Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
05NB13
Study information
Scientific title
Acronym
Study hypothesis
The aim of this study is to assess the effectiveness of posterior juxtascleral triamcinolone in reducing visual loss when used in conjunction with photodynamic therapy, for the treatment ofexudative age related macular degeneration. We will be comparing the effect of the combined treatment against the standard treatment (Photodynamic Therapy [PDT]).The actions of truamcinolone are anti-inflammatory and anti-angiogenic. A beneficial effect of steroids in the eyes of patients with choroidal neovascularisation has been suggested in the literature.
As of 15/02/2012, the anticipated end date of trial was updated from 15/01/2008 to 01/11/2007. The trial was terminated early in November 2007 due to poor recruitment follwing the NICE approval of Lucentis for treatment of neovascular AMD.
Ethics approval
Ethics approval received from the King's College Hospital Ethics Committee on the 29th January 2007 (ref no. 05NB13).
Study design
Open-label, randomised, active controlled parallel group trial
Primary study design
Interventional
Secondary study design
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
Macula degeneration
Intervention
Patients are randomised to one of two treatments:
1. Patients receive Photodynamic Treatment (PDT) on their initial treatment visit. Follow up is every three months for a year with further PDT if required
2. Patients receive PDT and posterior juxtascleral injection of triamcinolone on their initial treatment visit. Follow up is every three months for one year. If required they will receive PDT on follow up visits
Intervention type
Drug
Phase
Not Specified
Drug names
Triamcinolone acetonide
Primary outcome measure
The percentage of less than 15 letter loss at one year.
Secondary outcome measures
1. Percentage of more than 30 letter loss at one year
2. Number of re-treatments required in one year
3. Change in lesion size at one year
Overall trial start date
16/01/2006
Overall trial end date
01/11/2007
Reason abandoned (if study stopped)
"Participant recruitment issue"
Eligibility
Participant inclusion criteria
1. Age 50 years or older, male and female
2. Clinical diagnosis of age-related macular degeneration (AMD)
3. Subfoveal choroidal neovascularisation (CNV) confirmed by fluorescein angiography
4. Best corrected visual acuity of 35 letters on Early Treatment Diabetic Retinopathy Study (ETDRS) chart
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
80
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
3. Patient has a current ophthalmic condition or history of an ophthalmic condition that might compromise the assessment of the treatment
4. Signs of a myopic retina or refraction of greater than -8 dioptres in their current or 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
Recruitment start date
16/01/2006
Recruitment end date
01/11/2007
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 (UK)
Sponsor details
Denmark Hill
Camberwell
London
SE5 9RS
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
Novartis Pharmaceuticals UK Limited (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
King's Research Fund (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
Basic results (scientific)
Publication list