A pilot study to examine the safety and efficacy of posterior juxta-scleral (80 mg) triamcinolone acetonide, administration, in addition to Visudyne (verteporfin) photodynamic therapy for predominantly classic choroidal neovascularisation secondary to age-related macular degeneration: an open-label, randomised, active controlled trial

ISRCTN ISRCTN33957677
DOI https://doi.org/10.1186/ISRCTN33957677
Secondary identifying numbers 05NB13
Submission date
04/11/2007
Registration date
18/01/2008
Last edited
15/02/2012
Recruitment status
Stopped
Overall study status
Stopped
Condition category
Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Victor Chong
Scientific

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

Study information

Study designOpen-label, randomised, active controlled parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectivesThe 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(s)Ethics approval received from the King's College Hospital Ethics Committee on the 29th January 2007 (ref no. 05NB13).
Health condition(s) or problem(s) studiedMacula degeneration
InterventionPatients 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Triamcinolone acetonide
Primary outcome measureThe percentage of less than 15 letter loss at one year.
Secondary outcome measures1. 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 study start date16/01/2006
Completion date01/11/2007
Reason abandoned (if study stopped)"Participant recruitment issue"

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants80
Key inclusion criteria1. 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
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
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
Date of first enrolment16/01/2006
Date of final enrolment01/11/2007

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

King's College Hospital
London
SE5 9RS
United Kingdom

Sponsor information

King's College Hospital (UK)
Hospital/treatment centre

Denmark Hill
Camberwell
London
SE5 9RS
England
United Kingdom

Website http://www.kch.nhs.uk/
ROR logo "ROR" https://ror.org/01qz4yx77

Funders

Funder type

Industry

Novartis Pharmaceuticals UK Limited (UK)

No information available

King's Research Fund (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan