NL-OMON31180尚未招募2 期
A 12-month randomized, double-masked, multicenter, phase II study assessing safety and efficacy of 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
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- ovartis
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Protocol page 17
- •- Male or female patients of any race 50 years or older
- •- Presence of primary active subfoveal CNV secondary to AMD
- •- Total CNV area more than or equal to 50% of the total lesion area
- •- Total lesion area must be less than or equal to 5400 microns
- •- BCVA letter score in study eye between 24 and 73 letters using ETDRS chart at 4 meters distance
- •- Written and informed consent
- •- Patients willing and able to comply with study procedures
排除标准
- •Protocol page 17, 18 and 19
- •- Presence of CNV secondary to causes other than AMD
- •- Presence of hypofluorescent lesions other than CNV greater than 50% of total lesion
- •- Tear of the retinal pigment epithelium
- •- Ocular inflammation or infection within 30 days prior to randomization
- •- Uncontrolled glaucoma
- •- Prior treatment for neovascular AMD
- •- History of intraocular surgery
- •- Hypersensitivity to components of study drugs
- •- Use of medication that could induce photosensitivity
- •- Unable to obtain results from study assessments
研究者
相似试验
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 BLANCSubfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD)MedDRA version: 8.1Level: LLTClassification code 10060837Term: Choroidal neovascularizationEUCTR2006-004172-12-PLovartis Pharma Services AG250
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 BLANCSubfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD)MedDRA version: 8.1Level: LLTClassification code 10060837Term: Choroidal neovascularizationEUCTR2006-004172-12-NLovartis Pharma250
进行中（未招募）
不适用
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 BLANCSubfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD)MedDRA version: 8.1Level: LLTClassification code 10060837Term: Choroidal neovascularizationEUCTR2006-004172-12-DKovartis Pharma AG250
进行中（未招募）
不适用
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 BLANCSubfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD)MedDRA version: 8.1Level: LLTClassification code 10060837Term: Choroidal neovascularizationEUCTR2006-004172-12-HUovartis Pharma AG250
进行中（未招募）
不适用
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 BLANCEUCTR2006-004172-12-BEovartis Pharma Services AG250