Condition category
Eye Diseases
Date applied
28/06/2005
Date assigned
07/09/2005
Last edited
07/09/2007
Prospective/Retrospective
Prospectively 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 James Talks

ORCID ID

Contact details

Dept. Ophthalmology
Claremont Wing
Royal Victoria Infirmary
Queen Victoria Rd
Newcastle upon Tyne
NE1 4LP
United Kingdom
+44 (0)191 282 5452
james.talks@nuth.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NRR Pub ID N0503172670 (03428)

Study information

Scientific title

Acronym

TPDT

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.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Choroidal neovascularization (CNV) secondary to Age-related macular degeneration (AMD)

Intervention

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

Intervention type

Drug

Phase

Not Specified

Drug names

Triamcinolone acetonide

Primary outcome measures

Number of patients losing more than 15 letters (3 lines) of visual acuity (ETDRS logMAR chart at 2m) at 1 year.

Secondary outcome measures

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

Overall trial start date

01/10/2005

Overall trial end date

01/10/2007

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

400

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 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

Recruitment start date

01/10/2005

Recruitment end date

01/10/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Dept. Ophthalmology
Newcastle upon Tyne
NE1 4LP
United Kingdom

Sponsor information

Organisation

The Newcastle upon Tyne Hospitals NHS Trust (UK)

Sponsor details

Royal Victoria Infirmary
Queen Victoria Rd
Newcastle Upon Tyne
NE1 4LP
United Kingdom
+44 (0)191 282 5213
Craig.MacKerness@trvi.nuth.northy.nhs.uk

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

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.

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