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
| ISRCTN | ISRCTN64352175 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN64352175 |
| Protocol serial number | N0295142266 |
| Sponsor | Department of Health |
| Funder | University Hospitals Coventry and Warwickshire NHS Trust (UK), NHS R&D Support Funding |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 07/04/2011
- 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
Dr Sergio Pagliarini
Scientific
Scientific
Paybody Eye Unit
Coventry & Warwickshire Hospital
Stoney Stanton Road
Coventry
CV1 4FH
United Kingdom
| Phone | +44 (0)24 7696 6496 |
|---|---|
| sergio.pagliarini@uhcw.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective randomised controlled trial and pilot study |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Eye Diseases: Age-related macular degeneration (ARMD) |
| Intervention | Interventions are fluorescein angiography compared with fluorescein angiography and indocyanine green angiography. Added 05/09/2008: trial was stopped due to new treataments available. |
| Intervention type | Other |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
1. ICG rates modification of fluorescein based diagnosis and management |
| Completion date | 24/05/2006 |
| Reason abandoned (if study stopped) | New treatments available |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 240 |
| Key inclusion criteria | 240 patients, of whom 24 are estimated to have retinal angiomatous proliferation (RAP). |
| Key exclusion criteria | No specific exclusion criteria |
| Date of first enrolment | 24/05/2004 |
| Date of final enrolment | 24/05/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Paybody Eye Unit
Coventry
CV1 4FH
United Kingdom
CV1 4FH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
