A 12-month randomized, double -masked, controlled, 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 - ND

• Conditions: eovascular wet age-related macular degeneration AMD; MedDRA version: 6.1Level: HLTClassification code 10038896

• Registration Number: EUCTR2006-004172-12-IT
• Lead Sponsor: OVARTIS FARMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02-14
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

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 8804; 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

Exclusion Criteria

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 8805; 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 the fellow 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