Efficacy of IVMED-85 on Pediatric Myopia

NCT05761795 | Not Yet Recruiting Phase 1

• 1 other identifier: IVNA 22-01
• Study Type: interventional
• Target: 216
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Myopia, Progressive

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (6)

• Phase 2 Safety - Change in Development of corneal scarring

  Weeks 1 and 4 (+ 5 days) and Months 3, 6, 9, and 12 (+ 21 days)

• Phase 2 Safety - Change in Patient assessment of comfort

  Weeks 1 and 4 (+ 5 days) and Months 3, 6, 9, and 12 (+ 21 days)

• Phase 2 Efficacy - Change in keratometry

  Baseline compared to Weeks 1 and 4 (+ 5 days) and Months 3, 6, 9, 12 (+21 days)

• Phase 2 Efficacy - Change in Axial length

  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

  Baseline compared to Weeks 1 and 4 (+ 5 days) and Months 3, 6, 9, 12 (+21 days)

Study Arms (7)

IVMED-85 Low Dose and placebo

EXPERIMENTAL

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

Drug: IVMED 85; Drug: Placebo

IVMED-85 Mid Dose and placebo

EXPERIMENTAL

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

Drug: IVMED 85; Drug: Placebo

IVMED-85 High Dose and placebo

EXPERIMENTAL

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

Drug: IVMED 85; Drug: Placebo

IVMED-85 Low Dose

EXPERIMENTAL

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

Drug: IVMED 85

IVMED-85 Mid Dose

EXPERIMENTAL

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

Drug: IVMED 85

IVMED-85 High Dose

EXPERIMENTAL

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

Drug: IVMED 85

Placebo

PLACEBO COMPARATOR

Total subjects n=54 Placebo BID for 12 month

Drug: Placebo

Interventions

IVMED 85 DRUG

Eye drop

IVMED-85 High Dose; IVMED-85 High Dose and placebo; IVMED-85 Low Dose; IVMED-85 Low Dose and placebo; IVMED-85 Mid Dose; IVMED-85 Mid Dose and placebo

Placebo DRUG

Placebo eye drop

IVMED-85 High Dose and placebo; IVMED-85 Low Dose and placebo; IVMED-85 Mid Dose and placebo; Placebo

Eligibility Criteria

• Age: 5 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• iVeena Delivery Systems, Inc.: lead

MeSH Terms

Conditions

Myopia, Degenerative

Condition Hierarchy (Ancestors)

Myopia; Refractive Errors; Eye Diseases

Study Officials

• Sarah Molokhia

  iVeena Delivery Systems, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Molokhia, RPH, PhD

CONTACT

3852294491; sarahmolokhia@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2023
• First Posted: March 9, 2023
• Study Start: February 1, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 29, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share