| Source of record | UK Trials |
| ISRCTN | ISRCTN64352175 |
| Date ISRCTN assigned | 30/09/2005 |
| Local reference number(s) | N0295142266 |
| Public title | The impact of indocyanine green (ICG) angiography in multiple diagnostic imaging for the management of exudative age-related macular degeneration (ARMD): a single blind prospective randomised controlled trial of fluorescein angiography vs FA & ICG |
| Scientific title |
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| Acronym | N/A |
| Disease/condition/study domain | Eye Diseases: Age-related macular degeneration (ARMD) |
| Study hypothesis | Attempt to identify ophthalmic features and positive predictive value for ICG as 'diagnosis and management modifier'. The use of indocyanine gren angiography (ICG) may facilitate the identification of lesions that have been proposed to respond to laser treatment. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 240 patients, of whom 24 are estimated to have retinal angiomatous proliferation (RAP). |
| Participants - exclusion criteria | No specific exclusion criteria |
| Patient information material |
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| Anticipated start date | 24/05/2004 |
| Anticipated end date | 24/05/2006 |
| Status of trial | Completed |
| Target number of participants | 240 |
| Interventions | Prospective randomised controlled trial and pilot study.
Interventions are fluorescein angiography compared with fluorescein angiography and indocyanine green angiography.
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| Primary outcome measure(s) | Primary: Moderate and severe visual loss defined as loss of three lines or 15 letters (doubling of visual angles) and loss of 6 lines or 30 letters respectively, on a log MAR visual acuity chart, at 4,8 and 12 months. Secondary: ICG rates modification of fluorescein based diagnosis and management. Specificity and sensitivity of ophthalmic signs predictive of ICG findings. |
| Secondary outcome measure(s) | See Primary outcome measures |
| Sources of funding | University Hospitals Coventry and Warwickshire NHS Trust
NHS R&D Support Funding |
| Sponsor name | Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK) |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Dr Sergio Pagliarini |
| Contact details | Paybody Eye Unit
Coventry & Warwickshire Hospital
Stoney Stanton Road
Coventry
United Kingdom
CV1 4FH |
| Contact telephone | +44 (0)2476 246704/246533 |
| Contact fax | +44 (0)2476 844119 |
| Contact email | sergio.pagliarini@uhcw.nhs.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN64352175 |
| Date last extracted from ISRCTN register | 17/04/2008 |
