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A Study to Evaluate THR-317 Treatment for Macular Telangiectasia Type 1 (MacTel 1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03669393
Recruitment Status : Completed
First Posted : September 13, 2018
Last Update Posted : September 2, 2020
Sponsor:
Information provided by (Responsible Party):
Oxurion ( ThromboGenics )

Study Description
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Brief Summary:
This study is conducted to evaluate the safety of THR-317 when administered intravitreally and to assess the compound's efficacy in reducing central subfield thickness (CST) and improving best-corrected visual acuity (BCVA) in subjects with macular telangiectasia Type 1 (MacTel 1).

Condition or disease Intervention/treatment Phase
Retinal Telangiectasis Idiopathic Juxtafoveal Retinal Telangiectasia Drug: THR-317 8mg Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Open-label, Multi-centre Study to Assess the Efficacy and Safety of Intravitreal THR-317 for the Treatment of Macular Telangiectasia Type 1 (MacTel 1)
Actual Study Start Date : September 18, 2018
Actual Primary Completion Date : November 22, 2019
Actual Study Completion Date : November 22, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: THR-317 Drug: THR-317 8mg
3 intravitreal injections of THR-317 8mg, approximately 1 month apart


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in central subfield thickness (CST), based on spectral domain optical coherence tomography (SD-OCT) [ Time Frame: At Day 84 (Month 3) ]

Secondary Outcome Measures :
  1. Change from baseline in CST, based on SD-OCT, by study visit [ Time Frame: From baseline to Day 140 ]
  2. Change from baseline in area of cystoid spaces, based on SD-OCT, by study visit [ Time Frame: From baseline to Day 140 ]
  3. Change from baseline in best-corrected visual acuity (BCVA), by study visit [ Time Frame: From Day 0 to Day 140 ]
  4. Incidence of systemic and ocular adverse events including serious adverse events [ Time Frame: From Day 0 to Day 140 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female aged 18 years or older
  • Macular oedema caused by MacTel 1, with CST >300µm on SD-OCT
  • Written informed consent obtained from the subject prior to screening procedures

Exclusion Criteria:

  • Type 1 or type 2 Diabetes Mellitus
  • Concurrent disease in the study eye that could require medical or surgical intervention during the study period for up to 30 days after the last study treatment, or could confound interpretation of the results
  • Previous confounding treatments / procedures, or their planned / expected use during the study period for up to 30 days after the last administration of study treatment
  • Any active ocular / intraocular infection or inflammation in either eye
  • Pregnant or lactating female, or female of child-bearing potential not utilising an adequate form of contraception, or male of reproductive potential not utilising contraception
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03669393


Locations
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France
Hôpital Lariboisière
Paris, France, 75010
Hôpital Cochin
Paris, France, 75181
Switzerland
Hôpital Ophtalmique Jules-Gonin
Lausanne, Switzerland, 1000
Sponsors and Collaborators
ThromboGenics
Investigators
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Study Director: Clinical Department Oxurion NV.
More Information
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Responsible Party: ThromboGenics
ClinicalTrials.gov Identifier: NCT03669393    
Other Study ID Numbers: THR-317-003
2017-004010-26 ( EudraCT Number )
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: September 2, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Retinal Telangiectasis
Telangiectasis
Vascular Diseases
 Cardiovascular Diseases
Retinal Diseases
Eye Diseases