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

Phase 2

Completed

• Conditions: Retinal Telangiectasis; Idiopathic Juxtafoveal Retinal Telangiectasia
• Interventions: Drug: THR-317 8mg

• Registration Number: NCT03669393
• Lead Sponsor: ThromboGenics

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-10
• Study First Submitted QC: 2018-09-11
• Study First Posted: 2018-09-13
• Study Start: 2018-09-18
• Primary Completion: 2019-11-22
• Study Completion: 2019-11-22
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-01
• Last Update Posted: 2020-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
THR-317	THR-317 8mg	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Hôpital Lariboisière; 🇫🇷 Paris, France

Hôpital Cochin; 🇫🇷 Paris, France

Hôpital Ophtalmique Jules-Gonin; 🇨🇭 Lausanne, Switzerland