NCT01570608已完成3 期
Comparison of Ranibizumab (Lucentis) Monotherapy Versus Combination of Ranibizumab (Lucentis) With Photodynamic Therapy (Verteporfin) in Patients With Subfoveal Choroidal Neovascularisation Due to Age-Related Macular Degeneration - a Pilot Study
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery3 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2007年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 3
- 主要终点
- number of injections
研究概览
简要总结
Ranibizumab has been proven to be effective in large multicentre studies. However, the injections have to be repeated monthly. A combined therapy with the established photodynamic therapy might even be more effective, less intravitreal injections might be necessary due to a synergistic effect.
The study will be conducted to explore whether intravitreal ranibizumab in monotherapy or in combination with verteporfin photodynamic therapy under a new time regime is an effective, safe and convenient treatment for patients with subfoveal Choroidal Neovascularisation (CNV) secondary to Age-Related Macular Degeneration (AMD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BCVA letter score in the study eye between 73-24 (approximately 20/40 to 20/320) using an ETDRS chart measured at 4 meters or Snellen equivalent
- •CNV lesion of any type in the study eye which meets all the following characteristics as determined by fluorescein angiography:
- •Evidence that CNV extends under the geometric center of the foveal avascular zone.
- •The area of the CNV must occupy at least 50% of the total lesion.
- •The lesion must be ≤ 5400 microns in greatest linear dimension (GLD)
- •For occult with no classic CNV, additionally recent disease progression as assessed by the Investigator is required defined as having at least one of the following criteria:
- •Blood associated with the lesion at baseline
- •Loss of VA in the previous 3 months defined as either ≥ 5 letters (ETDRS equivalent) as determined by protocol refraction and protocol measurements, or 2 or more lines using a Snellen or equivalent chart by standard examinations. ≥ 10% increase in the greatest diameter of the lesion in the previous 3 months as assessed by fluorescein angiography
- •Willing to return for scheduled visits for a 12 month period
- •Only one eye will be assessed in the study. If both eyes are eligible, the one with the worse visual acuity will be selected for treatment and study unless, based on medical reasons, the investigator deems the other eye the more appropriate candidate for treatment and study
排除标准
- •Patients who have a BCVA of < 33 letters (approximately 20/200) in both eyes
- •Prior treatment in the study eye with verteporfin, external-beam radiation therapy, vitrectomy, submacular surgery, other surgical intervention for AMD, or transpupillary thermotherapy
- •Previous or current intravitreal drug delivery (e.g., intravitreal corticosteroid injection or device implantation) in the study eye
- •Focal laser photocoagulation (juxta-, extra- or subfoveal) in the study eye
- •Concomitant use of chronic NSAIDs or steroids (by any route) for the duration of study participation (chronic use is defined as multiple doses taken daily for three or more consecutive days at any time during the study). Note that ASA (aspirin) taken as "low dose" up to 100 mg qd for prophylaxis of MI and/or stroke is permitted during study
- •Current use or of likely need for systemic medications known to be toxic to the lens, retina or optic nerve, including Deferoxamine, Chloroquine/ hydroxychloroquine (Plaquenil), Tamoxifen, Phenothiazines and Ethambutol is excluded
- •History of glaucoma filtration surgery, corneal transplant surgery or extracapsular extraction of cataract with phacoemulsification within six months preceding Day One, or a history of post-operative complications within the last 12 months preceding Day One in the study eye (uveitis, cyclitis etc.)
- •History of uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmHg despite treatment with topical anti-glaucomatous mediation).
- •Aphakia or absence of the posterior capsule in the study eye
- •Previous violation of the posterior capsule in the study eye is also excluded unless it occurred as a result of YAG posterior capsulotomy in association with prior, posterior chamber intraocular lens implantation
- •Spherical equivalent of the refractive error in the study eye demonstrating more than -8 diopters of myopia
- •Presence of a retinal pigment epithelial tear involving the macula in the study eye
- •Angioid streaks or precursors of CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia
- •Active intraocular inflammation (grade trace or above) in the study eye
- •Any active infection involving an eyeball adnexa
- •Vitreous hemorrhage or history of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye
研究组 & 干预措施
monotherapy arm
Active Comparator
patients receiving 3 initial Ranibizumab injections, thereafter as needed
干预措施: Ranibizumab (Drug)
combined treatment arm
Active Comparator
干预措施: Ranibizumab (Drug)
combined treatment arm
Active Comparator
干预措施: Verteporfin (Drug)
结局指标
主要结局
number of injections
时间窗: baseline-month 12
Comparision of the number of required retreatments between the groups
次要结局
- number of AE, SAE(12 months)
- central retinal thickness(baseline-month 12)
- distance acuity(baseline-month 12)
研究者
研究点 (3)
Loading locations...
相似试验
Unknown
4 期
Efficacy of Ranibizumab in Combination With Photodynamic Therapy for Wet Age-Related Macular DegenerationVisual AcuityMacular DegenerationNCT00813891McGill University Health Centre/Research Institute of the McGill University Health Centre180
进行中（未招募）
不适用
Comparision of Ranibizumab (Lucentis) Monotherapy versus Combination of Ranibizumab (Lucentis) with Photodynamic Therapy (Verteporfin) in Patients with Subfoveal Choroidal Neovascularisation due to Age-Related Macular Degeneration - KAV-RanibizumabEUCTR2006-006760-28-ATudwig Boltzmann Institut für Retinologie und biomikroskopische Laserchirurgie45
已完成
4 期
Visual Outcome in Patients With Symptomatic Macular Polypoidal Choroidal Vasculopathy (PCV) Treated With Either Ranibizumab as Monotherapy or Combined With Verteporfin Photodynamic Therapy (vPDT)Polypoidal Choroidal VasculopathyAge-related Macular DegenerationNCT01846273Novartis Pharmaceuticals321
已完成
3 期
Efficacy and Safety of Ranibizumab (Intravitreal Injections) in Patients With Visual Impairment Due to Diabetic Macular EdemaDiabetic Macular EdemaNCT00989989Novartis396
进行中（未招募）
1 期
The use of Ranibizumab (Lucentis ®) for the treatment of corneal neovascularisation - Management and control of corneal neovascularisation using LucentisCorneal neovesselsEUCTR2010-018673-37-GBniversity of Nottingham6