NCT05063734

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

A Phase 2, Randomised, Multicentre Study to Assess the Dose Level of Multiple THR-687 Injections and to Evaluate the Efficacy and Safety of THR-687 Versus Aflibercept for the Treatment of Diabetic Macular Oedema (DME)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Oxurion · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

In Part A, approximately 12 subjects are planned to be randomized (1:1 allocation) to THR-687 1.2mg and THR-687 2.0mg. In Part B, in the cohort of Treatment Naïve subjects are planned to be randomized (2:1 allocation) to THR-687 selected dose level from Part A and Aflibercept 2.0mg. In Part B, in the cohort of Previously Treated subjects are planned to be randomized (1:1 allocation) to THR-687 selected dose level from Part A and Aflibercept 2.0mg. All subjects in the study will receive study treatment in one selected study eye only.

Conditions

• Diabetes Mellitus
• Diabetic Retinopathy
• Diabetic Macular Edema

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-08-27
• Primary completion: 2022-06-29
• Completion: 2022-06-29
• First posted: 2021-10-01
• Last updated: 2023-08-18
• Results posted: 2023-08-18

Locations

25 sites across 5 countries: United States, Estonia, Hungary, Latvia, Lithuania

Regulatory

• FDA-regulated drug study