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NCT03249337 · ClinicalTrials.gov registry record · Phase 4
Glanatec(R) for Descemet Stripping in Fuch's Endothelial Dystrophy
A Phase 4 study of Fuchs Endothelial Dystrophy, sponsored by Marian Macsai, MD.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT03249337 is a Phase 4 study of Fuchs Endothelial Dystrophy that is actively recruiting participants, run by Marian Macsai, MD. The registered enrollment target is 30 participants, below the 493-participant average among 7 other Fuchs Endothelial Dystrophy trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03249337, a Phase 4 study of Fuchs Endothelial Dystrophy, is actively recruiting participants, sponsored by Marian Macsai, MD.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
In brief, the objective of this study is to investigate whether the drug Glanatec ® which is approved in Japan for glaucoma and ocular hypertension, can be used in patients with Fuchs endothelial dystrophy who have had a descemet stripping procedure without endothelial keratoplasty. While some limited data exists as a proof of concept in in vitro or animal studies, and Glanatec® has been successfully used in a recently published case series for this indication, there is insufficient data to show that this drug can be effectively used for corneal cell clearing while maintaining patient safety. The goal of the study is to provide sufficient proof of concept for the use of this drug in patients with FED whose only treatment alternative is to undergo corneal transplant.
Conditions Studied
Interventions
- DRUG Ripasudil hydrochloride hydrate 0.4% ophthalmic solution
Study Locations (1)
Illinois
- NorthShore University HealthSystem - Glenview
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2017-12-06 |
| Est. Completion | 2021-12 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03249337
The ClinicalTrials.gov registry entry for NCT03249337 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 493-participant average among 7 other Fuchs Endothelial Dystrophy trials with a reported enrollment target (94% lower). The listed sponsor is Marian Macsai, MD, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Fuchs Endothelial Dystrophy appearing as the primary indexed condition, and to 1 intervention - of which Ripasudil hydrochloride hydrate 0.4% ophthalmic solution is the first listed.
NCT03249337 reports 1 study location spanning 1 distinct geographic area - top geographies include Illinois.
Frequently Asked Questions
What is clinical trial NCT03249337 about?
NCT03249337 is a clinical study titled "Glanatec(R) for Descemet Stripping in Fuch's Endothelial Dystrophy". In brief, the objective of this study is to investigate whether the drug Glanatec ® which is approved in Japan for glaucoma and ocular hypertension, can be used in patients with Fuchs endothelial dystrophy who have had a descemet stripping procedure without endothelial keratoplasty. While some limit...
What is the current status of trial NCT03249337?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 30 participants. The study started on 2017-12-06. Estimated completion is 2021-12.
What conditions does trial NCT03249337 study?
This clinical trial studies the following conditions: Fuchs Endothelial Dystrophy.
What interventions are being tested in trial NCT03249337?
The interventions under investigation include: Ripasudil hydrochloride hydrate 0.4% ophthalmic solution (DRUG).
Who is sponsoring clinical trial NCT03249337?
This trial is sponsored by Marian Macsai, MD, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03249337 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Read our methodology - how this data is sourced, computed, and verified.
Related
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