A Phase 2b, Multicenter, Double-masked, Randomized Study Evaluating the Safety and Clinical Response of Subretinal Administration of CNTO 2476 in Subjects With Visual Acuity Impairment Associated With Geographic Atrophy Secondary to Age Related Macular Degeneration
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 21
- 主要终点
- Change From Baseline in Best Corrected Visual Acuity (BCVA) Total Letters Score at Month 1- Treated Eye
研究概览
简要总结
The purpose of this study is to evaluate the safety and performance profile of the suprachoroidal surgical approach and the Delivery System.
详细描述
This is a multicenter (when more than one hospital or medical school team work on a medical research study) study which includes an initial unmasked safety phase. The duration of participation in the study for each participant is approximately 3 years. Efficacy will be evaluated at 6 months, 12 months and annually thereafter. Participants' safety will be monitored throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) confirmed within 45 days prior to initial randomization verified by the central reading center
- •Study eyes will have a best corrected visual acuity (BCVA) of 20/80 to 20/800 [Early Treatment Diabetic Retinopathy Study (ETDRS) log of the minimum angle of resolution (logMAR) value 0.6-1.6]. The treatment eye will be that with the worse BCVA at Screening. If BCVA is clinically equivalent, the eye with the larger GA determines the study eye
- •Participant is a suitable candidate for ophthalmologic surgery, is willing and able to comply with the surgical procedure, scheduled visits, treatment plan, laboratory tests and other study procedures. Participant has met criteria of the surgery center anti-coagulation protocol, if applicable
- •Each participant must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study
排除标准
- •Participant has a history of neovascular ("wet") AMD in the treatment eye, including evidence of retinal pigment epithelium rips or evidence of subretinal or choroidal neovascularization or fluid. In cases where imaging is inconclusive, review of the case with the study site, considering history and imaging will determine eligibility. History or evidence of neovascular AMD in the fellow eye is allowed, if anti-vascular endothelial growth factor (VEGF) therapy has not been required for at least 8 weeks prior to Screening
- •Geographic atrophy secondary to any causes other than AMD in either eye
- •A diagnosis of glaucoma with an intraocular pressure (IOP) greater than or equal to (>=) 25 millimeter of mercury (mmHg) while being treated with an ocular hypotensive drug. Treatment should be no more than 1 drug preparation/combination, which can contain 1 or 2 ocular hypotensive active ingredients; participants receiving more than 2 ocular hypotensive active ingredients are excluded
- •Nuclear sclerotic cataract, cortical spoking, posterior subcapsular cataract above Grade 2 per Age Related Eye Disease Study (AREDS) scale or any other ophthalmologic condition that reduces the clarity of the media that, in the opinion of the investigator or reading center, interferes with ophthalmologic examination (example, corneal abnormalities, inadequate pupillary dilation), surgery or imaging in the study eye
- •Myopia greater than minus (>-) 8 diopters and participants with greater than (>) 4 diopters of astigmatism, and greater than plus (>+) 10 diopters of hyperopia
研究组 & 干预措施
Open-Label Safety Run-in Phase: Treatment Group
Participants will receive CNTO 2476 3.0 x 10^5 cells in 50 microliter (mcL). CNTO 2476 will be delivered using the custom-designed Delivery System.
干预措施: CNTO 2476 3.0 x 10^5 cells (Drug)
Open-Label Safety Run-in Phase: Treatment Group
Participants will receive CNTO 2476 3.0 x 10^5 cells in 50 microliter (mcL). CNTO 2476 will be delivered using the custom-designed Delivery System.
干预措施: Subretinal Delivery System (Device)
结局指标
主要结局
Change From Baseline in Best Corrected Visual Acuity (BCVA) Total Letters Score at Month 1- Treated Eye
时间窗: Baseline and Month 1
Best corrected visual acuity (BCVA) was assessed in the study eye (Treated eye). BCVA measurements were made using the logarithm of the minimum angle of resolution (logMAR) visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.
Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 3- Treated Eye
时间窗: Baseline and Month 3
BCVA was assessed in the study eye (Treated eye). BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.
Change From Baseline in Best Corrected Visual Acuity (BCVA) Total Letters Score at Month 24- Treated Eye
时间窗: Baseline and Month 24
BCVA was assessed in the study eye (Treated eye). BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.
Change From Baseline in Best Corrected Visual Acuity (BCVA) Total Letters Score at Month 36- Treated Eye
时间窗: Baseline and Month 36
BCVA was assessed in the study eye (Treated eye). BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.
Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 24- Fellow Eye
时间窗: Baseline and Month 24
BCVA was assessed in the fellow eye. BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.
Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 30- Fellow Eye
时间窗: Baseline and Month 30
BCVA was assessed in the fellow eye. BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.
Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 36- Fellow Eye
时间窗: Baseline and Month 36
BCVA was assessed in the fellow eye. BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.
Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 12- Treated Eye
时间窗: Baseline and Month 12
BCVA was assessed in the study eye (Treated eye). BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.
Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 18- Treated Eye
时间窗: Baseline and Month 18
BCVA was assessed in the study eye (Treated eye). BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.
Change From Baseline in Best Corrected Visual Acuity (BCVA) Total Letters Score at Month 1- Fellow Eye
时间窗: Baseline and Month 1
BCVA was assessed in the fellow eye. BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.
Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 2- Fellow Eye
时间窗: Baseline and Month 2
BCVA was assessed in the fellow eye. BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.
Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 3- Fellow Eye
时间窗: Baseline and Month 3
BCVA was assessed in the fellow eye. BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.
Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 6- Fellow Eye
时间窗: Baseline and Month 6
BCVA was assessed in the fellow eye. BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.
Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 6- Treated Eye
时间窗: Baseline and Month 6
BCVA was assessed in the study eye (Treated eye). BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.
Change From Baseline in Best Corrected Visual Acuity (BCVA) Total Letters Score at Month 30- Treated Eye
时间窗: Baseline and Month 30
BCVA was assessed in the study eye (Treated eye). BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.
Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 12- Fellow Eye
时间窗: Baseline and Month 12
BCVA was assessed in the fellow eye. BCVA measurements were made using logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there are 5 letters per line, the total score for a line on the logMAR chart represents a change of 0.1 log units. The formula for calculating the logMAR BCVA score is: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.
Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 18- Fellow Eye
时间窗: Baseline and Month 18
BCVA was assessed in the fellow eye. BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.
Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 2- Treated Eye
时间窗: Baseline and Month 2
BCVA was assessed in the study eye (Treated eye). BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02\*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.
次要结局
- Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)(Up to Months 36)
- Number of Participants With Ocular Treatment-emergent Adverse Events(Up to Months 36)
- Percentage of Participants Losing Greater Than or Equal to (>=) 15 Best Corrected Visual Acuity Letters: Treated Eye(Months 1, 2 , 3, 6, 12, 18, 24, 30 and 36)
- Percentage of Participants Losing >=15 Best Corrected Visual Acuity Letters: Fellow Eye(Months 1, 2 , 3, 6, 12, 18, 24, 30 and 36)
- Change From Baseline in Best Corrected Visual Acuity Letters at Months 6 and 12: Treated Eye(Baseline, Months 6 and 12)
- Change From Baseline in Best Corrected Visual Acuity at Months 6 and 12: Fellow Eye(Baseline, Months 6 and 12)
- Change From Baseline in Growth Rate of Geographic Atrophy (GA) Lesion Area at Months 6 and 12: Treated Eye(Baseline, Months 6 and 12)
- Change From Baseline in Growth Rate of Geographic Atrophy Lesion Area at Months 6 and 12: Fellow Eye(Baseline, Months 6 and 12)