Myopia, ProgressivePhase 1/2NCT05761795
Efficacy of IVMED-85 on Pediatric Myopia
A Phase 1/2 study testing IVMED 85 in people with Myopia, Progressive, run by iVeena Delivery Systems, Inc..
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. Read more about this study
- Who is it for?
- Ages 5 to 16 years
- Conditions the study is for
- Myopia, Progressive
- What is being tested?
- IVMED 85
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 216 participants
- Where
- No sites listed yet
- Study dates
- Feb 2024to Dec 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Myopia, Progressive
- Being tested
- IVMED 85, Placebo
- Medical subject headings
- Myopia, Degenerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVMED 85Drug
Eye drop
PlaceboDrug
Placebo eye drop
| Study group | Role | What they receive |
|---|---|---|
| IVMED-85 Low Dose and placebo | Experimental | Total subjects n=6 n=4 IVMED 85 Low Dose n=2 placebo BID for 1 month Receives: 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 Receives: 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 Receives: Drug: IVMED 85; Drug: Placebo |
| IVMED-85 Low Dose | Experimental | Total subjects n=48 IVMED 85 Low Dose BID for 12 month Receives: Drug: IVMED 85 |
| IVMED-85 Mid Dose | Experimental | Total subjects n=48 IVMED 85 Mid Dose BID for 12 month Receives: Drug: IVMED 85 |
| IVMED-85 High Dose | Experimental | Total subjects n=48 IVMED 85 High Dose BID for 12 month Receives: Drug: IVMED 85 |
| Placebo | Placebo comparator | Total subjects n=54 Placebo BID for 12 month Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1 Safety - Change in Best corrected distance visual acuity
Best corrected distance visual acuity in the Study Eye
Measured: 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
Measured: 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
Measured: Baseline compared to Day 0, Weeks 1,2 and 4 (+ 5 days)
Phase 1 Safety - Change in Tyroid enzyme levels
Thyroid enzyme levels
Measured: Baseline compared to week 4
Phase 1 Safety - Change in Copper serum levels
Copper serum levels
Measured: Baseline compared to week 4
Phase 2 Safety - Change in Best corrected distance visual acuity
Best corrected distance visual acuity in the Study Eye
Measured: 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
Measured: Baseline compared to month 12
Secondary outcomes (6)
Phase 2 Safety - Change in Development of corneal scarring
Development of corneal scarring in the study eye
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline compared to Weeks 1 and 4 (+ 5 days) and Months 3, 6, 9 (+21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2023
- Study startFeb 2024 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myopia, ProgressiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- iVeena Delivery Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sarah Molokhia, Principal investigator, iVeena Delivery Systems, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05761795
- Sponsor's protocol ID
- IVNA 22-01
- Status last verified
- Sep 2023
- First submitted
- 23 Feb 2023
- Last updated
- 29 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Double-Masked Adaptive Design Evaluation of the Safety and Preliminary Efficacy of IVMED-85 on Pediatric Myopia
- ClinicalTrials.gov ID
- NCT05761795
- Acronym / sponsor ID
- IVNA 22-01
- Conditions
- Myopia, Progressive
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- iVeena Delivery Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2024 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 9 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| IVMED-85 Low Dose and placebo | Experimental | Drug: IVMED 85, Drug: PlaceboTotal subjects n=6 n=4 IVMED 85 Low Dose n=2 placebo BID for 1 month |
| IVMED-85 Mid Dose and placebo | Experimental | Drug: IVMED 85, Drug: PlaceboTotal subjects n=6 n=4 IVMED 85 Mid Dose n=2 placebo BID for 1 month |
| IVMED-85 High Dose and placebo | Experimental | Drug: IVMED 85, Drug: PlaceboTotal subjects n=6 n=4 IVMED 85 High Dose n=2 placebo BID for 1 month |
| IVMED-85 Low Dose | Experimental | Drug: IVMED 85Total subjects n=48 IVMED 85 Low Dose BID for 12 month |
| IVMED-85 Mid Dose | Experimental | Drug: IVMED 85Total subjects n=48 IVMED 85 Mid Dose BID for 12 month |
| IVMED-85 High Dose | Experimental | Drug: IVMED 85Total subjects n=48 IVMED 85 High Dose BID for 12 month |
| Placebo | Placebo comparator | Drug: PlaceboTotal subjects n=54 Placebo BID for 12 month |
Who may qualify
- Ages
- 5 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- To be considered for enrollment in the study, the patient must meet all of the following criteria:
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IVMED 85Eye drop | Drug | 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 |
| PlaceboPlacebo eye drop | Drug | IVMED-85 High Dose and placebo, IVMED-85 Low Dose and placebo, IVMED-85 Mid Dose and placebo, Placebo |
Primary outcome
Phase 1 Safety - Change in Best corrected distance visual acuity
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline compared to week 4
Thyroid enzyme levels
Phase 1 Safety - Change in Copper serum levels
Time frame: Baseline compared to week 4
Copper serum levels
Phase 2 Safety - Change in Best corrected distance visual acuity
Time frame: 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
Time frame: Baseline compared to month 12
Change/Progression of myopic refractive error (spherical equivalent as determined by cycloplegic refraction) in the Study Eye
6 secondary outcomes
Phase 2 Safety - Change in Development of corneal scarring
Time frame: Weeks 1 and 4 (+ 5 days) and Months 3, 6, 9, and 12 (+ 21 days)
Phase 2 Safety - Change in Patient assessment of comfort
Time frame: Weeks 1 and 4 (+ 5 days) and Months 3, 6, 9, and 12 (+ 21 days)
Phase 2 Efficacy - Change in keratometry
Time frame: Baseline compared to Weeks 1 and 4 (+ 5 days) and Months 3, 6, 9, 12 (+21 days)
Phase 2 Efficacy - Change in Axial length
Time frame: 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
Time frame: 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
Time frame: Baseline compared to Weeks 1 and 4 (+ 5 days) and Months 3, 6, 9 (+21 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sarah Molokhia principal investigator
iVeena Delivery Systems, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IVMED 85 in people with Myopia, Progressive, run by iVeena Delivery Systems, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Molokhia, RPH, PhD (3852294491, sarahmolokhia@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1 Safety - Change in Best corrected distance visual acuity (time frame: Baseline compared to Day 0, Weeks 1, 2 and 4 (+ 5 days)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2023.