A Study to Evaluate the Safety of THR-687 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-687.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: THR-687 dose level 1 Subjects in this arm will receive a single intravitreal injection of THR-687 dose level 1 |
Drug: THR-687 dose level 1
single intravitreal injection of THR-687 dose level 1
|
Experimental: THR-687 dose level 2 Subjects in this arm will receive a single intravitreal injection of THR-687 dose level 2 |
Drug: THR-687 dose level 2
single intravitreal injection of THR-687 dose level 2
|
Experimental: THR-687 dose level 3 Subjects in this arm will receive a single intravitreal injection of THR-687 dose level 3 |
Drug: THR-687 dose level 3
single intravitreal injection of THR-687 dose level 3
|
Outcome Measures
Primary Outcome Measures
- Incidence of dose-limiting toxicities up to the Day 14 visit [From Day 0 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
-
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 expected to require confounding treatments / procedures at any time 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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Retina Consultants of Arizona | Phoenix | Arizona | United States | 85053 |
2 | Center for Retina and Macular Disease | Winter Haven | Florida | United States | 33880 |
3 | Midwest Eye Institute | Indianapolis | Indiana | United States | 46290 |
4 | Sierra Eye Associates | Reno | Nevada | United States | 89502 |
5 | Palmetto Retinal Center | West Columbia | South Carolina | United States | 29169 |
6 | Retina Research Institute of Texas | Abilene | Texas | United States | 79606-1224 |
7 | Valley Retina Institute, PA | McAllen | Texas | United States | 78503 |
Sponsors and Collaborators
- ThromboGenics
Investigators
- Study Director: Clinical Department, ThromboGenics Inc. A subsidiary of Oxurion NV.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- THR-687-001