Overview

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

Status:
Completed
Trial end date:
2019-11-22
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
ThromboGenics
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