EUCTR2004-001453-28-AT进行中（未招募）不适用
Open-label, Multicenter, Phase II Study Assessing the Safety of Lucentis (ranibizumab) Administered in Conjunction with Photodynamic Therapy with Visudyne in Patients with Occult or Predominantly Classic Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration
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
- 30
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
- •Patients 50 years of age or greater
- •Patients with subfoveal choroidal neovascularization lesions secondary to AMD,
- •either predominantly classic or occult with no classic component
- •CNV lesion in the study eye is =5400 microns in greatest linear dimension
- •Patients who have a BCVA score between 73 and 24 letters, inclusively, in the
- •study eye using ETDRS-like grading charts (approximately 20/40 to 20/320)
- •Willing to return for scheduled visits for 4 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
- •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
- •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,
- •subfoveal focal laser photocoagulation, vitrectomy, submacular surgery, or
- •transpupillary thermotherapy
- •Previous or current intravitreal drug delivery (e.g., intravitreal corticosteroid
- •injection or device implantation) in the study eye
- •Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within one
- •month preceding Day 1
- •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 Ethambuto is
- •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 anti-glaucoma mediation).
- •History of submacular surgery or other surgical intervention for AMD in the study
- •eye within two months preceding Day 1
- •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 eyeball adnexa
- •Vitreous hemorrhage or history of rhegmatogenous retinal detachment or macular
- •hole (Stage 3 or 4) in the study eye
研究者
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