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Phase 2a, Random, double masked, Placebo-controlled, side by side group, multiple center study evaluating the effectiveness and safety of STN1010904 Ophthalmic Suspension 0.03% and 0.1% compared with Placebo in Subjects with Fuchs endothelial Corneal Dystrophy (FECD) - PHANTOM Study
EU CTIS ID: 2024-517104-11-00
What this study is testing
Primary Efficacy Objective: - To assess the efficacy of two concentrations of STN1010904 ophthalmic suspension (0.03%, and 0.1 %), twice daily dosing when compared to Placebo in subjects diagnosed with FECD Safety Objective: - To assess the safety of two concentrations of STN1010904 ophthalmic suspension (0.03%, and 0.1 %), twice daily dosing when compared to Placebo in subjects diagnosed with FECD
- Therapeutic exploratory (Phase II)
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
- Subjects are eligible to be included in the study only if all the following criteria are met at Visit 1 (Screening): 1. Male or female, from 30 to 75 years of age, diagnosed with FECD. 2. Provide signed informed consent prior to any study procedures being performed. 3. Best-corrected visual acuity (BCVA) of +0.2 LogMAR or better (equivalent to ≥ 75 ETDRS letters, or at least Snellen 20/32) in the study eye as measured using an ETDRS chart. 4. Grade 3-5 of the Modified Krachmer scale in the study eye.
- 5. At least two out of three tomographic features are observed by Pentacam™, evaluated by the Investigator in the study eye: Tomographic Features: Parameter: Loss of parallel isopachs Definition: Any single isopach not being almost circular/oval or parallel to adjacent isopachs within the central 4 mm of the cornea (relative to the pupil center) Parameter: Displacement of the thinnest point of the cornea Definition: Being located outside of the inferotemporal quadrant (centered at the pupil center) or more than 1 mm from the pupil center in any quadrant. Parameter: Focal posterior corneal depression Definition: Any isolated area of depression (negative elevation relative to a sphere with best fit zone of 8 mm with float function) within the central 4 mm of the cornea (relative to the pupil center)
- 6. Endothelial cells are visible >50% of area in at least one image obtained by noncontact specular microscopy in the central or paracentral-peripheral area in the study eye.
You likely can't join if
- Ocular Conditions: 1. Monocular vision, or vision worse than +0.7 LogMAR (equivalent to < 50 ETDRS letters, or worse than Snellen 20/100) in the fellow eye; 2. No guttae in either eye (evaluated by slit-lamp and specular microscope). 3. Clinically evident stromal and/or epithelial edema in the study eye (evaluated by slit-lamp microscope). 4. Descemet folds in the study eye (evaluated by slit-lamp microscope). 5. Central cornea thickness is 630μm or more in the study eye (evaluated by Scheimpflug image). 6. Moderate/severe cataract in the study eye (mild cataract or pseudophakic eye is eligible for enrolment). 7. Evidence of any other ocular disease other than FECD in the study eye that may confound the outcome of the study (e.g., active diabetic retinopathy, posterior uveitis, age-related macular degeneration or any other maculopathy, severe myopia >10D, pterygium).
- Non-Ocular Conditions: 21. Allergy or hypersensitivity to study drug product, fluorescein dye, or other study related procedures/medications. Current or planned participation in any other clinical study involving an investigational product or device within 4 weeks prior to Visit 1 or at any time during this study. 22. History of any disease or condition that in the opinion of the study investigator may put the subject at significant risk, may confound study results, or may interfere significantly with the subject's participation in the study (e.g., recurrent corneal erosion syndrome, uncontrolled cardiovascular disease etc.).
The study team makes the final eligibility decision.
Where it's taking place
- United States
- India
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; India. 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.