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| The safety and efficacy of posterior juxta-scleral (40 mg) or intra-vitreal (4 mg) triamcinolone acetonide, in addition to verteporfin photodynamic therapy for choroidal neovascularization (CNV), in age-related macular degeneration (AMD): a randomised controlled trial - STUDY STOPPED |
| Source of record | UK Trials |
| ISRCTN | ISRCTN81615611 |
| Date ISRCTN assigned | 07/09/2005 |
| Local reference number(s) | NRR Pub ID N0503172670 (03428) |
| Public title | The safety and efficacy of posterior juxta-scleral (40 mg) or intra-vitreal (4 mg) triamcinolone acetonide, in addition to verteporfin photodynamic therapy for choroidal neovascularization (CNV), in age-related macular degeneration (AMD): a randomised controlled trial - STUDY STOPPED |
| Scientific title | |
| Acronym | TPDT |
| Disease/condition/study domain | Choroidal neovascularization (CNV) secondary to Age-related macular degeneration (AMD) |
| Study hypothesis | To compare the effectiveness of (a) intra-vitreal and (b) posterior juxta-scleral triamcinolone acetonide as an adjunt to verteporfin photodynamic therapy for CNV secondary to AMD with (c) verteporfin photodynamic therapy alone. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - 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. Predominantly classic CNV on fluorescein angiography 6. Logarithm of the minimum angle of resolution (LogMAR) visual acuity of >35 letters on 2 m Early Treatment Diabetic Retinopathy Study (ETDRS) chart 7. Does not have open angle glaucoma |
| 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 such as unstable angina, dialysis, 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 ≥8 diopters in their current or any previous glasses prescription 5. Signs of other retinal conditions that may have caused the CNV such as angiod streaks, choroidal rupture, 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. Allergic to fluorescein or verteporfin or triamcinolone acetonide 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 utilized 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. <35 letters on the ETDRS logMAR chart 16. Inability to read a logMAR chart 17. Intraocular surgery in study eye within 60 days prior to planned enrolment in study |
| Patient information material | |
| Anticipated start date | 01/10/2005 |
| Anticipated end date | 01/10/2007 |
| Status of trial | Stopped |
| Target number of participants | 400 |
| Interventions | 1. Posterior juxta-scleral (40 mg) triamcinolone acetonide + verteporfin photodynamic therapy 2. Intra-vitreal (4 mg) triamcinolone acetonide + verteporfin photodynamic therapy 3. Verteporfin photodynamic therapy alone |
| Primary outcome measure(s) | Number of patients losing more than 15 letters (3 lines) of visual acuity (ETDRS logMAR chart at 2m) at 1 year. |
| Secondary outcome measure(s) | 1. Change in lesion size at one year 2. Number of re-treatments required in one year 3. Incidence of serious complications 4. Quality of life measures: NEIVFQ(25); SF-36 5. Contrast sensitivity threshold (Pelli-Robson contrast sensitivity chart) 6. Change in retinal thickness as shown on Ocular coherence tomography |
| Sources of funding | Internally funded by participating centres. This study, although a separate randomised controlled trial requiring all the usual approvals, is nested within the UK Verteporfin Photodynamic therapy Cohort study. It will utilise the infrastructure of that study. |
| Sponsor name | The Newcastle upon Tyne Hospitals NHS Trust (UK) |
| Sponsor details | Royal Victoria Infirmary Queen Victoria Rd Newcastle Upon Tyne United Kingdom NE1 4LP |
| Sponsor telephone | +44 (0)191 282 5213 |
| Sponsor email | Craig.MacKerness@trvi.nuth.northy.nhs.uk |
| Contact name | Mr James Talks |
| Contact details | Dept. Ophthalmology Claremont Wing Royal Victoria Infirmary Queen Victoria Rd Newcastle upon Tyne United Kingdom NE1 4LP |
| Contact telephone | +44 (0)191 282 5452 |
| Contact fax | +44 (0)191 282 5446 |
| Contact email | james.talks@nuth.nhs.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN81615611 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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