A Pilot Study to Examine the Safety and Efficacy of Posterior Juxtascleral Triamcinolone acetonide administration, in addition to Visudyne photoynamic therapy for predominantly Classic Choroidal Neovascularisation secondary to age related Macular degeneration: an open label randomised active controlled trial. - Efficacy of Juxtascleral Triamcinolone acetonide as an adjunct to PDT
- Conditions
- Classic or predominantly classic age related macular degeneration
- Registration Number
- EUCTR2005-002466-11-GB
- Lead Sponsor
- King's College Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
Patients age 50 years or above with a clinical diagnosis of wet AMD,confirmed to be predominantly classic on fluorescein angiography.
Visual acuity must be 6/60 or better.
Able to give informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Medical conditions that are likely to interfere with scheduled study visits.
Other ophthalmic conditions that may interfere with the assessment of treatment.
Glaucoma
High degree of short sightedness.
Previous photodynamic therapy or other treatment for CNV,such as argon laser.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the effectiveness of posterior juxtascleral (80mg) triamcinolone acetonide as an adjunct to verteporfin photodynamic therapy (PDT) for predominantly classic choroidal neovascularisation (PC CNV) secondary to age-related macular degeneration (AMD);Secondary Objective: Comparison of the treatment effect of the combination therapy (PDT and triamcinolone acetonide) to the effect of the current gold standard of PDT in the treatment of predominantly classic choroidal neovascularization.<br>;Primary end point(s): Mean difference in number of letters lost from baseline of visual acuity (ETDRS log MAR chart at 2m) at 1 year, between groups.<br>Change in lesion size at one year. <br>Number of re-treatments required in one year.<br>Incidence of serious complications.<br>
- Secondary Outcome Measures
Name Time Method