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| 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 |
| Source of record | UK Trials |
| ISRCTN | ISRCTN33957677 |
| Date ISRCTN assigned | 18/01/2008 |
| Local reference number(s) | 05NB13 |
| Public title | 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 |
| Scientific title | |
| Acronym | N/A |
| Disease/condition/study domain | Macula degeneration |
| 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. |
| Design/methodology | Open-label, randomised, active controlled parallel group trial |
| Research ethics review | Ethics approval received from the King¿s College Hospital Ethics Committee on the 29th January 2007 (ref no. 05NB13). |
| Countries of trial | United Kingdom |
| Participants - 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 |
| Participants - 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 |
| Patient information material | |
| Anticipated start date | 16/01/2006 |
| Anticipated end date | 15/01/2008 |
| Status of trial | Completed |
| Target number of participants | 80 |
| Interventions | 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 |
| Primary outcome measure(s) | The percentage of less than 15 letter loss at one year. |
| Secondary outcome measure(s) | 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 |
| Sources of funding | 1. Novartis Pharmaceuticals UK Limited (UK) 2. King's Research Fund (UK) |
| Sponsor name | King's College Hospital (UK) |
| Sponsor details | Denmark Hill Camberwell London United Kingdom SE5 9RS |
| Sponsor website | http://www.kch.nhs.uk/ |
| Contact name | Mr Victor Chong |
| Contact details | King's College Hospital Denmark Hill Camberwell London United Kingdom SE5 9RS |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN33957677 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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