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Completed

NCT Number: NCT03669393

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

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).

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Key information

Conditions

Retinal Telangiectasis Cardiovascular Diseases Eye Diseases Idiopathic Juxtafoveal Retinal Telangiectasia Retinal Diseases Telangiectasis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hôpital Cochin, Paris, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

THR-317 8mg

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

ThromboGenics

Industry

Registry information

Official study 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)

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 13, 2018
Registry last updated
Sep 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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