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)

Sponsors

Lead Sponsor: ThromboGenics

Source Oxurion
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).

Overall Status Completed
Start Date September 18, 2018
Completion Date November 22, 2019
Primary Completion Date November 22, 2019
Phase Phase 2
Study Type Interventional
Primary Outcome
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 Outcome
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
Enrollment 8
Condition
Intervention

Intervention Type: Drug

Intervention Name: THR-317 8mg

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

Arm Group Label: THR-317

Eligibility

Criteria:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Clinical Department Study Director Oxurion NV.
Location
Facility:
Hôpital Lariboisière | Paris, 75010, France
Hôpital Cochin | Paris, 75181, France
Hôpital Ophtalmique Jules-Gonin | Lausanne, 1000, Switzerland
Location Countries

France

Switzerland

Verification Date

September 2020

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: THR-317

Type: Experimental

Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov