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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
3 intravitreal injections of THR-317 8mg, approximately 1 month apart
Hôpital Lariboisière
Paris, France
Hôpital Cochin
Paris, France
Hôpital Ophtalmique Jules-Gonin
Lausanne, Switzerland
Change from baseline in central subfield thickness (CST), based on spectral domain optical coherence tomography (SD-OCT)
Time frame: At Day 84 (Month 3)
Change from baseline in CST, based on SD-OCT, by study visit
Time frame: From baseline to Day 140
Change from baseline in area of cystoid spaces, based on SD-OCT, by study visit
Time frame: From baseline to Day 140
Change from baseline in best-corrected visual acuity (BCVA), by study visit
Time frame: From Day 0 to Day 140
Incidence of systemic and ocular adverse events including serious adverse events
Time frame: From Day 0 to Day 140
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