CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 111 enrolled
Drug / intervention
Verteporfin photodynamic therapy +2 moredrug
Likely dose
Verteporfin 6 mg/m² intravenous infusion followed by light activation of 50 J/cm²; Pegaptanib 0.3 mg intravitreal injection; Triamcinolone acetonide 1 mg or 4 mg intravitreal injectionAI-extracted
Key inclusion· 3
  • ✓Age over 50 years
  • ✓All types of untreated subfoveal choroidal neovascularization secondary to AMD
  • ✓Lesion size less than 5400 microns in greatest linear dimension
Key exclusion· 5
  • ✕Prior photodynamic therapy, external beam radiation, subfoveal focal laser photocoagulation, submacular surgery, or transpupillary thermotherapy
  • ✕Known allergy to verteporfin, triamcinolone, or pegaptanib
  • ✕Prior treatment with Macugen or other anti-angiogenic compounds or investigational treatments for neovascular AMD (including Ruboxistaurin, Lucentis, Retaane, squalamine, siRNA, VEGF-Trap)
  • ✕Fibrosis, hemorrhage, pigment epithelial detachments, retinal pigment epithelium tear, or other hypoflourescent lesions obscuring >50% of CNV lesion

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00242580
NCT00242580Phase 3Completed
CompareCT.gov

A 24-month Randomized, Double-masked, Sham Controlled, Multicenter, Phase IIIB Study Comparing Photodynamic Therapy With Verteporfin (Visudyne®) Plus Two Different Dose Regimens of Intravitreal Triamcinolone Acetonide (1 mg and 4 mg) Versus Visudyne® Plus Intravitreal Pegaptanib(Macugen®) in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-related Macular Degeneration

Novartis Pharmaceuticals·interventional·Posted Oct 20, 2005·Updated Mar 31, 2016

In Brief

A Phase 3 clinical trial evaluating Verteporfin photodynamic therapy, Pegaptanib, and 1 other intervention for Macular Degeneration and Choroidal Neovascularization. Completed, enrolled 111 participants across 1 site.

Detailed Summary

To evaluate the safety and efficacy of the combination treatments in wet age-related macular degeneration. The combination treatment consists of verteporfin photodynamic therapy and either triamcinolone acetonide or pegaptanib added as an intravitreal injection.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMacular Degeneration, Choroidal Neovascularization
CountriesUnited States
CollaboratorsQLT Inc.

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 20, 2005
Enrollment StartSep 1, 2005
Primary CompletionJan 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 20.7 years ago

Interventions

Verteporfin photodynamic therapydrug

After a 10-minute intravenous infusion of verteporfin at a dose of 6 mg/m\^2 body surface area, verteporfin was activated by light application of 50 J/cm\^2 to the study eye, begun 15 minutes after the start of infusion.

Pegaptanibdrug

Pegaptanib sodium 0.3 mg administered by intravitreal injection.

Triamcinolone acetonidedrug

Triamcinolone acetonide administered by intravitreal injection.