Efficacy of IVMED-85 on Pediatric Myopia

iVeena Delivery Systems

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Myopia, Progressive

Treatments: Drug: Placebo; Drug: IVMED 85

Study type: Interventional

Funder types: Industry

Identifiers

NCT05761795

IVNA 22-01

Details and patient eligibility

About

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.

Enrollment: 216 estimated patients

Sex: All

Ages: 5 to 16 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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216 participants in 7 patient groups, including a placebo group

IVMED-85 Low Dose and placebo

Experimental group

Description:

Total subjects n=6 n=4 IVMED 85 Low Dose n=2 placebo BID for 1 month

Treatment:

Drug: IVMED 85

Drug: Placebo

IVMED-85 Mid Dose and placebo

Experimental group

Description:

Total subjects n=6 n=4 IVMED 85 Mid Dose n=2 placebo BID for 1 month

Treatment:

Drug: IVMED 85

Drug: Placebo

IVMED-85 High Dose and placebo

Experimental group

Description:

Total subjects n=6 n=4 IVMED 85 High Dose n=2 placebo BID for 1 month

Treatment:

Drug: IVMED 85

Drug: Placebo

IVMED-85 Low Dose

Experimental group

Description:

Total subjects n=48 IVMED 85 Low Dose BID for 12 month

Treatment:

Drug: IVMED 85

IVMED-85 Mid Dose

Experimental group

Description:

Total subjects n=48 IVMED 85 Mid Dose BID for 12 month

Treatment:

Drug: IVMED 85

IVMED-85 High Dose

Experimental group

Description:

Total subjects n=48 IVMED 85 High Dose BID for 12 month

Treatment:

Drug: IVMED 85

Placebo

Placebo Comparator group

Description:

Total subjects n=54 Placebo BID for 12 month

Treatment:

Drug: Placebo