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A pilot study to examine the safety and efficacy of posterior juxta-scleral (80 mg) triamcinolone acetonide, administration, in addition to Visudyne (verteporfin) photodynamic therapy for predominantly classic choroidal neovascularisation secondary to age-related macular degeneration: an open-label, randomised, active controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN33957677
Enrollment
80
Registered
2008-01-18
Start date
2006-01-16
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Macula degeneration Eye Diseases Macula degeneration

Interventions

Patients are randomised to one of two treatments: 1. Patients receive Photodynamic Treatment (PDT) on their initial treatment visit. Follow up is every three months for a year with further PDT if requ

Sponsors

King's College Hospital (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age 50 years or older, male and female 2. Clinical diagnosis of age-related macular degeneration (AMD) 3. Subfoveal choroidal neovascularisation (CNV) confirmed by fluorescein angiography 4. Best corrected visual acuity of 35 letters on Early Treatment Diabetic Retinopathy Study (ETDRS) chart

Exclusion criteria

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 3. Patient has a current ophthalmic condition or history of an ophthalmic condition that might compromise the assessment of the treatment 4. Signs of a myopic retina or refraction of greater than -8 dioptres in their current or previous glasses prescription 5. Signs of other retinal conditions that may have caused the CNV such as angioid streaks, choroidal rupture, and 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

Design outcomes

Primary

MeasureTime frame
The percentage of less than 15 letter loss at one year.

Secondary

MeasureTime frame
1. Percentage of more than 30 letter loss at one year 2. Number of re-treatments required in one year 3. Change in lesion size at one year

Countries

United Kingdom

Outcome results

None listed

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