EUCTR2006-004172-12-PL进行中（未招募）不适用
A 12-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
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 250
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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