NL-OMON47226已完成3 期
A Two-Year, Randomized, Double-Masked, Multicenter, Two-Arm Study Comparing the Efficacy and Safety of RTH258 6 mg Versus Aflibercept in Subjects with Neovascular Age-Related Macular Degeneration. - Efficacy and Safety of RTH258 versus Aflibercept
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- ovartis
- 入组人数
- 9
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Subjects must give written informed consent before any study related procedures are performed
- •2. Subjects must be 50 years of age or older at Screening
- •3. Active CNV lesions secondary to AMD that affect the central subfield (including retinal angiomatous proliferation [RAP] lesions with a CNV component) in the study eye at Screening and confirmed by the Central Reading Center (CRC)
- •4. Total area of CNV (including both classic and occult components) must comprise > 50% of the total lesion area in the study eye at Screening and confirmed by the CRC
- •5. Intra and/or subretinal fluid affecting the central subfield of the study eye at Screening and confirmed by the CRC
- •6. BCVA between 78 and 23 letters, inclusive, in the study eye at Baseline using Early Treatment Diabetic Retinopathy Study (ETDRS) testing
排除标准
- •1. Any active intraocular or periocular infection or active intraocular inflammation (eg, infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis) in either eye at Baseline
- •2. Central subfield of the study eye affected by fibrosis or geographic atrophy assessed by color
- •fundus photography at Screening and confirmed by the CRC
- •3. Total area of fibrosis >= 50% of the total lesion in the study eye at Screening and confirmed by the CRC
- •4. Subretinal blood affecting the foveal center point and/or >= 50% of the lesion of the study eye at Screening and confirmed by the CRC
- •5. Subject has received any approved or investigational treatment for neovascular AMD (other than vitamin supplements) in the study eye at any time
- •6. Any history or evidence of a concurrent intraocular condition in the study eye, including retinal diseases other than neovascular AMD, that, in the judgment of the Investigator, could require medical or surgical intervention during the course of the study to prevent or treat visual loss that might result from that condition, or that limits the potential to gain visual acuity upon treatment with the investigational product.
- •7. Retinal pigment epithelium (RPE) rip/tear in the study eye at Screening
- •8. Current vitreous hemorrhage or history of vitreous hemorrhage in the study eye within 4 weeks prior to Baseline
- •9. History or evidence of the following in the study eye:
- •intraocular or refractive surgery within the 90 day period prior to Baseline
- •previous penetrating keratoplasty or vitrectomy
- •previous panretinal photocoagulation
- •previous submacular surgery, other surgical intervention or laser treatment for AMD
- •10. Uncontrolled glaucoma in the study eye defined as intraocular pressure (IOP) > 25 mmHg on medication or according to Investigator*s judgment at Screening
- •11. Aphakia and/or absence of the posterior capsule in the study eye at Screening
- •12. Intra- or periocular use of corticosteroids in the study eye during the 6 month period prior to
- •13. Use of topical ocular corticosteroids in the study eye for 60 or more consecutive days within
- •the 90 day period prior to Baseline
- •14. Use of systemic corticosteroids for 30 or more consecutive days within the 90 days prior to
- •Baseline, with the exception of low stable doses of corticosteroids (defined as <= 10 mg prednisolone or equivalent dose used for 90 days or more prior to Baseline). Inhaled, nasal or dermal steroids are also permitted
- •15. Previous therapeutic radiation near the region of the study eye
- •16. Treatment with aflibercept (EYLEA®), bevacizumab (AVASTIN®) or pegaptanib (MACUGEN®) within the 4 week period prior to Baseline, or with Ranibizumab, 0.5 mg (LUCENTIS®) within the 2 week period prior to Baseline in the nonstudy eye
- •17. History of a medical condition (disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding) that, in the judgment of the Investigator, would preclude scheduled study visits, completion of the study, or a safe administration of investigational product
- •18. History of hypersensitivity to any component of the test article, control article, or clinically
- •relevant sensitivity to fluorescein dye, as assessed by the Investigator
- •19. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after
- •conception and until the terminat
研究者
相似试验
已完成
2 期
A Phase 2, Multi-Center, Double-Blind, Randomized, Dose-Ranging, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability Of CK-2127107 In Patients with Amyotrophic Lateral Sclerosis (ALS)Motor Neuron DiseaseAmyotrophic Lateral Sclerosism (ALS)10029317NL-OMON45879Cytokinetics, Inc.11
已完成
2 期
A Phase 2, Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study of MGL-3196 in Patients With Heterozygous Familial HypercholesterolemiaHeterozygous Familial HypercholesterolemiaNL-OMON45499Madrigal Pharmaceuticals, Inc.24
已完成
2 期
A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects with Moderate to Severe Ulcerative Colitisinflamatory bowel disease10017969Ulcerative colitisNL-OMON46940Eli Lilly and Company7
已完成
4 期
A randomized, multicentre, double-blind, parallel, sham-controlled study of the gammaCore®, a non-invasive neurostimulator device for the acute relief of episodic and chronic cluster headache.cluster headaches10019231NL-OMON40599electroCore LLC35
已完成
2 期
A Phase 2b Multicentre, Randomised, Double-Blind, Active Controlled, Parallel Group Dose-Ranging Study to Assess the Efficacy, Safety and Tolerability of Zibotentan and Dapagliflozin in Patients with Chronic Kidney Disease with Estimated Glomerular Filtration Rate (eGFR) Between 20 and 60 mL/min/1.73 m2Chronic Kidney DiseaseNL-OMON52170Astra Zeneca9