Condition category
Eye Diseases
Date applied
04/11/2007
Date assigned
18/01/2008
Last edited
15/02/2012
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

Mr Victor Chong

ORCID ID

Contact details

King's College Hospital
Denmark Hill
Camberwell
London
SE5 9RS
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

05NB13

Study information

Scientific title

Acronym

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.

As of 15/02/2012, the anticipated end date of trial was updated from 15/01/2008 to 01/11/2007. The trial was terminated early in November 2007 due to poor recruitment follwing the NICE approval of Lucentis for treatment of neovascular AMD.

Ethics approval

Ethics approval received from the King's College Hospital Ethics Committee on the 29th January 2007 (ref no. 05NB13).

Study design

Open-label, randomised, active controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Macula degeneration

Intervention

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

Intervention type

Drug

Phase

Not Specified

Drug names

Triamcinolone acetonide

Primary outcome measures

The percentage of less than 15 letter loss at one year.

Secondary outcome measures

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

Overall trial start date

16/01/2006

Overall trial end date

01/11/2007

Reason abandoned

"Participant recruitment issue"

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

80

Participant 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

Recruitment start date

16/01/2006

Recruitment end date

01/11/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

King's College Hospital
London
SE5 9RS
United Kingdom

Sponsor information

Organisation

King's College Hospital (UK)

Sponsor details

Denmark Hill
Camberwell
London
SE5 9RS
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.kch.nhs.uk/

Funders

Funder type

Industry

Funder name

Novartis Pharmaceuticals UK Limited (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

King's Research Fund (UK)

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