A Phase 1/2 interventional study of IVMED 85 and Placebo in Myopia, Progressive, sponsored by iVeena Delivery Systems, Inc.. Not yet recruiting. Open to participants aged 5 Years to 16 Years. Per ClinicalTrials.gov, last updated 2023-09-29.
Sponsored by iVeena Delivery Systems, Inc. · Phase 1/2, Interventional, and Treatment
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:
Participants will use eyedrops twice a day for one year. Researchers will compare IVMED 85 to a placebo.
984 studies on the registry are indexed under Myopia; 209 are open to participants now.
This study's planned enrollment of 216 is above the median of 80 across 782 interventional studies indexed under Myopia.
Browse Myopia studies →iVeena Delivery Systems, Inc. is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
To be considered for enrollment in the study, the patient must meet all of the following criteria:
Exclusion Criteria:
A patient who meets any of the following criteria, in either eye, will be excluded from the study:
Total subjects n=6 n=4 IVMED 85 Low Dose n=2 placebo BID for 1 month
Drug: IVMED 85 · Drug: Placebo
Total subjects n=6 n=4 IVMED 85 Mid Dose n=2 placebo BID for 1 month
Drug: IVMED 85 · Drug: Placebo
Total subjects n=6 n=4 IVMED 85 High Dose n=2 placebo BID for 1 month
Drug: IVMED 85 · Drug: Placebo
Total subjects n=48 IVMED 85 Low Dose BID for 12 month
Drug: IVMED 85
Total subjects n=48 IVMED 85 Mid Dose BID for 12 month
Drug: IVMED 85
Total subjects n=48 IVMED 85 High Dose BID for 12 month
Drug: IVMED 85
Total subjects n=54 Placebo BID for 12 month
Drug: Placebo
Eye drop
Placebo eye drop
Phase 1 Safety - Change in Best corrected distance visual acuity
Best corrected distance visual acuity in the Study Eye
Time frame: 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
Time frame: 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
Time frame: Baseline compared to Day 0, Weeks 1,2 and 4 (+ 5 days)
Phase 1 Safety - Change in Tyroid enzyme levels
Thyroid enzyme levels
Time frame: Baseline compared to week 4
Phase 1 Safety - Change in Copper serum levels
Copper serum levels
Time frame: Baseline compared to week 4
Phase 2 Safety - Change in Best corrected distance visual acuity
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)
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
Time frame: Baseline compared to month 12
Phase 2 Safety - Change in Development of corneal scarring
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)
Phase 2 Safety - Change in Patient assessment of comfort
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)
Phase 2 Efficacy - Change in keratometry
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)
Phase 2 Efficacy - Change in Axial length
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)
Phase 2 Efficacy - Change in Vitreous chamber depth
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)
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
Time frame: Baseline compared to Weeks 1 and 4 (+ 5 days) and Months 3, 6, 9 (+21 days)
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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iVeena Delivery Systems, Inc.