A Phase 2a Study to Evaluate Safety and Tolerability After Single Administration of PER-001 Intravitreal Implant in Participants With Diabetic Retinopathy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Ocular Adverse events
研究概览
简要总结
This is a Phase 2a, randomized, single-masked (participant), sham controlled clinical study.
详细描述
This clinical study is a randomized, single-masked (participant) study to further investigate the ocular and systemic safety and tolerability of the two dose levels of PER-001 Intravitreal Implants in participants with diabetic retinopathy. Participants who meet entry criteria will be randomized to receive either dose of PER-001 or sham control. A total of approximately 24 participants (12 in each Cohort, will be randomized).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Placebo sham
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must be ≥ 18 years of age at the time of signing the informed consent
- •A negative pregnancy test for females of childbearing potential at Screening (serum) and Day 1 (urine).
- •Best-corrected visual acuity (BCVA) of ≥ 60 Early Treatment Diabetic Retinopathy Study (ETDRS) letters (Snellen equivalent of 20/63 or better) at Screening in potentially eligible eye(s) and prior to randomization at Day 1 in the study eye
- •Moderately severe to severe non-proliferative diabetic retinopathy (NPDR) (diabetic retinopathy severity scale [DRSS] of 47 to 53) within the standard 7-field ETDRS.
排除标准
- •Hemoglobin A1c >12%, or if HbA1c ≤12%, diabetes mellitus is uncontrolled in the opinion of the investigator
- •Any condition which, in the opinion of the investigator, would preclude the participant's ability to comply with study requirements including completion of the study (including but not limited to diagnosis of dementia, Alzheimer's, and/or other neurological disease or physical incapacity)
- •Females who are pregnant, nursing, or planning a pregnancy during the study
- •Active cancer within past 12 months except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma or prostate cancer
- •Uncontrolled blood pressure (defined as systolic >180 or diastolic >110 mmHg while the participant is sitting).
- •Currently untreated diabetes mellitus or previously untreated participants who initiated oral anti-diabetic medication or insulin within 3 months prior to Day 1
- •History of cerebrovascular accident or myocardial infarction within 6 months prior to Day 1
- •Uncontrolled atrial fibrillation
- •Systemic anti-VEGF treatment within 4 months prior to Day 1
- •Any significant media opacity which precludes clinical evaluation and imaging of the retina
- •Presence of centrally involved DME (within 500 μm of the foveal center) at Screening and Day 1
- •Tractional retinal detachment, pre-retinal fibrosis, vitreomacular traction, or epiretinal membrane involving the fovea or disrupting the macular architecture
- •Active rubeosis
- •History of vitrectomy surgery or retinal detachment or macular hole (Stage 3 or 4)
- •Uncomplicated cataract surgery within 3 months of Screening or yttrium-aluminum- garnet capsulotomy (YAG) within 4 weeks of Screening
- •Aphakia or absence of posterior capsule
- •Evidence of uncontrolled glaucoma (intraocular pressure must be < 25 mmHg) at Screening
- •History of recurrent infectious or inflammatory ocular disease
- •Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis (Note: mild blepharitis is permitted if stable)
- •Any active uveitis and/or vitritis or history of idiopathic or autoimmune-associated uveitis
- •History of herpetic ocular diseases
研究组 & 干预措施
Phase 2 Cohort A
Cohort A - Low Dose or Sham
干预措施: PER-001 Intravitreal Implant - Sham (Drug)
Phase 2 Cohort A
Cohort A - Low Dose or Sham
干预措施: PER-001 Intravitreal Implant - Low Dose (Drug)
Phase 2 Cohort B
Cohort B - High Dose or Sham
干预措施: PER-001 Intravitreal Implant - High Dose (Drug)
Phase 2 Cohort B
Cohort B - High Dose or Sham
干预措施: PER-001 Intravitreal Implant - Sham (Drug)
结局指标
主要结局
Ocular Adverse events
时间窗: End of Study(Week 24)
Frequency, severity and timing of ocular adverse events reported during the study will have verbatim terms mapped to corresponding thesaurus terms from the Medical Dictionary for Regulatory Activities coding dictionary and reported in a table summary for each active and sham participants
Best-corrected Visual Acuity (BCVA)
时间窗: End of Study(Week 24)
Change in BCVA from Baseline at Week 24 using BETDRS or modified ETDRS chart (Charts 1, 2, and R as applicable) with standardized distance and lighting ill be used to calculate the LogMAR score
Systemic Adverse events
时间窗: End of Study(Week 24)
Frequency, severity and timing of systemic adverse events reported during the study will have verbatim terms mapped to corresponding thesaurus terms from the Medical Dictionary for Regulatory Activities coding dictionary and reported in a table summary for each active and sham participants
Intraocular Pressure (IOP)
时间窗: End of Study(Week 24)
IOP change from Baseline at Week 24 as measured by a calibrated Goldmann applanation tonometry.
次要结局
未报告次要终点