RecruitingPhase 4ACTRN12609001051235

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".


Sponsor

Royal Adelaide Hospital

Enrollment

20 participants

Start Date

Sep 10, 2007

Study Type

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

Sex: Both males and femalesMin Age: 50 YearssMax Age: 90 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining two treatments — photodynamic therapy (a light-activated treatment) and ranibizumab injections into the eye — works better than injections alone for people with age-related macular degeneration (AMD). AMD is a condition that damages the central part of the retina and can lead to central vision loss. The hope is that the combination may mean fewer injections are needed over time. You may be eligible if: - You are between 50 and 90 years old - You have been diagnosed with AMD causing abnormal blood vessel growth under the retina - Your best corrected vision in the study eye is between 20/40 and 20/320 - You are eligible for photodynamic therapy (Visudyne) in the study eye You may NOT be eligible if: - You have porphyria or a known allergy to verteporfin (the drug used in photodynamic therapy) - You have a history of liver problems or blocked bile ducts - You are pregnant, breastfeeding, or of childbearing age without using contraception - You have previously had photodynamic therapy, radiation, or certain surgeries on the study eye - You have uncontrolled glaucoma, active eye infection, or other significant eye conditions Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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)

Australia

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ACTRN12609001051235