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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: Recruiting Phase 4 study of Fuchs Endothelial Dystrophy, sponsored by Marian Macsai, MD.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The first primary aim of this study is to examine whether Glanatec® administered three or six times daily significantly increases corneal clearing at 12 months versus baseline in patients with Fuchs endothelial dystrophy (FED) undergoing Descemet stripping
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 |
What NCT03249337 shows while recruiting
NCT03249337 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 493-participant average among 7 other Fuchs Endothelial Dystrophy trials with a reported enrollment target (94% lower).
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 a single indexed study location in 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.
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