Combination therapy of Visudyne, Minocycline, Dexamethasone and Ranibizumab (VIMDER) for the treatment of subfoveal choroidal neovascularisation (CNV)
| ISRCTN | ISRCTN34410935 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN34410935 |
| Secondary identifying numbers | 06NB37 |
- Submission date
- 20/11/2007
- Registration date
- 30/05/2008
- Last edited
- 13/11/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Mr Victor Chong
Scientific
Scientific
King's College Hospital
Denmark Hill
London
SE5 9RS
United Kingdom
Study information
| 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 |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study 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. |
| 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 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 20 |
| 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 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
SE5 9RS
United Kingdom
Sponsor information
King's College Hospital NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
c/o Ernest Choy
Denmark Hill
London
SE5 9RS
England
United Kingdom
| Website | http://www.kch.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/01n0k5m85 |
Funders
Funder type
University/education
King's Research Fund (UK)
No information available
Novartis Pharmaceuticals UK Limited (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results of pilot study | 01/12/2011 | Yes | No |
Editorial Notes
13/11/2017: Internal review.
27/09/2017: Internal review.
