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Efficacy of IVMED-85 on Pediatric Myopia

Primary Purpose

Myopia, Progressive

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
IVMED 85
Placebo
Sponsored by
iVeena Delivery Systems, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia, Progressive

Eligibility Criteria

5 Years - 16 Years (Child)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm 7

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    IVMED-85 Low Dose and placebo

    IVMED-85 Mid Dose and placebo

    IVMED-85 High Dose and placebo

    IVMED-85 Low Dose

    IVMED-85 Mid Dose

    IVMED-85 High Dose

    Placebo

    Arm Description

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

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

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

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

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

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

    Total subjects n=54 Placebo BID for 12 month

    Outcomes

    Primary Outcome Measures

    Phase 1 Safety - Change in Best corrected distance visual acuity
    Best corrected distance visual acuity in the Study Eye
    Phase 1 Safety - Change in Development of corneal scarring
    Development of corneal scarring in the study eye
    Phase 1 Safety - Change in Patient assessment of comfort
    Patient assessment of burning, redness, discomfort, irritation in the study eye
    Phase 1 Safety - Change in Tyroid enzyme levels
    Thyroid enzyme levels
    Phase 1 Safety - Change in Copper serum levels
    Copper serum levels
    Phase 2 Safety - Change in Best corrected distance visual acuity
    Best corrected distance visual acuity in the Study Eye
    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

    Secondary Outcome Measures

    Phase 2 Safety - Change in Development of corneal scarring
    Development of corneal scarring in the study eye
    Phase 2 Safety - Change in Patient assessment of comfort
    Patient assessment of burning, redness, discomfort, irritation in the study eye
    Phase 2 Efficacy - Change in keratometry
    Measure keratometry in the Study Eye
    Phase 2 Efficacy - Change in Axial length
    Axial Length in the Study Eye
    Phase 2 Efficacy - Change in Vitreous chamber depth
    Vitreous chamber depth in the Study Eye
    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

    Full Information

    First Posted
    February 23, 2023
    Last Updated
    September 27, 2023
    Sponsor
    iVeena Delivery Systems, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05761795
    Brief Title
    Efficacy of IVMED-85 on Pediatric Myopia
    Official Title
    A Randomized, Controlled, Double-Masked Adaptive Design Evaluation of the Safety and Preliminary Efficacy of IVMED-85 on Pediatric Myopia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 2024 (Anticipated)
    Primary Completion Date
    May 2026 (Anticipated)
    Study Completion Date
    December 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    iVeena Delivery Systems, Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Myopia, Progressive

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    216 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    IVMED-85 Low Dose and placebo
    Arm Type
    Experimental
    Arm Description
    Total subjects n=6 n=4 IVMED 85 Low Dose n=2 placebo BID for 1 month
    Arm Title
    IVMED-85 Mid Dose and placebo
    Arm Type
    Experimental
    Arm Description
    Total subjects n=6 n=4 IVMED 85 Mid Dose n=2 placebo BID for 1 month
    Arm Title
    IVMED-85 High Dose and placebo
    Arm Type
    Experimental
    Arm Description
    Total subjects n=6 n=4 IVMED 85 High Dose n=2 placebo BID for 1 month
    Arm Title
    IVMED-85 Low Dose
    Arm Type
    Experimental
    Arm Description
    Total subjects n=48 IVMED 85 Low Dose BID for 12 month
    Arm Title
    IVMED-85 Mid Dose
    Arm Type
    Experimental
    Arm Description
    Total subjects n=48 IVMED 85 Mid Dose BID for 12 month
    Arm Title
    IVMED-85 High Dose
    Arm Type
    Experimental
    Arm Description
    Total subjects n=48 IVMED 85 High Dose BID for 12 month
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Total subjects n=54 Placebo BID for 12 month
    Intervention Type
    Drug
    Intervention Name(s)
    IVMED 85
    Intervention Description
    Eye drop
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo eye drop
    Primary Outcome Measure Information:
    Title
    Phase 1 Safety - Change in Best corrected distance visual acuity
    Description
    Best corrected distance visual acuity in the Study Eye
    Time Frame
    Baseline compared to Day 0, Weeks 1, 2 and 4 (+ 5 days)
    Title
    Phase 1 Safety - Change in Development of corneal scarring
    Description
    Development of corneal scarring in the study eye
    Time Frame
    Baseline compared to Day 0, Weeks 1, 2 and 4 (+ 5 days)
    Title
    Phase 1 Safety - Change in Patient assessment of comfort
    Description
    Patient assessment of burning, redness, discomfort, irritation in the study eye
    Time Frame
    Baseline compared to Day 0, Weeks 1,2 and 4 (+ 5 days)
    Title
    Phase 1 Safety - Change in Tyroid enzyme levels
    Description
    Thyroid enzyme levels
    Time Frame
    Baseline compared to week 4
    Title
    Phase 1 Safety - Change in Copper serum levels
    Description
    Copper serum levels
    Time Frame
    Baseline compared to week 4
    Title
    Phase 2 Safety - Change in Best corrected distance visual acuity
    Description
    Best corrected distance visual acuity in the Study Eye
    Time Frame
    Weeks 1 and 4 (+ 5 days) and Months 3, 6, 9, and 12 (+ 21 days)
    Title
    Phase 2 Efficacy - Change/Progression of myopic refractive error
    Description
    Change/Progression of myopic refractive error (spherical equivalent as determined by cycloplegic refraction) in the Study Eye
    Time Frame
    Baseline compared to month 12
    Secondary Outcome Measure Information:
    Title
    Phase 2 Safety - Change in Development of corneal scarring
    Description
    Development of corneal scarring in the study eye
    Time Frame
    Weeks 1 and 4 (+ 5 days) and Months 3, 6, 9, and 12 (+ 21 days)
    Title
    Phase 2 Safety - Change in Patient assessment of comfort
    Description
    Patient assessment of burning, redness, discomfort, irritation in the study eye
    Time Frame
    Weeks 1 and 4 (+ 5 days) and Months 3, 6, 9, and 12 (+ 21 days)
    Title
    Phase 2 Efficacy - Change in keratometry
    Description
    Measure keratometry in the Study Eye
    Time Frame
    Baseline compared to Weeks 1 and 4 (+ 5 days) and Months 3, 6, 9, 12 (+21 days)
    Title
    Phase 2 Efficacy - Change in Axial length
    Description
    Axial Length in the Study Eye
    Time Frame
    Baseline compared to Weeks 1 and 4 (+ 5 days) and Months 3, 6, 9, 12 (+21 days)
    Title
    Phase 2 Efficacy - Change in Vitreous chamber depth
    Description
    Vitreous chamber depth in the Study Eye
    Time Frame
    Baseline compared to Weeks 1 and 4 (+ 5 days) and Months 3, 6, 9, 12 (+21 days)
    Title
    Phase 2 Efficacy - Intermediate change/progression of myopic refractive error
    Description
    Change/Progression of myopic refractive error (spherical equivalent as determined by cycloplegic refraction) in the Study Eye
    Time Frame
    Baseline compared to Weeks 1 and 4 (+ 5 days) and Months 3, 6, 9 (+21 days)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Years
    Maximum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sarah Molokhia, RPH, PhD
    Phone
    3852294491
    Email
    sarahmolokhia@hotmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sarah Molokhia
    Organizational Affiliation
    iVeena Delivery Systems, Inc.
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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