THR-149 selected dose level for Diabetic Macular Edema

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Diabetic Macular Edema+2 MoreTHR-149 selected dose level - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is to study the effects of a new drug, THR-149, on patients with macular degeneration. Part A is to select the dose, and Part B is to compare the new drug to aflibercept, which is the current standard of care.

Eligible Conditions
  • Diabetic Macular Edema
  • Diabetes
  • Diabetic Retinopathy

Treatment Effectiveness

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Up to Month 6

At Month 3
Mean change in best-corrected visual acuity (BCVA) ETDRS letter score from Baseline, in subjects in Part B of the study
Up to Month 6
Incidence of systemic and ocular adverse events (AEs) and serious adverse events (SAEs)
Mean change in BCVA ETDRS letter score from Baseline, by study visit
Mean change in central subfield thickness (CST) from Baseline, by study visit

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

9 Treatment Groups

aflibercept
1 of 9
Aflibercept + THR-149 flip-over
1 of 9
Aflibercept + sham
1 of 9
THR-149 dose level 1
1 of 9
THR-149 selected dose level
1 of 9
THR-149 + sham
1 of 9
THR-149 dose level 2
1 of 9
THR-149 dose level 3
1 of 9
THR-149 + aflibercept flip-over
1 of 9

Active Control

Experimental Treatment

126 Total Participants · 9 Treatment Groups

Primary Treatment: THR-149 selected dose level · No Placebo Group · Phase 2

THR-149 dose level 1
Drug
Experimental Group · 1 Intervention: THR-149 dose level 1 · Intervention Types: Drug
THR-149 selected dose level
Drug
Experimental Group · 1 Intervention: THR-149 selected dose level · Intervention Types: Drug
THR-149 + sham
Drug
Experimental Group · 1 Intervention: THR-149 0.13mg · Intervention Types: Drug
THR-149 dose level 2
Drug
Experimental Group · 1 Intervention: THR-149 dose level 2 · Intervention Types: Drug
THR-149 dose level 3
Drug
Experimental Group · 1 Intervention: THR-149 dose level 3 · Intervention Types: Drug
THR-149 + aflibercept flip-over
Drug
Experimental Group · 1 Intervention: THR-149 0.13mg + aflibercept 2mg · Intervention Types: Drug
aflibercept
Drug
ActiveComparator Group · 1 Intervention: Aflibercept · Intervention Types: Drug
Aflibercept + THR-149 flip-over
Drug
ActiveComparator Group · 1 Intervention: aflibercept 2mg + THR-149 0.13mg · Intervention Types: Drug
Aflibercept + sham
Drug
ActiveComparator Group · 1 Intervention: Aflibercept 2mg · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
THR-149 dose level 3
2018
Completed Phase 1
~20
THR-149 dose level 1
2018
Completed Phase 1
~20
THR-149 dose level 2
2018
Completed Phase 1
~20

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to month 6

Who is running the clinical trial?

OxurionLead Sponsor
4 Previous Clinical Trials
616 Total Patients Enrolled
Clinical DepartmentStudy DirectorOxurion
9 Previous Clinical Trials
248 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have received 5 or more anti-VEGF injections for the treatment of CI-DME.
You have type 1 or type 2 diabetes.
Patient BCVA ≤ 73 and ≥ 39 in the study eye (for subjects in Part A); Patient BCVA ≤ 73 and ≥ 24 in the study eye (for subjects in Part B).
You are male or female aged 18 years or older at the time of signing the informed consent.