A Phase 1 Safety And Effectiveness Study of Intravitreal Injection of SeeQ CdSe 655 Alt Nanoparticles for Patients With Degenerative Retinal Diseases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Best Corrected Visual Acuity "BCVA"
研究概览
简要总结
This study was a prospective, open label feasibility study conducted at a single clinical site (APEC, Mexico City) to evaluate the safety and preliminary effectiveness of the SeeQ device, with each patient's serving as his/her own contralateral control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects, 21 years of age or older.
- •Subjects with a history of degenerative retinal diseases such as RP.
- •Subjects with a documented history of disease progression.
- •Willing and able to return for all study visits.
- •Willing and able to provide written informed consent for the Clinical Study.
- •Subjects with a BCVA greater or equal to 20/16000 must have consistent fixation demonstrated by indirect ophthalmoscopy with a small circle of light and by consistent location of remaining central visual field detected by VFA.
- •Study Arm A: The best corrected visual acuity must be between 20/16000 and HM as tested by ETDRS chart and ERG B wave amplitude.
- •Study Arm B: The best-corrected visual acuity must be between 20/60 and 20/16000 and visual field of central 15 degrees (III static 30-2 protocol, 31.5 ASB background) greater than 10 dB loss, as determined by a Humphrey Instruments, Inc. Visual Field Analyzer (VFA).
排除标准
- •Subjects with significant lens or corneal pathology (either history of or current) in the study eye other than retinal diseases.
- •Subjects with high myopia in the study eye (axial length greater than or equal to 26.0 millimeters by ultrasound or spherical equivalent at the spectacle plane greater than -8.0 diopters.)
- •Subjects whose retinal disease status has been stable for more than 90 days.
- •Subjects with history of iritis or uveitis in either eye.
- •Subjects who have monocular vision.
- •Subjects with a history of retinal detachment or tear in either eye.
- •Subjets with unstable IOP (i.e. > 30 mmHg in the past six months) or IOP of > 24 mm Hg at enrollment while under medical control. Subjects may be on topical medications to control their IOP.
- •Subjects with an aphakic study ete or if pseudophakic, cataract extraction surgery more than 6 months prior to study enrollment.
- •Subjects with a history of ocular trauma of any type in the study eye.
- •Subjects with media opacities or abnormalities that would preclude observation of the retina in the study eye, per the investigator's judgement.
- •Subjects that have undergone any previous vitrectomy (either anterior or pars plana vitrectomy in the study eye).
- •Subjects with a history of cataract surgery complication in the study eye.
- •Subjects that have undergone previous photocoagulation of the retina in the study eye.
- •Subjects anticipated requiring cataract extraction in the study eye within the next six (6) months.
- •Subjects with congenital eye malformations.
- •Recurrent uveitis or history of uveitis in either eye.
- •Macular edema or history of macular edema in the study eye where central macular thickness is greater than 275 microns by OCT at baseline.
- •Ongoing ocular infection or inflammation in the study eye.
- •Pregnant or nursing females.
研究组 & 干预措施
Severe Disease
Subjects with baseline BCVA between 20/16000 and hand motion (HM). Subjects received 2.0 μM concentration intravitreal injections on each Day 0 and Day 21.
干预措施: SeeQ CdSe 655 ALT (Device)
Moderate to Severe Disease
Subjects with baseline BCVA from 20/60 to 20/16000. The first five (5) to receive 2.0 μM concentration intravitreal at each Day 0 and Day 21, the subsequent five (5) to receive 0.2 μM intravitreal injection at each Day 0 and Day 21, additional subjects (up to ten [10]) to receive one of the dosing options (either 2.0 μM or 0.2 μM) at each Day 0 and Day 21, at the discretion of the Investigator and Sponsor.
干预措施: SeeQ CdSe 655 ALT (Device)
结局指标
主要结局
Change in Best Corrected Visual Acuity "BCVA"
时间窗: Measured at Baseline through Day 42
Change in ERG Amplitude
时间窗: Measured at Baseline through Day 42
ERG amplitude was measured using Poland Consult ERG equipment
Change in Visual Fields
时间窗: Measured at Baseline through Day 42
Visual Field improvement is assessed using a Humphrey/Zeiss Visual Field Analyzer
Change in Functional Vision
时间窗: Measured at Baseline through Day 42
Functional Vision is tested using Object identification and White line orientation testing
Change in Contrast Sensitivity
时间窗: Measured at Baseline through Day 42
Contrast sensitivity was measured utilizing a sin wave (Vistech) contrast sensitivity chart under photopic conditions
次要结局
- Duration of Effect(Measured at Baseline through Day 42)