A Randomized, Controlled, Double-Masked Adaptive Design Evaluation of the Safety and Preliminary Efficacy of IVMED-85 on Pediatric Myopia
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 216
- 主要终点
- Phase 1 Safety - Change in Development of corneal scarring
研究概览
简要总结
The goal of this clinical trial is to evaluate the safety and preliminary efficacy of a 1-year course of IVMED-85 eye drops for the treatment of pediatric myopia by assessing its safety effects on visual acuity and its effect on the change and/or progression of myopia.
The main question[s] it aims to answer are:
- Does IVMED 85 improve visual acuity
- Does IVMED 85 slow or otherwise change the progression of myopia
Participants will use eyedrops twice a day for one year. Researchers will compare IVMED 85 to a placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 5 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be considered for enrollment in the study, the patient must meet all of the following criteria:
- •Age 5 to 16 years and 6 months, three age groups cohorts (5-8), (9-12), and (13-16) (Phase 1 patients will be exclusively age 13-16).
- •Refractive error by cycloplegic refraction in both eyes: myopia -0.75 D to -9.75 D spherical equivalent; astigmatism ≤ 4.00D; anisometropia <3.00 D
- •Best corrected distance visual acuity better than or equal to Snellen 20/40 (logMAR equivalent 0.3) in both eyes
- •Kmax >40 D and <50 D in both eyes
- •Minimum corneal thickness > 350 microns in both eyes
- •Absence of ocular comorbidities (glaucoma, cataract, anterior segment dysgenesis, corneal scarring, juvenile rheumatoid arthritis, lens subluxation, uveitis, collagen disorders (Ehlers-Danlos, Marfan's syndrome, osteogenesis imperfecta, retinal diseases) in both eyes
- •Written informed consent from a parent or legal guardian and assent from participant
- •Willing and able to comply with clinic visits and study-related procedures.
排除标准
- •A patient who meets any of the following criteria, in either eye, will be excluded from the study:
- •Current or previous myopia treatment with atropine, pirenzepine, or other topical anti-muscarinic
- •Significant central corneal scarring or hydrops
- •Known copper allergy
- •Use of rigid gas permeable lenses, including orthokeratology lenses within 90 days of screening
- •Previous cornea, glaucoma, eyelid, strabismus (exotropia or esotropia) or intraocular surgeries
- •Prior history of ocular disorder (e.g., current or prior history of strabismus (exotropia or esotropia), amblyopia, glaucoma, cataract, retinal detachment or nystagmus, or abnormality of the cornea, lens, iris, ciliary body, or central retina)
- •Myopic degeneration with potential visual acuity worse than Snellen 20/40 (logMAR equivalent 0.3)
- •Intraocular pressure >26 mmHg
- •Medical conditions pre-disposing patient to degenerative myopia or abnormal ocular refractive anatomy (e.g., Stickler Syndrome, Down Syndrome, osteogenesis imperfecta, Ehler's-Danlos Syndrome, Retinopathy of Prematurity)
- •Participation in a clinical trial with use of any investigational drug or treatment within 30 days prior to Visit 1
- •Employees of the study site or their immediate families
- •Hypothyroidism or hyperthyroidism
- •Patient less than 17 Kg weight
- •Planned ophthalmic surgery during the study
研究组 & 干预措施
IVMED-85 Low Dose and placebo
Total subjects n=6 n=4 IVMED 85 Low Dose n=2 placebo BID for 1 month
干预措施: IVMED 85 (Drug)
IVMED-85 Low Dose and placebo
Total subjects n=6 n=4 IVMED 85 Low Dose n=2 placebo BID for 1 month
干预措施: Placebo (Drug)
IVMED-85 Mid Dose and placebo
Total subjects n=6 n=4 IVMED 85 Mid Dose n=2 placebo BID for 1 month
干预措施: IVMED 85 (Drug)
IVMED-85 Mid Dose and placebo
Total subjects n=6 n=4 IVMED 85 Mid Dose n=2 placebo BID for 1 month
干预措施: Placebo (Drug)
IVMED-85 High Dose and placebo
Total subjects n=6 n=4 IVMED 85 High Dose n=2 placebo BID for 1 month
干预措施: IVMED 85 (Drug)
IVMED-85 High Dose and placebo
Total subjects n=6 n=4 IVMED 85 High Dose n=2 placebo BID for 1 month
干预措施: Placebo (Drug)
IVMED-85 Low Dose
Total subjects n=48 IVMED 85 Low Dose BID for 12 month
干预措施: IVMED 85 (Drug)
IVMED-85 Mid Dose
Total subjects n=48 IVMED 85 Mid Dose BID for 12 month
干预措施: IVMED 85 (Drug)
IVMED-85 High Dose
Total subjects n=48 IVMED 85 High Dose BID for 12 month
干预措施: IVMED 85 (Drug)
Placebo
Total subjects n=54 Placebo BID for 12 month
干预措施: Placebo (Drug)
结局指标
主要结局
Phase 1 Safety - Change in Development of corneal scarring
时间窗: Baseline compared to Day 0, Weeks 1, 2 and 4 (+ 5 days)
Development of corneal scarring in the study eye
Phase 1 Safety - Change in Tyroid enzyme levels
时间窗: Baseline compared to week 4
Thyroid enzyme levels
Phase 1 Safety - Change in Copper serum levels
时间窗: Baseline compared to week 4
Copper serum levels
Phase 2 Efficacy - Change/Progression of myopic refractive error
时间窗: Baseline compared to month 12
Change/Progression of myopic refractive error (spherical equivalent as determined by cycloplegic refraction) in the Study Eye
Phase 2 Safety - Change in Best corrected distance visual acuity
时间窗: Weeks 1 and 4 (+ 5 days) and Months 3, 6, 9, and 12 (+ 21 days)
Best corrected distance visual acuity in the Study Eye
Phase 1 Safety - Change in Best corrected distance visual acuity
时间窗: Baseline compared to Day 0, Weeks 1, 2 and 4 (+ 5 days)
Best corrected distance visual acuity in the Study Eye
Phase 1 Safety - Change in Patient assessment of comfort
时间窗: Baseline compared to Day 0, Weeks 1,2 and 4 (+ 5 days)
Patient assessment of burning, redness, discomfort, irritation in the study eye
次要结局
- Phase 2 Safety - Change in Development of corneal scarring(Weeks 1 and 4 (+ 5 days) and Months 3, 6, 9, and 12 (+ 21 days))
- Phase 2 Efficacy - Change in keratometry(Baseline compared to Weeks 1 and 4 (+ 5 days) and Months 3, 6, 9, 12 (+21 days))
- Phase 2 Efficacy - Change in Axial length(Baseline compared to Weeks 1 and 4 (+ 5 days) and Months 3, 6, 9, 12 (+21 days))
- Phase 2 Safety - Change in Patient assessment of comfort(Weeks 1 and 4 (+ 5 days) and Months 3, 6, 9, and 12 (+ 21 days))
- Phase 2 Efficacy - Change in Vitreous chamber depth(Baseline compared to Weeks 1 and 4 (+ 5 days) and Months 3, 6, 9, 12 (+21 days))
- Phase 2 Efficacy - Intermediate change/progression of myopic refractive error(Baseline compared to Weeks 1 and 4 (+ 5 days) and Months 3, 6, 9 (+21 days))