Fuchs' Endothelial Dystrophy
Conditions
Brief summary
Subjects with Fuchs dystrophy will be randomized to use either netarsudil or placebo eye drops to determine if the use of netarsudil accelerates migration of host peripheral corneal endothelial cells to restore the central endothelial cell layer.
Detailed description
Subjects with Fuchs endothelial dystrophy will have the central corneal endothelium and guttae-covered Descemet membrane surgically removed. Subjects will be randomized to use netarsudil or placebo eye drops once daily. Visual acuity, corneal clearing and central endothelial cell density will be monitored for the 3-month study duration.
Interventions
DRUGNetarsudil
netarsudil opthalmic solution 0.02%
DRUGPlacebo
Placebo eye drops
Sponsors
Price Vision Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female patient at least 18 years of age and of any race or ethnicity who is undergoing Descemet stripping only for Fuchs dystrophy * Is able and willing to administer eye drops * Is able to comprehend and has signed the Informed Consent form.
Exclusion criteria
* Active intraocular inflammation * Corneal ulceration, keratitis, or conjunctivitis * Known sensitivity to any of the ingredients in the study medications * Abnormal eyelid function * History of herpetic keratitis * History of non-compliance with using prescribed medication * Current or planned pregnancy within the study duration * Concurrent involvement or participation in another randomized clinical trial within 30 days prior to enrollment in this study * Any ocular or systemic condition (i.e., UNCONTROLLED systemic disease) or situation which in the investigator's opinion may put the patient at significant risk, confound the study results, or interfere significantly with the patient's participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Corneal Clearing After Endothelial Removal for Treatment of Fuchs Dystrophy | 5 weeks | The outcome measure was the percentage area of the cornea that remained edematous after removal of the endothelium. At the time of surgery, the surgeon recorded the lengths of the major and minor axes of the approximately circular area of endothelium removal; these values were used to calculate the area of stripping. At each postoperative exam, the examiner recorded the lengths of the major and minor axes of the edematous area; these values were used to calculate the area of edema. The percentage that remained edematous at 5 weeks was calculated by dividing the area of edema at 5 weeks by the area stripped. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Netarsudil Netarsudil ophthalmic solution 0.02%, dosed topically daily for the 3-month study duration or until 2 weeks after corneal clearing is complete, whichever occurs sooner
Netarsudil: netarsudil opthalmic solution 0.02% | 10 |
| Placebo Placebo eye drop, dosed topically daily for the 3-month study duration or until 2 weeks after corneal clearing is complete, whichever occurs sooner.
Placebo: Placebo eye drops | 9 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lack of Efficacy | 0 | 1 |
Baseline characteristics
| Characteristic | Placebo | Total | Netarsudil |
|---|---|---|---|
| Age, Continuous | 58 years STANDARD_DEVIATION 17 | 62 years STANDARD_DEVIATION 14 | 65 years STANDARD_DEVIATION 10 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 9 participants | 19 participants | 10 participants |
| Sex: Female, Male Female | 8 Participants | 18 Participants | 10 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 9 |
| other Total, other adverse events | 3 / 10 | 3 / 9 |
| serious Total, serious adverse events | 0 / 10 | 0 / 9 |
Outcome results
Primary
Corneal Clearing After Endothelial Removal for Treatment of Fuchs Dystrophy
The outcome measure was the percentage area of the cornea that remained edematous after removal of the endothelium. At the time of surgery, the surgeon recorded the lengths of the major and minor axes of the approximately circular area of endothelium removal; these values were used to calculate the area of stripping. At each postoperative exam, the examiner recorded the lengths of the major and minor axes of the edematous area; these values were used to calculate the area of edema. The percentage that remained edematous at 5 weeks was calculated by dividing the area of edema at 5 weeks by the area stripped.
Time frame: 5 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Netarsudil | Corneal Clearing After Endothelial Removal for Treatment of Fuchs Dystrophy | 42 percentage of area stripped | Standard Deviation 45 |
| Placebo | Corneal Clearing After Endothelial Removal for Treatment of Fuchs Dystrophy | 43 percentage of area stripped | Standard Deviation 49 |