London
SE5 9RS
England
United Kingdom
Sponsor type
Hospital/treatment centre
Website
ROR
Funders
Funder type
University/education
Funder name
King's Research Fund (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Novartis Pharmaceuticals UK Limited (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results of pilot study | 01/12/2011 | Yes | No |