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
Protocol serial number 06NB37
Sponsor King's College Hospital NHS Foundation Trust (UK)
Funders King's Research Fund (UK), Novartis Pharmaceuticals UK Limited (UK)
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 of protocol

Not provided at time of registration

Contact information

Mr Victor Chong
Scientific

King's College Hospital
Denmark Hill
London
SE5 9RS
United Kingdom

Study information

Primary study designInterventional
Study designNon-randomised, non-controlled pilot trial
Secondary study designNon randomised controlled trial
Study type Participant information sheet
Scientific titleA 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 acronymViMDeR (Visudyne, Minocycline, Dexamethasone and Ranubizumab)
Study objectivesTo 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.
Health condition(s) or problem(s) studiedAge-related macular degeneration
InterventionPatients 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 typeDrug
PhaseNot Specified
Drug / device / biological / vaccine name(s)Verteporfin, anibizumab, dexamethasone, minocycline
Primary outcome measure(s)

Evaluate the changes in visual acuity from baseline at 12 months in patients treated with intravitreal ranibizumab in combination with verteporfin photodynamic therapy.

Key secondary outcome measure(s)

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

Completion date01/06/2008

Eligibility

Participant type(s)Patient
Age groupAdult
SexAll
Target sample size at registration20
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/06/2007
Date of final enrolment01/06/2008

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

King's College Hospital
London
SE5 9RS
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot 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
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes

Editorial Notes

13/11/2017: Internal review.
27/09/2017: Internal review.

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