Efficacy of IVMED-85 on Pediatric Myopia

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Myopia, Progressive
• Intervention / Treatment: Drug: Placebo; Drug: IVMED 85

• Study Type: Interventional
• Enrollment (Estimated): 216
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Sarah Molokhia, RPH, PhD; Phone Number: 3852294491; Email: sarahmolokhia@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 16 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

7

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: iVeena Delivery Systems, Inc.
• Investigators: Principal Investigator: Sarah Molokhia, iVeena Delivery Systems, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: February 23, 2023
• First Submitted That Met QC Criteria: March 7, 2023
• First Posted (Actual): March 9, 2023

Study Record Updates

• Last Update Posted (Actual): September 29, 2023
• Last Update Submitted That Met QC Criteria: September 27, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia; Myopia, Degenerative
• Other Study ID Numbers: IVNA 22-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No