Condition category
Eye Diseases
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
07/04/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Sergio Pagliarini

ORCID ID

Contact details

Paybody Eye Unit
Coventry & Warwickshire Hospital
Stoney Stanton Road
Coventry
CV1 4FH
United Kingdom
+44 (0)24 7696 6496
sergio.pagliarini@uhcw.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0295142266

Study information

Scientific title

Acronym

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.

Ethics approval

Not provided at time of registration

Study design

Prospective randomised controlled trial and pilot study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 outcome measures

1. ICG rates modification of fluorescein based diagnosis and management
2. Specificity and sensitivity of ophthalmic signs predictive of ICG findings

Overall trial start date

24/05/2004

Overall trial end date

24/05/2006

Reason abandoned

New treatments available

Eligibility

Participant inclusion criteria

240 patients, of whom 24 are estimated to have retinal angiomatous proliferation (RAP).

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

240

Participant exclusion criteria

No specific exclusion criteria

Recruitment start date

24/05/2004

Recruitment end date

24/05/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Paybody Eye Unit
Coventry
CV1 4FH
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

University Hospitals Coventry and Warwickshire NHS Trust (UK), NHS R&D Support Funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes