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

Retinal Telangiectasis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03669393
• Other study ID #: THR-317-003
• Secondary ID: 2017-004010-26
• Status: Completed
• Phase: Phase 2
• Start date: September 18, 2018
• Est. completion date: November 22, 2019

Study information

• Verified date: September 2020
• Source: Oxurion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: November 22, 2019
• Est. primary completion date: November 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Idiopathic Juxtafoveal Retinal Telangiectasia
• Retinal Telangiectasis
• Telangiectasis

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Cochin	Paris
France	Hôpital Lariboisière	Paris
Switzerland	Hôpital Ophtalmique Jules-Gonin	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
ThromboGenics

Countries where clinical trial is conducted

France,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in central subfield thickness (CST), based on spectral domain optical coherence tomography (SD-OCT)		At Day 84 (Month 3)
Secondary	Change from baseline in CST, based on SD-OCT, by study visit		From baseline to Day 140
Secondary	Change from baseline in area of cystoid spaces, based on SD-OCT, by study visit		From baseline to Day 140
Secondary	Change from baseline in best-corrected visual acuity (BCVA), by study visit		From Day 0 to Day 140
Secondary	Incidence of systemic and ocular adverse events including serious adverse events		From Day 0 to Day 140