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

September 1, 2020 updated by: ThromboGenics

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)

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75010
        • Hôpital Lariboisière
      • Paris, France, 75181
        • Hopital Cochin
  • Switzerland
      • Lausanne, Switzerland, 1000
        • Hôpital ophtalmique Jules-Gonin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: THR-317
Drug: THR-317 8mg
3 intravitreal injections of THR-317 8mg, approximately 1 month apart

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in CST, based on SD-OCT, by study visit
Time Frame: From baseline to Day 140
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
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
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
From Day 0 to Day 140

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ThromboGenics

Investigators

  • Study Director: Clinical Department, Oxurion NV.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 18, 2018

Primary Completion (Actual)

November 22, 2019

Study Completion (Actual)

November 22, 2019

Study Registration Dates

First Submitted

September 10, 2018

First Submitted That Met QC Criteria

September 11, 2018

First Posted (Actual)

September 13, 2018

Study Record Updates

Last Update Posted (Actual)

September 2, 2020

Last Update Submitted That Met QC Criteria

September 1, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • THR-317-003
  • 2017-004010-26 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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