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

NCT03499223 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2019-08-02

No results posted yet for this study

Summary

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).

Conditions

Interventions

DRUG

Ranibizumab 0.5mg

3 intravitreal injections of ranibizumab 0.5mg, approximately 1 month apart

DRUG

THR-317 8mg

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

DRUG

Sham injection

3 sham injections, approximately 1 month apart. No actual injections. No medication is used.

Sponsors & Collaborators

  • Oxurion

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-20
Primary Completion
2019-07-18
Completion
2019-07-18

Countries

  • Belgium
  • France
  • Germany
  • Slovakia
  • Spain
  • Switzerland
  • United Kingdom

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 NCT03499223 on ClinicalTrials.gov