DT-168 in Keratoplasty Patients With Fuchs Endothelial Corneal Dystrophy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DT-168.
- Who it may be relevant to
- Registry conditions: Fuchs Endothelial Corneal Dystrophy, Fuchs. Basic parameters: from 30 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 2, Multicenter, Open-Label Study to Assess the Pharmacodynamics, Safety, and Tolerability of DT-168 Ophthalmic Solution in Patients With Fuchs Endothelial Corneal Dystrophy Undergoing Keratoplasty
Overview
The purpose of this study is to evaluate the pharmacodynamics, safety, and tolerability of DT-168 Ophthalmic Solution in pre-keratoplasty patients with Fuchs endothelial corneal dystrophy.
Interventions
- Drug DT-168
Active
Primary outcome measures
- FECD Biomarkers: Splicing Panel [Time frame: Perioperative]
Secondary outcome measures (1)
- Safety and Tolerability [Time frame: Through study completion, an average of 4 weeks.]
Eligibility criteria
Inclusion criteria
- Participant is scheduled to undergo a keratoplasty for management of FECD independent of this study.
- ≥30 years of age (inclusive).
- Documented diagnosis of FECD in the study eligible eye.
- Confirmation of positive TCF4 allele 18.1 CTG expansion in at least one allele.
- Capable of giving signed informed consent.
Exclusion criteria
- Any ocular or medical condition in the study eligible eye which is clinically significant or would confound study results or data interpretation.
- Any clinically significant medical, nonmedical, and psychiatric disorders that could put the participant at higher risk for participation in the study, impair the participant's ability to participate in the study, or interfere with interpretation of the participant's study results, in the opinion of the investigator.
- Concurrent or anticipated need for treatment for FECD, eg, Muro 128 (2% or 5%) during the course of the study in the study eye. Provided the subject undergoes a washout of Muro drops for at least 24 hours prior to the Baseline Visit, they will not be excluded.
- Concurrent or anticipated use of topical corticosteroids in the study eye.
- Concurrent use with Rhopressa®, Rocklatan®, or any other ocular Rho Kinase inhibitor.
- Known contraindication, allergy, or hypersensitivity to any of the treatments, anesthetics, or diagnostic agents or components thereof which may be used during the study.
- Use of contact lenses in the study eye within 7 days prior to the Baseline Visit or planned use during the study.
- Recent (within 30 days of the Screening Visit) or ongoing participation in any other investigational interventional clinical study.
- Female participant is pregnant, planning a pregnancy, or breast-feeding.
- Participant is unwilling to comply with the contraceptive requirements, as per protocol.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- DTX-168-201 Study Site — Indianapolis
- DTX-168-201 Study Site — Grand Rapids
Identifiers
NCT: NCT07024693 · DTX-168-201