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
Inclusion Criteria7
- Age>50 years,
- Males and females,
- Patients presenting with subretinal neovascular membrane secondary to AMD,
- All lesion types (predominantly classic, minimally classic, occult),
- Lesions of < 5,400 mm in greatest linear dimension,
- Best Corrected Visual Acuity (BCVA) of 20/40 to 20/320 in the study eye,
- Eligible for treatment with Visudyne in the study eye according to the Visudyne prescribing information.
Exclusion Criteria16
- Porphyria or a known hypersensitivity to verteporfin or to any of the excipients,
- Patients with a history of liver impairment or biliary obstruction will be excluded
- Retreatment in therapy assoc. severe vision loss; unstable heart disease, uncontrolled hypertension; pregnancy, lactation, children
- Prior treatment in the study eye with Visudyne, external-beam radiation therapy, subfoveal focal laser photocoagulation, vitrectomy, or transpupillary thermotherapy,
- History of submacular surgery or other surgical intervention for Age Macular Degeneration (AMD) in the study eye, glaucoma filtration surgery, corneal transplant surgery,
- Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within one month preceding baseline,
- Patients with angioid streaks or precursors of choroidal neovascularisation (CNV) in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia,
- Extracapsular extraction of cataract with phacoemulsification within three months preceding Baseline, or a history of post-operative complications within the last 12 months preceding Baseline in the study eye (uveitis, cyclitis, etc.),
- History of uncontrolled glaucoma in the study eye (defined as intraocular pressure = 25 mmHg despite treatment with anti-glaucoma medication),
- Aphakia with absence of the posterior capsule in the study eye,
- Active intraocular inflammation (grade trace or above) in the study eye,
- Any active infection involving ocular adnexa including infectious conjunctivitis, keratitis, scleritis, endophthalmitis, as well as idiopathic or autoimmune-associated uveitis in either eye,
- Vitreous hemorrhage or history of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye,
- Presence of a retinal pigment epithelial tear involving the macula in the study eye, Subfoveal fibrosis or significant atrophy in the study eye
- Women of childbearing potential not using the contraception method(s) specified in this study (specify), as well as women who are breastfeeding
- Known sensitivity to study drug(s) or class of study drug(s)
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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