A 24-month randomized, double-masked, multicenter, phase II study assessing safety and efficacy of verteporfin (Visudyne®) photodynamic therapy administered in conjunction with Lucentis™ versus Lucentis™ monotherapy in patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration - MONT BLANC
- Conditions
- Subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD)MedDRA version: 8.1Level: LLTClassification code 10060837Term: Choroidal neovascularization
- Registration Number
- EUCTR2006-004172-12-BE
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 250
• Male or female patients of any race 50 years or older
• Primary or recurrent active subfoveal CNV secondary to AMD, including those with predominantly classic, minimally classic or occult lesions with no classic component
• The total area of CNV (including both classic and occult components) encompassed within the lesion must be > 50% of the total lesion area as defined by fluorescein angiography (FA)
• The total lesion are must have the Greatest Linear Dimension (GLD) = 5400 microns (~9 MPS Disc Areas [DA])
• If the lesion is classified as occult with no classic CNV component, the lesion must have evidence of recent disease progression as defined in the study glossary under active lesion”
• BCVA letter score in the study eye between 73-24 (approximately 20/40 to 20/320 Snellen equivalent) using an ETDRS chart measured at 4 meters distance
• Patients who provide written and informed consent according to legal requirements, and who have signed the consent form prior to initiation of any study procedure
• Patients willing and able to comply with all study procedures
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Ocular concomitant conditions/ diseases
• Presence of angioid streaks, presumed ocular histoplasmosis syndrome, pathologic myopia (-8 or more with evidence of posterior segment abnormalities consistent with pathologic myopia), or CNV secondary to causes other than AMD
• Presence of fibrosis, hemorrhage, pigment epithelial detachments, or other hypofluorescent lesions obscuring greater than 50% of the CNV lesion
• Tear (rip) of the retinal pigment epithelium
• Active, or history of, ocular inflammation or infection in the study eye within 30 days prior to Screening
• Uncontrolled glaucoma in the study eye (defined as intraocular pressure, IOP = 25 mmHg despite treatment with two or more topical pharmacological anti-glaucomatous medication)
• Any concurrent ocular condition in the study eye that may result in visual loss during the study
Ocular treatments
• Prior Visudyne®, external-beam radiation, subfoveal focal laser photocoagulation, submacular surgery, or transpupillary thermotherapy in the study eye
• Prior treatment with Macugen®, Lucentis™, Avastin [bevacizumab] or other anti-angiogenic compound or any investigational treatment (e.g. Ruboxistaurin, Retaane [anecortave acetate], squalamine, siRNA, VEGF-Trap etc.) for neovascular AMD in the study eye (treatment of thefellow eye is permitted if administered > 30 days before Screening)
• History of intraocular surgery in the study eye including pars plana vitrectomy, except for uncomplicated cataract surgery more than 60 days prior to screening
• History of YAG laser posterior capsulotomy in the study eye within 30 days prior to screening
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method