Efficacy of IVMED-85 on Pediatric Myopia

Study Overview
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Brief Summary
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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.

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

Conditions
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Myopia, Progressive

Intervention / Treatment
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* Drug: IVMED 85
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IVMED-85 Low Dose and placebo<br>Total subjects n=6 n=4 IVMED 85 Low Dose n=2 placebo BID for 1 month | Drug: IVMED 85<br>* Eye drop<br>Drug: Placebo<br>* Placebo eye drop<br>|
| Experimental: IVMED-85 Mid Dose and placebo<br>Total subjects n=6 n=4 IVMED 85 Mid Dose n=2 placebo BID for 1 month | Drug: IVMED 85<br>* Eye drop<br>Drug: Placebo<br>* Placebo eye drop<br>|
| Experimental: IVMED-85 High Dose and placebo<br>Total subjects n=6 n=4 IVMED 85 High Dose n=2 placebo BID for 1 month | Drug: IVMED 85<br>* Eye drop<br>Drug: Placebo<br>* Placebo eye drop<br>|
| Experimental: IVMED-85 Low Dose<br>Total subjects n=48 IVMED 85 Low Dose BID for 12 month | Drug: IVMED 85<br>* Eye drop<br>|
| Experimental: IVMED-85 Mid Dose<br>Total subjects n=48 IVMED 85 Mid Dose BID for 12 month | Drug: IVMED 85<br>* Eye drop<br>|
| Experimental: IVMED-85 High Dose<br>Total subjects n=48 IVMED 85 High Dose BID for 12 month | Drug: IVMED 85<br>* Eye drop<br>|
| Placebo Comparator: Placebo<br>Total subjects n=54 Placebo BID for 12 month | Drug: Placebo<br>* Placebo eye drop<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase 1 Safety - Change in Best corrected distance visual acuity | Best corrected distance visual acuity in the Study Eye | Baseline compared to Day 0, Weeks 1, 2 and 4 (+ 5 days) | 
| Phase 1 Safety - Change in Development of corneal scarring | Development of corneal scarring in the study eye | Baseline compared to Day 0, Weeks 1, 2 and 4 (+ 5 days) | 
| Phase 1 Safety - Change in Patient assessment of comfort | Patient assessment of burning, redness, discomfort, irritation in the study eye | Baseline compared to Day 0, Weeks 1,2 and 4 (+ 5 days) | 
| Phase 1 Safety - Change in Tyroid enzyme levels | Thyroid enzyme levels | Baseline compared to week 4 | 
| Phase 1 Safety - Change in Copper serum levels | Copper serum levels | Baseline compared to week 4 | 
| Phase 2 Safety - Change in Best corrected distance visual acuity | Best corrected distance visual acuity in the Study Eye | Weeks 1 and 4 (+ 5 days) and Months 3, 6, 9, and 12 (+ 21 days) | 
| Phase 2 Efficacy - Change/Progression of myopic refractive error | Change/Progression of myopic refractive error (spherical equivalent as determined by cycloplegic refraction) in the Study Eye | Baseline compared to month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase 2 Safety - Change in Development of corneal scarring | Development of corneal scarring in the study eye | Weeks 1 and 4 (+ 5 days) and Months 3, 6, 9, and 12 (+ 21 days) | 
| Phase 2 Safety - Change in Patient assessment of comfort | Patient assessment of burning, redness, discomfort, irritation in the study eye | Weeks 1 and 4 (+ 5 days) and Months 3, 6, 9, and 12 (+ 21 days) | 
| Phase 2 Efficacy - Change in keratometry | Measure keratometry in the Study Eye | Baseline compared to Weeks 1 and 4 (+ 5 days) and Months 3, 6, 9, 12 (+21 days) | 
| Phase 2 Efficacy - Change in Axial length | Axial Length in the Study Eye | 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 | Vitreous chamber depth in the Study Eye | 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 | Change/Progression of myopic refractive error (spherical equivalent as determined by cycloplegic refraction) in the Study Eye | Baseline compared to Weeks 1 and 4 (+ 5 days) and Months 3, 6, 9 (+21 days) |