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Safety and Preliminary Efficacy of IVMED-80 Eye Drops in Keratoconus Patients

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ClinicalTrials.gov Identifier: NCT05241145
Recruitment Status : Completed
First Posted : February 15, 2022
Last Update Posted : February 15, 2022
Sponsor:
Collaborator:
Codet Vision Institute
Information provided by (Responsible Party):
iVeena Delivery Systems, Inc.

Brief Summary:
We investigated the use of a copper sulfate eye drop (IVMED-80) for the treatment of keratoconus. Preliminary laboratory data shows that the addition of copper sulfate increase crosslinking of the structural proteins of the cornea thereby halting the progressing corneal thinning and bulging seen in keratoconus. We conducted a Phase 1/2a study to evaluate the safety and preliminary efficacy of a 6-week and a 16-week regimen using IVMED-80 and studied its impact on ocular safety and the change/progression in patients' vision and clinical measurements.

Condition or disease Intervention/treatment Phase
Keratoconus Corneal Ectasia Drug: IVMED-80 Other: Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study used a three-arm, parallel design. Eligible study patients were randomly assigned to 1 of 3 treatment group following a 1:1:1 schedule.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The investigational products, IVMED-80 or Placebo (IVMED-80 vehicle solution) eye drops, were masked to all sponsor and site personnel with the exception of those directly involved with the production, labeling and shipping of product to the study sites. During the study, the identity of the test articles and randomization were not revealed. An unmasked study coordinator managed test article receipt, dispensing and inventory at the study site. Investigators who interacted with study patients to assess safety and efficacy were masked as to the identity of the test articles and treatment group assignments.
Primary Purpose: Treatment
Official Title: A Randomized, Controlled, Double-Masked Evaluation of the Safety and Preliminary Efficacy of IVMED-80 on Keratoconus Progression
Actual Study Start Date : February 8, 2019
Actual Primary Completion Date : July 8, 2020
Actual Study Completion Date : July 8, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: IVMED-6Wk
In Group 1 (IVMED-6Wk), patients instilled IVMED-80 eye drops into their study eye twice a day for 6 weeks and were followed for an additional 20 weeks without treatment (total 26 weeks)
Drug: IVMED-80
Good Manufacturing Practices-grade copper (ІІ) sulfate pentahydrate (CuSO4 #5H2O MW 249.69) was dissolved in a vehicle solution comprised of a balanced salt solution (BSS) with osmolality of approximately 500 mOsm/L. Copper sulfate was concentrated to 0.15 mg/mL. The drops were manufactured on prior to the study at a compounding pharmacy in Salt Lake City, Utah.

Experimental: IVMED-16Wk
In Group 2 (IVMED-16Wk), patients instilled IVMED-80 eye drops into their study eye twice a day for 16 weeks and were followed for an additional 10 weeks without treatment (total 26 weeks)
Drug: IVMED-80
Good Manufacturing Practices-grade copper (ІІ) sulfate pentahydrate (CuSO4 #5H2O MW 249.69) was dissolved in a vehicle solution comprised of a balanced salt solution (BSS) with osmolality of approximately 500 mOsm/L. Copper sulfate was concentrated to 0.15 mg/mL. The drops were manufactured on prior to the study at a compounding pharmacy in Salt Lake City, Utah.

Placebo Comparator: Placebo
In Group 3 (Placebo), patients instilled IVMED-80 vehicle solution eye drops into their study eye twice a day for 16 weeks and were followed for an additional 10 weeks without treatment (total 26 weeks)
Other: Placebo
This was identical to the IVMED-80 product, but without the active ingredient, copper sulfate.
Other Name: IVMED-80 Vehicle




Primary Outcome Measures :
  1. Mean Maximum Central Keratometry (Kmax) [ Time Frame: 26 weeks ]
    Change in maximum central keratometry after the assigned treatment was compared with baseline measures. This will be evaluated with and without z-score imputation. It will also be evaluated with a linear mixed effects model.

  2. Number of Treatment-Emergent Adverse Events [ Time Frame: 26 Weeks ]
    Treatment-emergent adverse events (TEAEs) were defined as events requiring additional treatments or cessation of the study article for which the date of onset was on or after the date of first dose of double-masked study drug at Day 0.

  3. Mean Best Corrected Distance Visual Acuity (BCVA) [ Time Frame: 26 Weeks ]
    Change in BCVA after the assigned treatment was compared with baseline measures.


Secondary Outcome Measures :
  1. Mean Corneal Astigmatism [ Time Frame: 26 Weeks ]
    Corneal astigmatism after the assigned treatment was compared with baseline measures.

  2. Mean Central Keratometry (Kmean) [ Time Frame: 26 Weeks ]
    The mean central keratometry after the assigned treatment was compared with baseline measures.

