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).
- Conditions
- AMD (Aged-Related Macular Degeneration)Eye - Diseases / disorders of the eye
- Registration Number
- ACTRN12609001051235
- Lead Sponsor
- Royal Adelaide Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
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.
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method