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

Fecha de inicio: 1 de febrero de 2024

Inclusion Criteria: * To be considered for enrollment in the study, the patient must meet all of the following criteria: 1. 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). 2. 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 3. Best corrected distance visual acuity better than or equal to Snellen 20/40 (logMAR equivalent 0.3) in both eyes 4. Kmax \>40 D and \<50 D in both eyes 5. Minimum corneal thickness \> 350 microns in both eyes 6. 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 7. Written informed consent from a parent or legal guardian and assent from participant 8. 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: 1. Current or previous myopia treatment with atropine, pirenzepine, or other topical anti-muscarinic 2. Significant central corneal scarring or hydrops 3. Known copper allergy 4. Use of rigid gas permeable lenses, including orthokeratology lenses within 90 days of screening 5. Previous cornea, glaucoma, eyelid, strabismus (exotropia or esotropia) or intraocular surgeries 6. 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) 7. Myopic degeneration with potential visual acuity worse than Snellen 20/40 (logMAR equivalent 0.3) 8. Intraocular pressure \>26 mmHg 9. 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) 10. Participation in a clinical trial with use of any investigational drug or treatment within 30 days prior to Visit 1 11. Employees of the study site or their immediate families 12. Pregnancy 13. Hypothyroidism or hyperthyroidism 14. Patient less than 17 Kg weight 15. Planned ophthalmic surgery during the study