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

ThromboGenics

Status and phase: Completed; Phase 2

Conditions: Retinal Telangiectasis; Idiopathic Juxtafoveal Retinal Telangiectasia

Treatments: Drug: THR-317 8mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT03669393

THR-317-003

2017-004010-26 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

8 participants in 1 patient group

THR-317

Experimental group

Treatment:

Drug: THR-317 8mg