Keratoconus Clinical Trial
Official title:
A Randomized, Controlled, Double-Masked Evaluation of the Safety and Preliminary Efficacy of IVMED-80 on Keratoconus Progression
Verified date | February 2022 |
Source | iVeena Delivery Systems, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 38 |
Est. completion date | July 8, 2020 |
Est. primary completion date | July 8, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 40 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Mexico | Codet Vision Institute | Tijuana | Baja California |
Lead Sponsor | Collaborator |
---|---|
iVeena Delivery Systems, Inc. | Codet Vision Institute |
Mexico,
Kymes SM, Walline JJ, Zadnik K, Sterling J, Gordon MO; Collaborative Longitudinal Evaluation of Keratoconus Study Group. Changes in the quality-of-life of people with keratoconus. Am J Ophthalmol. 2008 Apr;145(4):611-617. doi: 10.1016/j.ajo.2007.11.017. Epub 2008 Jan 28. — View Citation
Olivares Jiménez JL, Guerrero Jurado JC, Bermudez Rodriguez FJ, Serrano Laborda D. Keratoconus: age of onset and natural history. Optom Vis Sci. 1997 Mar;74(3):147-51. — View Citation
Wagner H, Barr JT, Zadnik K. Collaborative Longitudinal Evaluation of Keratoconus (CLEK) Study: methods and findings to date. Cont Lens Anterior Eye. 2007 Sep;30(4):223-32. Epub 2007 May 3. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean Maximum Central Keratometry (Kmax) | 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. | 26 weeks | |
Primary | Number of Treatment-Emergent Adverse Events | 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. | 26 Weeks | |
Primary | Mean Best Corrected Distance Visual Acuity (BCVA) | Change in BCVA after the assigned treatment was compared with baseline measures. | 26 Weeks | |
Secondary | Mean Corneal Astigmatism | Corneal astigmatism after the assigned treatment was compared with baseline measures. | 26 Weeks | |
Secondary | Mean Central Keratometry (Kmean) | The mean central keratometry after the assigned treatment was compared with baseline measures. | 26 Weeks | |
Secondary | Mean Posterior Maximum Corneal Elevation | Mean Posterior Maximum Corneal Elevation after the assigned treatment was compared with baseline measures. | 26 Weeks | |
Secondary | Mean Endothelial Cell Count (ECC) | Mean EEC after the assigned treatment was compared with baseline measures. | 26 Weeks | |
Secondary | Percentage of patients with discomfort and redness upon instillation | Percentage of patients with discomfort and redness upon instillation over the study period was reported. | 26 Weeks | |
Secondary | Mean Corneal hysteresis | Mean Corneal hysteresis after the assigned treatment was compared with baseline measures with the Ocular Response Analyzer. | 26 weeks | |
Secondary | Mean Corneal resistance factor (CRF) | Mean Corneal resistance factor after the assigned treatment was compared with baseline measures with the Ocular Response Analyzer. | 26 weeks | |
Secondary | Mean Central Corneal Thickness (CCT) | The mean CCT after the assigned treatment was compared with baseline measures. | 26 weeks | |
Secondary | Mean Minimal Corneal Thickness | The mean Minimal Corneal Thickness after the assigned treatment was compared with baseline measures. | 26 weeks | |
Secondary | Mean Intraocular Pressure (IOP) | The mean IOP after the assigned treatment was compared with baseline measures. | 26 weeks | |
Secondary | Mean Uncorrected Visual Acuity (UCVA) | The mean UCVA after the assigned treatment was compared with baseline measures. | 26 Weeks | |
Secondary | Mean Stiffness parameter highest concavity (SP-HC) | Mean SP-HC after the assigned treatment was compared with baseline measures with the Oculus Corvis. | 26 Weeks | |
Secondary | Mean Stress-strain index (SSI) | Mean SSI after the assigned treatment was compared with baseline measures with the Oculus Corvis. | 26 Weeks | |
Secondary | Mean Peak distance | Mean Peak distance after the assigned treatment was compared with baseline measures with the Oculus Corvis. | 26 Weeks |
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