Condition category
Eye Diseases
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Mr Victor Chong


Contact details

King's College Hospital
Denmark Hill
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


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


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

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


Secondary study design

Non randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Age-related macular degeneration


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



Not Specified

Drug names

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 trial start date


Overall trial end date


Reason abandoned (if study stopped)


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


Age group




Target number of participants


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


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

King's College Hospital
United Kingdom

Sponsor information


King's College Hospital NHS Foundation Trust (UK)

Sponsor details

c/o Ernest Choy
Denmark Hill
United Kingdom

Sponsor type

Hospital/treatment centre



Funder type


Funder name

King's Research Fund (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name

Novartis Pharmaceuticals UK Limited (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

1. 2011 results of pilot study in

Publication citations

  1. Pilot study

    Sivaprasad S, Patra S, DaCosta J, Adewoyin T, Shona O, Pearce E, Chong NV, A pilot study on the combination treatment of reduced-fluence photodynamic therapy, intravitreal ranibizumab, intravitreal dexamethasone and oral minocycline for neovascular age-related macular degeneration., Ophthalmologica, 2011, 225, 4, 200-206, doi: 10.1159/000322363.

Additional files

Editorial Notes

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