EUCTR2018-002930-19-PL进行中（未招募）1 期
A Phase III Double-Blind, Parallel Group, Multicenter Study to Compare the Efficacy and Safety of Xlucane versus Lucentis® in Patients with Neovascular Age-Related Macular Degeneration - Xplore
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 580
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
- •1. Written and signed informed consent form obtained at Screening before any study related procedures are performed. Patients must be capable of providing their own consent (an impartial witness must be present in case of illiterate patients).
- •2. Willingness and ability to undertake all scheduled visits and assessments as judged by the investigator.
- •3. Newly diagnosed, active subfoveal choroidal neovascularization (CNV) lesion secondary to age-related macular degeneration (AMD) in the study eye. Note: active CNV indicates the presence of leakage as evidenced by fluorescein angiography (FA) and intra- or subretinal fluid as evidenced by optical coherence tomography (OCT), which must be confirmed by the central reading center during Screening:
- •a. The area of CNV must be = 50% of the total lesion area in the study eye, and
- •b. Total lesion area = 9.0 disc areas (DA) in size (including blood, scars, and neovascularization) as assessed by FA in the study eye
- •4. BCVA of = 73 and = 49 ETDRS letter score in the study eye using the ETDRS chart (20/40 to 20/100 Snellen equivalent) at Screening.
- •5. Fellow eye should not be expected to need any anti-VEGF treatment for the duration of study participation based on Investigator´s decision.
- •6. Age = 50 years at Screening.
- •7. Male and female subjects of childbearing potential must be willing to completely abstain or agree to use an appropriate method of contraception from the time of signing the informed consent form and for the duration of study participation through 3 months after the last dose of study drug.
- •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 180
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 400
排除标准
- •1. Any previous intervention, including pharmacological treatment, laser, and/or surgery for wAMD in either eye; (Exception: Vitamin supplementation for AMD prevention). For complete exclusion criteria please see the Study Protocol Amendment 3
- •2. Any previous vitreoretinal surgery in the study eye for any cause.
- •3. Any previous IVT treatment, including any anti-VEGF medications, steroids, and/or any other investigational medication in either eye.
- •4. The use of long-acting steroids, either systemic or intraocular in any eye, in the 18 months before planned initiation of study treatment. (Note: Current or planned Iluvien® [fluocinolone acetonide intravitreal], implantation during the study is prohibited.)
- •5. Subfoveal fibrosis, subfoveal atrophy, and/or scarring extending > 50% of total lesion area in the study eye as assessed by the investigator at Screening and confirmed by the central reading center prior to Randomization.
- •6. Choroidal neovascularization in either eye due to non-AMD causes (eg, DME, RVO, ocular histoplasmosis, trauma) as assessed by FA and confirmed by central reading center. For complete exclusion criteria please see the Study Protocol Amendment 3
- •7. Active or recent (within 28 days prior to Randomization) intraocular, extraocular, and periocular inflammation or infection in either eye.
- •8. History of idiopathic or autoimmune-associated uveitis in either eye.
- •9. Infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye.
- •10. Unmedicated intraocular pressure (IOP) = 30 mm Hg at Screening in either eye.
- •11. Topical ocular corticosteroids administered for = 30 consecutive days in the study eye within 90 days prior to Screening.
- •12. Spherical equivalent of the refractive error in the study eye demonstrating more than 8 diopters of myopia.
- •13. Corneal transplant or corneal dystrophy in the study eye.
- •14. History of rhegmatogenous retinal detachment in the study eye.
- •15. History of macular hole in the study eye.
- •16. Retinal pigment epithelial tear or rip involving the macula in the study eye as assessed by FA and confirmed by the central reading center.
- •17. Current vitreous hemorrhage in the study eye.
- •18. Subretinal hemorrhage that is = 50% of the total lesion area in the study eye, or if the subretinal hemorrhage involves the fovea is 1 or more DA (= 2.54 mm2) in size in the study eye, as assessed by FA and confirmed by the central reading center.
- •19. Other intraocular surgery (including cataract surgery) in the study eye within the 3 months prior to Baseline. The yttrium aluminum garnet [YAG] posterior
- •capsulotomy is allowed no later than 4 weeks prior to Screening.
- •20. Any concurrent intraocular condition in the study eye (eg, cataract or diabetic retinopathy) that, in the opinion of the investigator, could require treatment during the study period to prevent or treat loss of visual acuity.
- •21. Significant media opacities (including cataract) in the study eye interfering with BCVA assessment or fundus imaging (FA/FP/OCT).
- •22. Aphakia or absence of the posterior capsule in the study eye, unless it occurred as a result of a YAG posterior capsulotomy in association with prior posterior chamber intraocular lens (IOL) implantation.
- •23. Presence of advanced glaucoma or optic neuropathy that involves or threatens the central visual field in the study eye (as judged by the investigator).
- •24. History of glaucoma filtering surgery or ALT in the study eye (Exception: Laser iridotomy a
研究者
相似试验
进行中（未招募）
1 期
A Phase III Double-Blind, Parallel Group, Multicenter Study to Compare the Efficacy and Safety of Xlucane versus Lucentis® in Patients with Neovascular Age-Related Macular Degeneration - XploreWet Age-related macular degeneration (AMD)MedDRA version: 20.0Level: PTClassification code 10071129Term: Neovascular age-related macular degenerationSystem Organ Class: 10015919 - Eye disordersEUCTR2018-002930-19-CZXbrane Biopharma580
进行中（未招募）
1 期
A study to determine the effectiveness and safety of the study drug Xlucane compared to Lucentis® in people with the wet form of age-related macular degeneration (wAMD). (The active ingredient in both Xlucane and Lucentis® is ranibizumab. Neither you nor the study doctors will know which treatment you receive).EUCTR2018-002930-19-ROXbrane Biopharma580
进行中（未招募）
1 期
A study to determine the effectiveness and safety of the study drug Xlucane compared to Lucentis® in people with the wet form of age-related macular degeneration (wAMD). (The active ingredient in both Xlucane and Lucentis® is ranibizumab. Neither you nor the study doctors will know which treatment you receive).Wet Age-related macular degeneration (AMD)MedDRA version: 20.0Level: PTClassification code 10071129Term: Neovascular age-related macular degenerationSystem Organ Class: 10015919 - Eye disordersEUCTR2018-002930-19-LTXbrane Biopharma580
进行中（未招募）
1 期
A study to determine the effectiveness and safety of the study drug Xlucane compared to Lucentis® in people with the wet form of age-related macular degeneration (wAMD). (The active ingredient in both Xlucane and Lucentis® is ranibizumab. Neither you nor the study doctors will know which treatment you receive).Wet Age-related macular degeneration (AMD)MedDRA version: 20.0 Level: PT Classification code 10071129 Term: Neovascular age-related macular degeneration System Organ Class: 10015919 - Eye disordersEUCTR2018-002930-19-ESXbrane Biopharma580
进行中（未招募）
1 期
A study to determine the effectiveness and safety of the study drug Xlucane compared to Lucentis® in people with the wet form of age-related macular degeneration (wAMD). (The active ingredient in both Xlucane and Lucentis® is ranibizumab. Neither you nor the study doctors will know which treatment you receive).Wet Age-related macular degeneration (AMD)MedDRA version: 20.0Level: PTClassification code 10071129Term: Neovascular age-related macular degenerationSystem Organ Class: 10015919 - Eye disordersEUCTR2018-002930-19-BGXbrane Biopharma580