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
Scientific
King's College Hospital
Denmark Hill
Camberwell
London
SE5 9RS
United Kingdom
Study information
| Study design | Open-label, randomised, active controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study objectives | 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(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) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 study start date | 16/01/2006 |
| Completion date | 01/11/2007 |
| Reason abandoned (if study stopped) | "Participant recruitment issue" |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 80 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 16/01/2006 |
| Date of final enrolment | 01/11/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
King's College Hospital
London
SE5 9RS
United Kingdom
SE5 9RS
United Kingdom
Sponsor information
King's College Hospital (UK)
Hospital/treatment centre
Hospital/treatment centre
Denmark Hill
Camberwell
London
SE5 9RS
England
United Kingdom
| Website | http://www.kch.nhs.uk/ |
|---|---|
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
