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

Overview

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).

Full Title of Study: “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)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 22, 2019

Interventions

  • Drug: THR-317 8mg
    • 3 intravitreal injections of THR-317 8mg, approximately 1 month apart

Arms, Groups and Cohorts

  • Experimental: THR-317

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Change from baseline in CST, based on SD-OCT, by study visit
    • Time Frame: From baseline to Day 140
  • Change from baseline in area of cystoid spaces, based on SD-OCT, by study visit
    • Time Frame: From baseline to Day 140
  • Change from baseline in best-corrected visual acuity (BCVA), by study visit
    • Time Frame: From Day 0 to Day 140
  • Incidence of systemic and ocular adverse events including serious adverse events
    • Time Frame: From Day 0 to Day 140

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • ThromboGenics
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Clinical Department, Study Director, Oxurion NV.

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