EUCTR2014-000107-27-AT进行中（未招募）1 期
A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-MASKED, SHAM-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF LAMPALIZUMAB ADMINISTERED INTRAVITREALLY TO PATIENTS WITH GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION - Chroma
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 936
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
- •- Willingness and the ability to provide signed informed consent; additionally, at U.S. sites, patients must provide Health Insurance Portability and Accountability Act (HIPAA) authorization, and in other countries, as applicable according to national laws
- •- Participants aged >/= 50 years
- •Ocular Inclusion Criteria: Study Eye
- •- Well demarcated area(s) of GA secondary to AMD with no evidence of prior or active choroidal neovascularization (CNV)
- •- BCVA letter score superior or equal to 49 letters (Snellen equivalent of 20/100 or better) using ETDRS charts at starting distance of 4 m
- •If BCVA letter score is superior or equal to 79 letters (Snellen equivalent
- •of 20/25 or better), at least one GA lesion must be within 250 micrometers of the foveal centre.
- •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 187
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 749
排除标准
- •GA Characteristics Exclusion Criteria
- •- GA in either eye due to causes other than AMD (monogenetic macular dystrophies [e.g., Stargardt disease, cone rod dystrophy] or toxic maculopathies [e.g., chloroquine/hydroxychloroquine maculopathy])
- •Ocular Exclusion Criteria: Study Eye
- •- History of vitrectomy surgery, submacular surgery, or any other surgical intervention for AMD
- •- Previous laser photocoagulation for CNV, diabetic macular edema, retinal vein occlusion, and proliferative diabetic retinopathy
- •- Prior treatment with Visudyne®, external-beam radiation therapy (for intraocular conditions), or transpupillary thermotherapy
- •- History of prophylactic subthreshold laser treatment for AMD
- •- Previous intravitreal drug delivery (e.g., intravitreal corticosteroid injection, anti-angiogenic drugs, anti-complement agents, or device implantation). A single intraoperative administration of a corticosteroid during cataract surgery for cystoid macular edema prophylaxis at least 3 months prior to screening is permitted.
- •Ocular Exclusion Criteria: Non-study eye
- •- Non-functioning non-study eye defined as either:
- •BCVA of hand motion or worse OR no physical presence of non-study eye (i.e., monocular)
- •Ocular Exclusion Criteria: Both Eyes
- •- Previous participation in interventional clinical trials for geographic atrophy or dry AMD (except of vitamins and minerals) irrespective of the route of administration (ocular or systemic)
- •- Previous treatment with eculizumab, lampalizumab, fenretidine or any
- •other drugs for geographic atrophy or dry AMD treatment
- •Concurrent Systemic Conditions Exclusion Criteria
- •- Uncontrolled blood pressure (defined as systolic >180 mm Hg and/or diastolic >110 mm Hg while patient is sitting) If a patient’s initial measurement exceeds these values, a second reading may be taken 30 or more minutes later. If the patient’s blood pressure must be controlled by anti hypertensive medication, the patient can become eligible if medication is taken continuously for at least 30 days prior to Day 1.
- •- History of other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding that gives reasonable suspicion of a disease or condition that contraindicates the use of lampalizumab or that might affect interpretation of the results of the study or that renders the patient at high risk of treatment complications
- •- Treatment for active systemic infection or localized infection. The
- •ongoing prophylactic use of antimicrobial therapy should be discussed with the Medical Monitor.
- •- Predisposition or history of increased risk of infection
- •- Active malignancy within past 12 months except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma and prostate cancer with a Gleason score of < 6 and a stable prostatespecific antigen (PSA) for > 12 months.
- •- History of allergy to fluorescein that is not amenable to treatment
- •- History of a severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the lampalizumab injection
- •- Inability to comply with study or follow-up procedures
- •- Inability to obtain CFP, FAF, and FA of sufficient quality to be analyzed and graded by the central reading center
- •- Previous participation in any studies of investigational drugs within 3 months (except as listed in protocol section 4.1.2d) preceding Day 1 (excluding vitamins and minerals)
研究者
相似试验
进行中（未招募）
1 期
A Study to Evaluate the Efficacy and Safety of Faricimab in Patients with Macular Edema Secondary to Branch Retinal Vein OcclusioMacular edema secondary to Branch Retinal Vein OcclusionMedDRA version: 20.0Level: PTClassification code 10038907Term: Retinal vein occlusionSystem Organ Class: 10015919 - Eye disordersEUCTR2020-000440-63-CZF.Hoffmann La-Roche Ltd570
进行中（未招募）
1 期
A Study Investigating the Efficacy and Safety of Lampalizumab Intravitreal Injections in Patients with Geographic Atrophy Secondary to Age-Related Macular Degeneration (Study #1)EUCTR2014-000107-27-DEF. Hoffmann-La Roche Ltd936
进行中（未招募）
1 期
A Study Investigating the Efficacy and Safety of Lampalizumab Intravitreal Injections in Patients with Geographic Atrophy Secondary to Age-Related Macular Degeneration (Study #2)EUCTR2014-000106-35-SEF. Hoffmann-La Roche Ltd936
进行中（未招募）
1 期
A Study to Evaluate the Efficacy and Safety of Faricimab in Patients with Macular Edema Secondary to Branch Retinal Vein OcclusioEUCTR2020-000440-63-HUF.Hoffmann La-Roche Ltd520
进行中（未招募）
1 期
A Study Investigating the Efficacy and Safety of Lampalizumab Intravitreal Injections in Patients with Geographic Atrophy Secondary to Age-Related Macular Degeneration (Study #2)EUCTR2014-000106-35-HUF. Hoffmann-La Roche Ltd936