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

Completed

• Conditions: Choroidal neovascularization (CNV) secondary to Age-related macular degeneration (AMD); Eye Diseases; Macular degeneration

• Registration Number: ISRCTN81615611
• Lead Sponsor: The Newcastle upon Tyne Hospitals NHS Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09-07
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 400

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
1. Change in lesion size at one year<br>2. Number of re-treatments required in one year<br>3. Incidence of serious complications<br>4. Quality of life measures: NEIVFQ(25); SF-36<br>5. Contrast sensitivity threshold (Pelli-Robson contrast sensitivity chart)<br>6. Change in retinal thickness as shown on Ocular coherence tomography