A Study to Evaluate THR-317 and Ranibizumab Combination Treatment for Diabetic Macular Oedema (DME)

Sponsor
Oxurion
Study ID
NCT03499223
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ranibizumab 0.5mg — DRUG
    3 intravitreal injections of ranibizumab 0.5mg, approximately 1 month apart
  • THR-317 8mg — DRUG
    3 intravitreal injections of THR-317 8mg, approximately 1 month apart
  • Sham injection — DRUG
    3 sham injections, approximately 1 month apart. No actual injections. No medication is used.

Study Details

This study is conducted to evaluate the safety of intravitreal THR-317 administered in combination with ranibizumab, and to assess the efficacy of the combination treatment in improving best-corrected visual acuity (BCVA) and reducing central subfield thickness (CST), in subjects with central-involved diabetic macular oedema (CI-DME).

Key Dates

First listed
Apr 17, 2018
Start date
Apr 20, 2018
Status verified
Aug 2019
Primary completion
Jul 18, 2019
Completion
Jul 18, 2019

Study Design

Enrollment
70 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ranibizumab + THR-317
    Subjects will receive intravitreal ranibizumab in combination with THR-317
  • Active Comparator: Sham + ranibizumab
    Subjects will receive a sham injection in combination with intravitreal ranibizumab

Primary Outcome Measure

Change from baseline in BCVA [ Time Frame: At Day 84 (Month 3) ]

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