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

NCT ID: NCT03669393

Last Updated: 2020-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-18
• Study Completion Date: 2019-11-22

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).

Conditions

Retinal Telangiectasis; Idiopathic Juxtafoveal Retinal Telangiectasia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

THR-317

Group Type: EXPERIMENTAL

THR-317 8mg

Intervention Type: DRUG

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

Interventions

THR-317 8mg

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ThromboGenics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Department

Role: STUDY_DIRECTOR

Oxurion NV.

Locations

Hôpital Lariboisière

Paris, , France

Hôpital Cochin

Paris, , France

Hôpital Ophtalmique Jules-Gonin

Lausanne, , Switzerland

Countries

France; Switzerland

Other Identifiers

2017-004010-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

THR-317-003

Identifier Type: -

Identifier Source: org_study_id