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

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)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03669393

Enrollment

Registered

2018-09-13

Start date

2018-09-18

Completion date

2019-11-22

Last updated

2020-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Juxtafoveal Retinal Telangiectasia, Retinal Telangiectasis

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).

Interventions

DRUGTHR-317 8mg

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

France, Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026