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A Study to Evaluate THR-149 Treatment for Diabetic Macular Oedema

NCT04527107 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2023-11-27

No results posted yet for this study

Summary

Part A of the study is conducted to select the THR-149 dose level.

Part B of the study is conducted to assess the efficacy and safety of the selected dose level compared to aflibercept, up to Month 3. As from Month 3, in about half of the subjects, the effect of a single flip-over injection (aflibercept or THR-149) will be evaluated when administered 1 month after the 3 monthly injections of THR-149 or aflibercept. In the other subjects, the durability of 3 monthly injections of THR 149 or aflibercept will be evaluated.

Conditions

Interventions

DRUG

THR-149 dose level 1

3 intravitreal injections of THR-149 dose level 1, 1 month apart

DRUG

THR-149 dose level 2

3 intravitreal injections of THR-149 dose level 2, 1 month apart

DRUG

THR-149 dose level 3

3 intravitreal injections of THR-149 dose level 3, 1 month apart

DRUG

THR-149 0.13mg

3 intravitreal injections of THR-149 0.13mg (selected dose level), 1 month apart, followed after 1 month by a sham (pretend) injection

DRUG

THR-149 0.13mg + aflibercept 2mg

3 intravitreal injections of THR-149 0.13mg (selected dose level), 1 month apart, followed after 1 month by an intravitreal injection of aflibercept 2mg

DRUG

aflibercept 2mg + THR-149 0.13mg

3 intravitreal injections of aflibercept 2mg, 1 month apart, followed after 1 month by an intravitreal injection of THR-149 0.13mg (selected dose level)

DRUG

Aflibercept 2mg

3 intravitreal injections of aflibercept 2mg, 1 month apart, followed after 1 month by a sham (pretend) injection

Sponsors & Collaborators

  • Oxurion

    lead INDUSTRY

Principal Investigators

  • Clinical Department · Oxurion

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-31
Primary Completion
2023-09-28
Completion
2023-11-22
FDA Drug
Yes

Countries

  • United States
  • Czechia
  • France
  • Germany
  • Italy
  • Slovakia
  • Spain
  • 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 NCT04527107 on ClinicalTrials.gov