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A Study to Evaluate the Safety and Efficacy of THR-317 for the Treatment of Diabetic Macular Oedema (DME)

NCT03071068 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2018-04-17

No results posted yet for this study

Summary

This study is conducted to evaluate the safety of THR-317 when administered intravitreally and to assess the compound's efficacy in improving best-corrected visual acuity (BCVA) and reducing central subfield thickness (CST) in subjects with centre-involved diabetic macular oedema (DME).

Conditions

Interventions

DRUG

Anti-PlGF recombinant monoclonal antibody, 4mg dose

3 intravitreal injections of THR-317 4mg approximately 1 month apart

DRUG

Anti-PlGF recombinant monoclonal antibody, 8mg dose

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

Sponsors & Collaborators

  • ThromboGenics

    lead INDUSTRY

Principal Investigators

  • Clinical Department · ThromboGenics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-22
Primary Completion
2018-04-30
Completion
2018-04-30

Countries

  • Czechia
  • Hungary
  • Slovakia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03071068 on ClinicalTrials.gov