A Study to Evaluate the Safety of THR-149 in Subjects With Diabetic Macular Edema (DME)
Study Details
Study Description
Brief Summary
This study is conducted to evaluate the safety of a single intravitreal injection of THR-149.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: THR-149 dose level 1
|
Drug: THR-149 dose level 1
single intravitreal injection of THR-149 dose level 1
|
Experimental: THR-149 dose level 2
|
Drug: THR-149 dose level 2
single intravitreal injection of THR-149 dose level 2
|
Experimental: THR-149 dose level 3
|
Drug: THR-149 dose level 3
single intravitreal injection of THR-149 dose level 3
|
Outcome Measures
Primary Outcome Measures
- Incidence of dose-limiting toxicities up to the Day 14 visit [up to Day 14]
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male or female aged 18 years or older
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Type 1 or type 2 Diabetes Mellitus
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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
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Best-corrected visual acuity (BCVA) ≤ 62 and ≥ 23 ETDRS letter score in the study eye
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Written informed consent obtained from the subject prior to screening procedures
Exclusion Criteria:
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Macular edema due to causes other than DME
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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
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Any condition that could confound the ability to detect a change in central subfield thickness in the study eye
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Previous confounding treatments / procedures, or their planned / expected use during the study period
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Presence of neovascularization at the disc (NVD) in the study eye
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Uncontrolled glaucoma in the study eye
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Any active ocular / intra-ocular infection or inflammation in either eye
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Poorly controlled Diabetes Mellitus
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Uncontrolled hypertension
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Retina Consultants of Arizona | Phoenix | Arizona | United States | 85053 |
2 | Ophthalmic Consultants of Boston | Boston | Massachusetts | United States | 02114 |
3 | Sierra Eye Associates | Reno | Nevada | United States | 89502 |
4 | Mid Atlantic Retina | Huntingdon Valley | Pennsylvania | United States | 19006 |
5 | Retina Research Institute of Texas | Abilene | Texas | United States | 79606 |
6 | Retinal Research Center, PLLC | Austin | Texas | United States | 78705 |
7 | Retina Consultants of Houston | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- ThromboGenics
Investigators
- Study Director: Clinical Department, ThromboGenics
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- THR-149-001