Efficacy of IVMED-85 on Pediatric Myopia

Официальное название

A Randomized, Controlled, Double-Masked Adaptive Design Evaluation of the Safety and Preliminary Efficacy of IVMED-85 on Pediatric Myopia

Обзор

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.

Вмешательства

• Препарат IVMED 85
  Eye drop
• Препарат Placebo
  Placebo eye drop

Первичные конечные точки

• Phase 1 Safety - Change in Best corrected distance visual acuity [Срок оценки: Baseline compared to Day 0, Weeks 1, 2 and 4 (+ 5 days)]
• Phase 1 Safety - Change in Development of corneal scarring [Срок оценки: Baseline compared to Day 0, Weeks 1, 2 and 4 (+ 5 days)]
• Phase 1 Safety - Change in Patient assessment of comfort [Срок оценки: Baseline compared to Day 0, Weeks 1,2 and 4 (+ 5 days)]
• Phase 1 Safety - Change in Tyroid enzyme levels [Срок оценки: Baseline compared to week 4]
• Phase 1 Safety - Change in Copper serum levels [Срок оценки: Baseline compared to week 4]
• Phase 2 Safety - Change in Best corrected distance visual acuity [Срок оценки: Weeks 1 and 4 (+ 5 days) and Months 3, 6, 9, and 12 (+ 21 days)]
• Phase 2 Efficacy - Change/Progression of myopic refractive error [Срок оценки: Baseline compared to month 12]

Вторичные конечные точки (6)

• Phase 2 Safety - Change in Development of corneal scarring [Срок оценки: Weeks 1 and 4 (+ 5 days) and Months 3, 6, 9, and 12 (+ 21 days)]
• Phase 2 Safety - Change in Patient assessment of comfort [Срок оценки: Weeks 1 and 4 (+ 5 days) and Months 3, 6, 9, and 12 (+ 21 days)]
• Phase 2 Efficacy - Change in keratometry [Срок оценки: Baseline compared to Weeks 1 and 4 (+ 5 days) and Months 3, 6, 9, 12 (+21 days)]
• Phase 2 Efficacy - Change in Axial length [Срок оценки: Baseline compared to Weeks 1 and 4 (+ 5 days) and Months 3, 6, 9, 12 (+21 days)]
• Phase 2 Efficacy - Change in Vitreous chamber depth [Срок оценки: 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 [Срок оценки: Baseline compared to Weeks 1 and 4 (+ 5 days) and Months 3, 6, 9 (+21 days)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

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
• Pregnancy
• Hypothyroidism or hyperthyroidism
• Patient less than 17 Kg weight
• Planned ophthalmic surgery during the study

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT05761795 · IVNA 22-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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