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

ThromboGenics

Status and phase

Completed

Phase 1

Conditions

Diabetic Macular Edema

Diabetes Mellitus

Diabetic Retinopathy

Treatments

Drug: THR-149 dose level 3

Drug: THR-149 dose level 2

Drug: THR-149 dose level 1

Study type

Interventional

Funder types

Industry

Identifiers

THR-149-001

Details and patient eligibility

About

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

Enrollment

12 patients

Sex

All

Ages

18+ years old

Volunteers

No 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