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A Phase 3 Study to Investigate the Safety and Efficacy of Ripasudil (K-321) in Subjects with Fuchs Dystrophy
EU CTIS ID: 2022-502643-35-00
What this study is testing
To investigate the effect of K-321 on the time to improvement in BCVA by ETDRS letter score of ≥40 letters during the first 12 weeks after simultaneous cataract surgery and descemetorhexis in subjects with FECD.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Is at least 18 years old at the screening visit (Visit 1)
- Has a diagnosis of FECD at Visit 1
- Has confluent central guttae in the study eye that can be removed by descemetorhexis of a circular area of 5.5 mm diameter or less (at Visit 1)
- Study eye with BCVA of 75 letters or fewer by ETDRS testing (Snellen equivalent of 20/32 or worse) at Visit 1
- Has a visually significant cataract in the study eye at Visit 1
- Can understand the written informed consent, provides signed and witnessed written informed consent, and agrees to comply with protocol requirements before any study-specific assessments are performed.
You likely can't join if
- Is a female subject of childbearing potential and any of the following is true: a. is pregnant or lactating/breastfeeding, or b. is not surgically sterile, not post-menopausal (no menses for the previous 12 months), or not practicing an effective method of birth control as determined by the Investigator (eg, oral contraceptives, double barrier methods, hormonal injectable or implanted contraceptives, tubal ligation, or partner with vasectomy)
- Has a study eye with central corneal thickness ≥ 670 μm at Visit 1
- Has known severe comorbidities that may interfere with simultaneous cataract surgery and descemetorhexis (including but not limited to a bacterial, viral, or fungal ophthalmic infection)
- Has any clinically significant ocular condition, other than FECD, cataract, primary open-angle glaucoma* or dry eye in the study eye that requires medication or ocular surgery
- Has diabetes with poor blood sugar control, defined as hemoglobin A1c (HbA1c) value >8.5% at Visit 1
- Has used either collagen shield or contact lenses in either one eye or both eyes within 7 days of Visit 1
See the full eligibility criteria
Who can join
- Is at least 18 years old at the screening visit (Visit 1)
- Has a diagnosis of FECD at Visit 1
- Has confluent central guttae in the study eye that can be removed by descemetorhexis of a circular area of 5.5 mm diameter or less (at Visit 1)
- Study eye with BCVA of 75 letters or fewer by ETDRS testing (Snellen equivalent of 20/32 or worse) at Visit 1
- Has a visually significant cataract in the study eye at Visit 1
- Can understand the written informed consent, provides signed and witnessed written informed consent, and agrees to comply with protocol requirements before any study-specific assessments are performed.
- The study eye descemetorhexis at Visit 2 is confirmed to have excised a central area with confluent guttae and a diameter of 4.5 to 5.5 mm.
- Completion of cataract surgery and with the following conditions: a. Intraocular lens placement in the capsular bag without complications (eg, broken posterior capsule, need for anterior vitrectomy). b. Absence of Descemet membrane stripping or detachment outside the central zone (a small area of detachment or stripping may occur adjacent to the phaco wound and is acceptable if ≤0.5mm surface area). c. Confirmation via the operating microscope that the intraocular lens is in the correct location in the capsular bag. d. No AE noted by the surgeon during the surgery.
What rules you out
- Is a female subject of childbearing potential and any of the following is true: a. is pregnant or lactating/breastfeeding, or b. is not surgically sterile, not post-menopausal (no menses for the previous 12 months), or not practicing an effective method of birth control as determined by the Investigator (eg, oral contraceptives, double barrier methods, hormonal injectable or implanted contraceptives, tubal ligation, or partner with vasectomy)
- Has a study eye with central corneal thickness ≥ 670 μm at Visit 1
- Has known severe comorbidities that may interfere with simultaneous cataract surgery and descemetorhexis (including but not limited to a bacterial, viral, or fungal ophthalmic infection)
- Has any clinically significant ocular condition, other than FECD, cataract, primary open-angle glaucoma* or dry eye in the study eye that requires medication or ocular surgery
- Has diabetes with poor blood sugar control, defined as hemoglobin A1c (HbA1c) value >8.5% at Visit 1
- Has used either collagen shield or contact lenses in either one eye or both eyes within 7 days of Visit 1
- Is unwilling to stop use of either collagen shield or contact lenses for the duration of the study
- Has hypersensitivity to any ophthalmic medication used for diagnosis or treatment, including eye drops containing antibiotic(s) or glucocorticoid(s)
- Has known hypersensitivity to any component of the study drugs
- Has previously used ripasudil
- Has used netarsudil or eye drops and ointments containing ≥2% sodium chloride within 14 days prior to Visit 1
- Has a study eye with confluent guttae in the periphery or confluent guttae outside the stripped area (individual guttae are allowed) after simultaneous cataract surgery and descemetorhexis
- Has partecipated in any investigational drug or device clinical studies within 30 days of Visit 1 or is planning to participate in any investigational drug or device clinical studies during the study period
- Has a positive urine test result for drugs of abuse (opiates, methadone, cocaine, amphetamines, barbiturates, or benzodiazepines) or alcohol at screening; however, drugs prescribed to treat current medical conditions are allowed
- Is a member or a family member of the professional or ancillary personnel working at the study site or the Sponsor involved in the study
- Has a concomitant medical or psychological condition that could interfere with study participation or is otherwise not suitable for entry into the study in the opinion of the Investigator
- Is using any prohibited prescription or over-the-counter (OTC) medications or devices and is unwilling or unable to discontinue these medications or devices for the required time period before entry into the study
- Is committed to an institution by virtue of an order issued either by the judicial or the administrative authorities
- Has any ocular disease that may affect visual acuity in the study eye, such as glaucoma that has progressed to the central visual field, age-related macular degeneration, diabetic macular edema, amblyopia, etc
- Has had capsular rupture or infection in the study eye or any other complications or AEs during cataract surgery.
- Has a study eye with baseline (pre-DSO) peripheral ECD ungradable for any area (nasal, temporal, superior, and inferior) due to any reason other than a medical reason (eg, guttae, corneal edema, or striae)
- Has a study eye with a history of any previous intraocular surgery other than for cataract prior to Visit 1
- Has a non-study eye with a history of any previous intraocular surgery within 30 days of Visit 1
- Plans to receive any surgical treatment on the study eye, other than the study simultaneous cataract surgery and descemetorhexis, during the duration of the study
- Plans to receive any surgical treatment for FECD or cataract on the non-study eye during either the screening or treatment period
- Has advanced corneal stromal edema, which is defined as the presence of widespread haze or bullae on slit lamp examination at Visits 1 and 2
The study team makes the final eligibility decision.
Where it's taking place
- United States
- United Kingdom
- Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; United Kingdom; Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.