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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-002466-11-GB

Enrollment

Registered

2005-12-01

Start date

2006-01-03

Completion date

Unknown

Last updated

2012-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Classic or predominantly classic age related macular degeneration

Interventions

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 C

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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. ;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.	—

Measure

Time frame

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. ;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.

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026