Efficacy of IVMED-85 on Pediatric Myopia

Sponsor

iVeena Delivery Systems, Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05761795

Collaborator

(none)

216

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myopia, Progressive	Drug: IVMED 85 Drug: Placebo	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

216 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

May 1, 2025

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

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: IVMED 85 Eye drop Drug: Placebo Placebo 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: IVMED 85 Eye drop Drug: Placebo Placebo 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: IVMED 85 Eye drop Drug: Placebo Placebo 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

Outcome Measures

Primary Outcome Measures

Phase 1 Safety - Change in Best corrected distance visual acuity [Baseline compared to Day 0, Weeks 1, 2 and 4 (+ 5 days)]
Best corrected distance visual acuity in the Study Eye
Phase 1 Safety - Change in Development of corneal scarring [Baseline compared to Day 0, Weeks 1, 2 and 4 (+ 5 days)]
Development of corneal scarring in the study eye
Phase 1 Safety - Change in Patient assessment of comfort [Baseline compared to Day 0, Weeks 1,2 and 4 (+ 5 days)]
Patient assessment of burning, redness, discomfort, irritation in the study eye
Phase 1 Safety - Change in Tyroid enzyme levels [Baseline compared to week 4]
Thyroid enzyme levels
Phase 1 Safety - Change in Copper serum levels [Baseline compared to week 4]
Copper serum levels
Phase 2 Safety - Change in Best corrected distance visual acuity [Weeks 1 and 4 (+ 5 days) and Months 3, 6, 9, and 12 (+ 21 days)]
Best corrected distance visual acuity in the Study Eye
Phase 2 Efficacy - Change/Progression of myopic refractive error [Baseline compared to month 12]
Change/Progression of myopic refractive error (spherical equivalent as determined by cycloplegic refraction) in the Study Eye

Secondary Outcome Measures

Phase 2 Safety - Change in Development of corneal scarring [Weeks 1 and 4 (+ 5 days) and Months 3, 6, 9, and 12 (+ 21 days)]
Development of corneal scarring in the study eye
Phase 2 Safety - Change in Patient assessment of comfort [Weeks 1 and 4 (+ 5 days) and Months 3, 6, 9, and 12 (+ 21 days)]
Patient assessment of burning, redness, discomfort, irritation in the study eye
Phase 2 Efficacy - Change in keratometry [Baseline compared to Weeks 1 and 4 (+ 5 days) and Months 3, 6, 9, 12 (+21 days)]
Measure keratometry in the Study Eye
Phase 2 Efficacy - Change in Axial length [Baseline compared to Weeks 1 and 4 (+ 5 days) and Months 3, 6, 9, 12 (+21 days)]
Axial Length in the Study Eye
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)]
Vitreous chamber depth in the Study Eye
Phase 2 Efficacy - Intermediate change/progression of myopic refractive error [Baseline compared to Weeks 1 and 4 (+ 5 days) and Months 3, 6, 9 (+21 days)]
Change/Progression of myopic refractive error (spherical equivalent as determined by cycloplegic refraction) in the Study Eye

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 16 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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
Planned ophthalmic surgery during the study

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

iVeena Delivery Systems, Inc.

Investigators

Principal Investigator: Sarah Molokhia, iVeena Delivery Systems, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

iVeena Delivery Systems, Inc.

ClinicalTrials.gov Identifier:

NCT05761795

Other Study ID Numbers:

IVNA 22-01

First Posted:

Mar 9, 2023

Last Update Posted:

Mar 9, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Myopia

Myopia, Degenerative

Study Results

No Results Posted as of Mar 9, 2023