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A Study to Evaluate THR-687 Treatment for Diabetic Macular Oedema.

NCT05063734 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2023-08-18

Study results available
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Summary

This study is conducted to select the THR-687 dose level (Part A of the study) and to assess the efficacy and safety of the selected dose level compared to aflibercept (Part B of the study).

Conditions

Interventions

DRUG

THR-687 dose level 1

3 intravitreal injections of THR-687 dose level 1, 1 month apart

DRUG

THR-687 dose level 2

3 intravitreal injections of THR-687 dose level 2, 1 month apart

DRUG

THR-687 selected dose level

3 intravitreal injections of THR-687 selected dose level, 1 month apart, possibly followed by a 4th intravitreal injection with the same dose level of THR-687 at Month 3, or Month 4, or Month 5, if any of the PRN criteria are met.

DRUG

Aflibercept

3 intravitreal injections of aflibercept, 1 month apart, possibly followed by a 4th intravitreal injection with aflibercept at Month 3, or Month 4, or Month 5, if any of the PRN criteria are met.

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
2021-08-27
Primary Completion
2022-06-29
Completion
2022-06-29
FDA Drug
Yes

Countries

  • United States
  • Estonia
  • Hungary
  • Latvia
  • Lithuania

Study Locations

More Related Trials

Entities

Drugs
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 NCT05063734 on ClinicalTrials.gov