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Clinical trials for Keratoplasty

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
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • 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   44339   clinical trials with a EudraCT protocol, of which   7369   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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    8 result(s) found for: Keratoplasty. Displaying page 1 of 1.
    EudraCT Number: 2007-000294-33 Sponsor Protocol Number: LX201-02 Start Date*: 2007-07-27
    Sponsor Name:Lux Biosciences, Inc.
    Full Title: A MULTI-CENTER, PLACEBO-CONTROLLED, RANDOMIZED, PARALLEL-GROUP, DOSE-RANGING STUDY TO ASSESS THE EFFICACY AND SAFETY OF LX201 IMPLANTATION FOR THE PREVENTION OF CORNEAL ALLOGRAFT REJECTION EPISODES...
    Medical condition: Patient after penetrating keratoplasty who have experienced one or more rejection episodes
    Disease: Version SOC Term Classification Code Term Level
    9.1 10011017 Corneal graft rejection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2007-000295-16 Sponsor Protocol Number: LX201-01 Start Date*: 2007-07-27
    Sponsor Name:Lux Biosciences, Inc.
    Full Title: A MULTI-CENTER, PLACEBO-CONTROLLED, RANDOMIZED, PARALLEL-GROUP DOSE-RANGING STUDY TO ASSESS THE EFFICACY AND SAFETY OF LX201 FOR PREVENTION OF CORNEAL ALLOGRAFT REJECTION EPISODES AND GRAFT FAILURE...
    Medical condition: Patient after penetrating keratoplasty who are at increased immunological risk for corneal allograft rejection episodes and/or graft failure
    Disease: Version SOC Term Classification Code Term Level
    9.1 10011017 Corneal graft rejection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (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)
    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 (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2015-001344-11 Sponsor Protocol Number: CCD-GPLSCD01-03-FU Start Date*: 2018-04-11
    Sponsor Name:Chiesi Farmaceutici S.p.A.
    Full Title: Multinational, multicenter, prospective, long-term safety and efficacy follow-up study after Autologous Cultivated Limbal Stem Cells Transplantation (ACLSCT) for restoration of corneal epithelium i...
    Medical condition: corneal lesions with associated moderate to severe limbal stem cell deficiency due to ocular burns
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004853 10011012 Corneal epithelium opacity LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) PL (Completed) FR (Completed) DE (Completed) GB (GB - no longer in EU/EEA) ES (Ongoing) NL (Ongoing) IT (Completed)
    Trial results: View results
    EudraCT Number: 2010-024290-40 Sponsor Protocol Number: CAH/Ulc/2010 Start Date*: 2012-12-04
    Sponsor Name:FUNDACIÓN PROGRESO Y SALUD
    Full Title: Multicenter clinical trial to evaluate the safety and feasibility of allogeneic tissue engineered product (human nanostructured artificial cornea) in patients with advanced corneal trophic ulcers r...
    Medical condition: trophic corneal ulcers refractaries to conventional treatment
    Disease: Version SOC Term Classification Code Term Level
    14.1 10015919 - Eye disorders 10048492 Corneal ulcer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: View results
    EudraCT Number: 2013-004247-24 Sponsor Protocol Number: CCRG13-003 Start Date*: 2015-01-27
    Sponsor Name:Antwerp University Hospital (UZA)
    Full Title: Translational stem cell research in ophthalmology - regenerating the anterior cornea through standardized transplantation of limbal epithelial stem cells: a phase II multicenter trial
    Medical condition: Primary and secondary Limbal Stem Cell Deficiencies
    Disease: Version SOC Term Classification Code Term Level
    17.1 10042613 - Surgical and medical procedures 10069798 Amniotic membrane graft PT
    17.1 10015919 - Eye disorders 10072138 Limbal stem cell deficiency PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-001823-30 Sponsor Protocol Number: 043/SI Start Date*: 2017-06-12
    Sponsor Name:SIFI SpA
    Full Title: Randomized, Assessor-Masked, Active-Controlled, Phase 3 Study to Evaluate Efficacy, Safety and Tolerability of 0.08% Polyhexamethylene Biguanide (PHMB) Ophthalmic Solution in Comparison with 0.02% ...
    Medical condition: Acanthamoeba keratitis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10069408 Acanthamoeba keratitis PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) PL (Completed) IT (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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