A Study to Evaluate the Safety of THR-149 in Subjects With Diabetic Macular Edema (DME)

A Phase 1, Open-label, Multicenter, Dose Escalation Study to Evaluate the Safety of a Single Intravitreal Injection of THR-149 for the Treatment of Diabetic Macular Edema (DME)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03511898

Enrollment

Registered

2018-04-30

Start date

2018-05-18

Completion date

2019-05-22

Last updated

2019-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Diabetic Macular Edema, Diabetic Retinopathy

Brief summary

This study is conducted to evaluate the safety of a single intravitreal injection of THR-149.

Interventions

DRUGTHR-149 dose level 1

single intravitreal injection of THR-149 dose level 1

DRUGTHR-149 dose level 2

single intravitreal injection of THR-149 dose level 2

DRUGTHR-149 dose level 3

single intravitreal injection of THR-149 dose level 3

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Male or female aged 18 years or older * Type 1 or type 2 Diabetes Mellitus * Central-involved DME with central subfield thickness of ≥ 320µm on Spectralis® spectral domain optical coherence tomography (SD-OCT) or ≥ 305µm on non-Spectralis SD-OCT, in the study eye * Best-corrected visual acuity (BCVA) ≤ 62 and ≥ 23 ETDRS letter score in the study eye * Written informed consent obtained from the subject prior to screening procedures

Exclusion criteria

* Macular edema due to causes other than DME * Concurrent disease in the study eye, other than central-involved DME, that could compromise BCVA, require medical or surgical intervention during the study period or could confound interpretation of the results * Any condition that could confound the ability to detect a change in central subfield thickness in the study eye * Previous confounding treatments / procedures, or their planned / expected use during the study period * Presence of neovascularization at the disc (NVD) in the study eye * Uncontrolled glaucoma in the study eye * Any active ocular / intra-ocular infection or inflammation in either eye * Poorly controlled Diabetes Mellitus * Uncontrolled hypertension

Design outcomes

Primary

Measure	Time frame
Incidence of dose-limiting toxicities up to the Day 14 visit	up to Day 14

Secondary

Measure	Time frame
Incidence of systemic and ocular adverse events including serious adverse events up to the end of the study	From Day 0 up to Day 84
Occurrence of laboratory abnormalities up to the end of the study	At Screening, Day 1, Day 7, Day 28 and Day 84

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026