Efficacy and safety of verteporfin (Visudyne) in combination with ranibizumab (Lucentis) for the treatment of AMD (Aged-Related Macular Degeneration) (LIV- Lucentis injection with Visudyne).
"Investigator initiated phase IV pilot study trial: Efficacy and safety of verteporfin (Visudyne) in combination with ranibizumab (Lucentis) for the treatment of AMD (Aged-Related Macular Degeneration) (LIV- Lucentis injection with Visudyne) in patients over 50".
Royal Adelaide Hospital
20 participants
Sep 10, 2007
Interventional
Conditions
Summary
Our hypothesis is that with the combination of Photodynamic Therapy (PDT) and Ranibizumab patient would need fewer intravitreal injections. This would be of benefit to the patients in terms of reduced exposure to Ranibizumab as well as importantly a reduced risk of adverse events from the intravitreal injection procedure. In addition, there would be a benefit to the community with a in terms of reduced cost.
Eligibility
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Interventions
Visudyne treatment followed by an intravitreal injection of Lucentis 0.5 mg within 2 hours (visit 1; month 0). Patients will be reviewed again at 6 weeks (visit 2) and 12 weeks (visit 3) at which time repeat intravitreal injections of Lucentis 0.5 mg will be administered. Patients will be followed up again at 6 weekly visits thereafter for a total of 12 months. Visudyne Treatment Visudyne will be administered as an intravenous injection of 6mg/m2 body surface area (BSA) at baseline only a maximum of 2 hours prior to the Lucentis injection. Dosage and Administration Visudyne treatment is a two step process. The first step is a ten minute intravenous infusion of Visudyne at a dose of 6 mg/m2 body surface area, diluted in 30 mL infusion solution. The second step is the light activation of Visudyne 15 minutes after the start of the infusion. For this, a diode laser generating nonthermal red light (wavelength 689 nanometre) is delivered via a slit lamp mounted fibre optic device and a suitable contact lens. At the recommended light intensity of 600 mW/cm2 it takes 83 seconds to deliver the required light dose of 50 J/cm2. The Visudyne and Photodynamic therapy is performed once at the baseline visit.
Locations(1)
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ACTRN12609001051235