  3. Mean Posterior Maximum Corneal Elevation [ Time Frame: 26 Weeks ]
    Mean Posterior Maximum Corneal Elevation after the assigned treatment was compared with baseline measures.

  4. Mean Endothelial Cell Count (ECC) [ Time Frame: 26 Weeks ]
    Mean EEC after the assigned treatment was compared with baseline measures.

  5. Percentage of patients with discomfort and redness upon instillation [ Time Frame: 26 Weeks ]
    Percentage of patients with discomfort and redness upon instillation over the study period was reported.

  6. Mean Corneal hysteresis [ Time Frame: 26 weeks ]
    Mean Corneal hysteresis after the assigned treatment was compared with baseline measures with the Ocular Response Analyzer.

  7. Mean Corneal resistance factor (CRF) [ Time Frame: 26 weeks ]
    Mean Corneal resistance factor after the assigned treatment was compared with baseline measures with the Ocular Response Analyzer.

  8. Mean Central Corneal Thickness (CCT) [ Time Frame: 26 weeks ]
    The mean CCT after the assigned treatment was compared with baseline measures.

  9. Mean Minimal Corneal Thickness [ Time Frame: 26 weeks ]
    The mean Minimal Corneal Thickness after the assigned treatment was compared with baseline measures.

  10. Mean Intraocular Pressure (IOP) [ Time Frame: 26 weeks ]
    The mean IOP after the assigned treatment was compared with baseline measures.

  11. Mean Uncorrected Visual Acuity (UCVA) [ Time Frame: 26 Weeks ]
    The mean UCVA after the assigned treatment was compared with baseline measures.

  12. Mean Stiffness parameter highest concavity (SP-HC) [ Time Frame: 26 Weeks ]
    Mean SP-HC after the assigned treatment was compared with baseline measures with the Oculus Corvis.

  13. Mean Stress-strain index (SSI) [ Time Frame: 26 Weeks ]
    Mean SSI after the assigned treatment was compared with baseline measures with the Oculus Corvis.

  14. Mean Peak distance [ Time Frame: 26 Weeks ]
    Mean Peak distance after the assigned treatment was compared with baseline measures with the Oculus Corvis.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Mild to moderate keratoconus and/or corneal ectasia post-LASIK or Photo-Refractive Keratectomy
  2. Age 18 to 40
  3. Minimum corneal thickness of > 350 microns
  4. Maximum corneal keratometry of 45 D to 67 D
  5. Absence of systemic comorbidities that pose a significant surgical risk
  6. Absence of ocular comorbidities
  7. Willing and able to comply with clinic visits and study-related procedures.
  8. Provide signed informed consent

Exclusion Criteria:

  1. Significant central corneal scarring or hydrops
  2. Previous corneal surgeries
  3. Presence of pre-existing glaucoma, uveitis, uncontrolled diabetic retinopathy, or prior ocular trauma or prior intraocular surgery.
  4. Myopic degeneration with potential acuity less than 20/40 in the Study Eye.
  5. Down's Syndrome, retinitis pigmentosa, Ehlers-Danlos Syndrome, osteogenesis imperfecta (or other collagen disorder) or Anton's Syndrome.
  6. Prior retinal detachment involving the macula
  7. Received a sub-Tenon's injection of corticosteroid within the past 6 months, or any intravitreal injection within the past 6 months in the study eye prior to Visit 1
  8. Current use, or anticipated initiation during the study, of a systemic corticosteroid or an immunosuppressant agent by any route (oral, injectables)
  9. History or current condition of substance or alcohol abuse within the past year
  10. Participation in a clinical trial with use of any investigational drug or treatment within 30 days prior to Visit 1
  11. Employee of the study site or their immediate families.
  12. Pregnancy or planning to become pregnant.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05241145


Locations
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Mexico
Codet Vision Institute
Tijuana, Baja California, Mexico, 22320
Sponsors and Collaborators
iVeena Delivery Systems, Inc.
Codet Vision Institute
Investigators
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Principal Investigator: Arturo Chayet, MD Codet Vision Institute
Study Director: Balamurali K. Ambati, MD, PhD iVeena Delivery Systems
Publications:
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Responsible Party: iVeena Delivery Systems, Inc.
ClinicalTrials.gov Identifier: NCT05241145    
Other Study ID Numbers: IVNA 17-02
First Posted: February 15, 2022    Key Record Dates
Last Update Posted: February 15, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD will be shared in a journal publication.
Time Frame: Data will become available pending journal publication time frames.
Access Criteria: Data will be displayed in figures and tables and as supplemental files in the published journal and accessibility will depend on journal open access policies.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by iVeena Delivery Systems, Inc.:
Keratoconus
Corneal Ectasia
Copper
Micronutrients
Eye drops
Topical Therapy
Additional relevant MeSH terms:
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Keratoconus
Dilatation, Pathologic
Corneal Diseases
Eye Diseases
Pathological Conditions, Anatomical