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

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

Official Title
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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)

Conditions
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Diabetes Mellitus, Diabetic Retinopathy, Diabetic Macular Edema

Intervention / Treatment
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* Drug: THR-149 dose level 1
* Drug: THR-149 dose level 2
* Drug: THR-149 dose level 3


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: THR-149 dose level 1<br> | Drug: THR-149 dose level 1<br>* single intravitreal injection of THR-149 dose level 1<br>|
| Experimental: THR-149 dose level 2<br> | Drug: THR-149 dose level 2<br>* single intravitreal injection of THR-149 dose level 2<br>|
| Experimental: THR-149 dose level 3<br> | Drug: THR-149 dose level 3<br>* single intravitreal injection of THR-149 dose level 3<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of dose-limiting toxicities up to the Day 14 visit |  | up to Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |