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Clinical trials for Fuchs' dystrophy

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   44294   clinical trials with a EudraCT protocol, of which   7351   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    6 result(s) found for: Fuchs' dystrophy. Displaying page 1 of 1.
    EudraCT Number: 2017-002490-19 Sponsor Protocol Number: UKER-FECD-RIPA-01 Start Date*: 2017-12-07
    Sponsor Name:Universitätsklinikum Erlangen
    Full Title: Prospective single-centre randomized observer-blind placebo-controlled parallel-group phase IIa clinical trial to investigate the safety and efficacy of ripasudil 0.4% eye drops after descemetorhex...
    Medical condition: Moderate to advanced Fuchs endothalial corneal dystrophy (FECD)
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004850 10062973 Fuchs' endothelial dystrophy LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-006456-14 Sponsor Protocol Number: K321301 Start Date*: 2023-05-10
    Sponsor Name:Kowa Research Institute, Inc.
    Full Title: A Double-Masked, Randomized, Placebo-Controlled, Parallel-Group, 12-Week Administration With Two-Week Gradual Dose Taper Phase and 38-Week Follow-Up Phase, Phase 3 Study to Investigate the Safety ...
    Medical condition: In Fuchs endothelial corneal dystrophy (FECD), there is an increased rate of loss of endothelial cells, starting in the centre of Descemet’s membrane and spreading to the periphery, resulting in ex...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10011005 Corneal dystrophy PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Ongoing) DK (Trial now transitioned) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-003280-22 Sponsor Protocol Number: K-321-201 Start Date*: 2020-04-29
    Sponsor Name:Kowa Research Institute, Inc.
    Full Title: A Double-Masked, Randomised, Placebo-Controlled, Parallel-Group, 12-Week, Phase 2 Study to Investigate the Safety and Efficacy of Ripasudil (K-321) Eye Drops After Descemetorhexis in Patients wit...
    Medical condition: In Fuchs endothelial corneal dystrophy (FECD), there is an increased rate of loss of endothelial cells, starting in the centre of Descemet’s membrane and spreading to the periphery, resulting in ex...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10011005 Corneal dystrophy PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2022-000174-25 Sponsor Protocol Number: 101090401IN Start Date*: 2023-03-17
    Sponsor Name:SANTEN INCORPORATED
    Full Title: A Phase IIa, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group, Multicenter Study Assessing the Efficacy and Safety of STN1010904 Ophthalmic Suspension 0.03% and 0.1% Compared with Vehi...
    Medical condition: Fuchs Endothelial Corneal Dystrophy (FECD)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10014823 Endothelial corneal dystrophy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2007-005274-31 Sponsor Protocol Number: 2380/2007 Start Date*: 2008-12-02
    Sponsor Name:AZIENDA OSPEDALIERA PISANA
    Full Title: Efficacy assessment of tetracycline in patients with progressive external ophthalmoplegia.
    Medical condition: Progressive external ophthalmoplegia.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10036802 Progressive external ophthalmoplegia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2005-002389-13 Sponsor Protocol Number: Start Date*: 2005-11-23
    Sponsor Name:Moorfields Eye Hospital
    Full Title: Endothelial Lamellar Keratoplasty (ELK) with Tisseel adhesive.
    Medical condition: Corneal endothelial failure, from Fuchs' corneal endothelial dystrophy, aphakic and pseudophakic bullous keratopathy and other causes.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: (No results available)
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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