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.

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2005
INTERVENTION: Trade Name: Kenalog Product Name: Triamcinolone acetonide Pharmaceutical Form: Suspension for injection INN or Proposed INN: Triamcinolone acetonide Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 40‐ Pharmaceutical form of the placebo: Spot‐on* Route of administration of the placebo: Ocular use CONDITION: Classic or predominantly classic age related macular degeneration PRIMARY OUTCOME: 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) 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.; Change in lesion size at one year. ; Number of re‐treatments required in one year.; Incidence of serious complications.; 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.; 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
Epistemonikos ID: 275dedc85cea82a4096fab4e408ff4824220b57b
First added on: Aug 21, 2024