The safety and efficacy of posterior juxta-scleral (40 mg) or intra-vitreal (4 mg) triamcinolone acetonide, in addition to verteporfin photodynamic therapy for choroidal neovascularization (CNV), in age-related macular degeneration (AMD): a randomised controlled trial - STUDY STOPPED

ISRCTN	ISRCTN81615611
DOI	https://doi.org/10.1186/ISRCTN81615611
Protocol serial number	NRR Pub ID N0503172670 (03428)
Sponsor	The Newcastle upon Tyne Hospitals NHS Trust (UK)
Funder	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.

Submission date: 28/06/2005
Registration date: 07/09/2005
Last edited: 07/09/2007

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

Mr James Talks
Scientific

Dept. Ophthalmology
Claremont Wing
Royal Victoria Infirmary
Queen Victoria Rd
Newcastle upon Tyne
NE1 4LP
United Kingdom

Phone	+44 (0)191 282 5452
Email	james.talks@nuth.nhs.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	TPDT
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Triamcinolone acetonide
Primary outcome measure(s)	Number of patients losing more than 15 letters (3 lines) of visual acuity (ETDRS logMAR chart at 2m) at 1 year.
Key secondary outcome measure(s)	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
Completion date	01/10/2007

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	400
Key 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
Key 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
Date of first enrolment	01/10/2005
Date of final enrolment	01/10/2007

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Dept. Ophthalmology

Newcastle upon Tyne
NE1 4LP
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