Condition category
Eye Diseases
Date applied
20/11/2007
Date assigned
30/05/2008
Last edited
27/03/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Victor Chong

ORCID ID

Contact details

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

Additional identifiers

EudraCT 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

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

Trial setting

Hospitals

Trial 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

Phase

Not Specified

Drug names

Verteporfin, anibizumab, dexamethasone, minocycline

Primary outcome measures

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

01/06/2007

Overall trial end date

01/06/2008

Reason abandoned

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

Patient

Age group

Adult

Gender

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

United Kingdom

Trial 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
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.kch.nhs.uk/

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2011 pilot study in http://www.ncbi.nlm.nih.gov/pubmed/21293163

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