Efficacy of IVMED-85 on Pediatric Myopia

Myopia, Progressive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05761795
• Other study ID #: IVNA 22-01
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: February 2024
• Est. completion date: December 2026

Study information

• Verified date: September 2023
• Source: iVeena Delivery Systems, Inc.
• Contact: Sarah Molokhia, RPH, PhD
• Phone: 3852294491
• Email: sarahmolokhia[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 216
• Est. completion date: December 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Myopia
• Myopia, Degenerative
• Myopia, Progressive

Intervention

Drug:
• IVMED 85
Eye drop
• Placebo
Placebo eye drop

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
iVeena Delivery Systems, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	Phase 1 Safety - Change in Tyroid enzyme levels	Thyroid enzyme levels	Baseline compared to week 4
Primary	Phase 1 Safety - Change in Copper serum levels	Copper serum levels	Baseline compared to week 4
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)