Back to resultsA Study to Evaluate the Safety of THR-687 in Subjects With Diabetic Macular Edema (DME)
Primary Purpose
Diabetes Mellitus, Diabetic Retinopathy, Diabetic Macular Edema
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
THR-687 dose level 1
THR-687 dose level 2
THR-687 dose level 3
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus
Eligibility 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
Sites / Locations
- Retina Consultants of Arizona
- Center for Retina and Macular Disease
- Midwest Eye Institute
- Sierra Eye Associates
- Palmetto Retinal Center
- Retina Research Institute of Texas
- Valley Retina Institute, PA
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
THR-687 dose level 1
THR-687 dose level 2
THR-687 dose level 3
Arm Description
Subjects in this arm will receive a single intravitreal injection of THR-687 dose level 1
Subjects in this arm will receive a single intravitreal injection of THR-687 dose level 2
Subjects in this arm will receive a single intravitreal injection of THR-687 dose level 3
Outcomes
Primary Outcome Measures
Incidence of dose-limiting toxicities up to the Day 14 visit
Secondary Outcome Measures
Incidence of systemic and ocular adverse events including serious adverse events up to the end of the study
Occurrence of laboratory abnormalities up to the end of the study
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03666923
Brief Title
A Study to Evaluate the Safety of THR-687 in Subjects With Diabetic Macular Edema (DME)
Official Title
A Phase 1, Open-label, Multicenter, Dose Escalation Study to Evaluate the Safety of a Single Intravitreal Injection of THR-687 for the Treatment of Diabetic Macular Edema (DME)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
September 17, 2018 (Actual)
Primary Completion Date
November 20, 2019 (Actual)
Study Completion Date
November 20, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ThromboGenics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study is conducted to evaluate the safety of a single intravitreal injection of THR-687.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Diabetic Retinopathy, Diabetic Macular Edema
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
THR-687 dose level 1
Arm Type
Experimental
Arm Description
Subjects in this arm will receive a single intravitreal injection of THR-687 dose level 1
Arm Title
THR-687 dose level 2
Arm Type
Experimental
Arm Description
Subjects in this arm will receive a single intravitreal injection of THR-687 dose level 2
Arm Title
THR-687 dose level 3
Arm Type
Experimental
Arm Description
Subjects in this arm will receive a single intravitreal injection of THR-687 dose level 3
Intervention Type
Drug
Intervention Name(s)
THR-687 dose level 1
Intervention Description
single intravitreal injection of THR-687 dose level 1
Intervention Type
Drug
Intervention Name(s)
THR-687 dose level 2
Intervention Description
single intravitreal injection of THR-687 dose level 2
Intervention Type
Drug
Intervention Name(s)
THR-687 dose level 3
Intervention Description
single intravitreal injection of THR-687 dose level 3
Primary Outcome Measure Information:
Title
Incidence of dose-limiting toxicities up to the Day 14 visit
Time Frame
From Day 0 up to Day 14
Secondary Outcome Measure Information:
Title
Incidence of systemic and ocular adverse events including serious adverse events up to the end of the study
Time Frame
From Day 0 up to Day 84
Title
Occurrence of laboratory abnormalities up to the end of the study
Time Frame
At Screening, Day 1, Day 7, Day 28 and Day 84
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Department
Organizational Affiliation
ThromboGenics Inc. A subsidiary of Oxurion NV.
Official's Role
Study Director
Facility Information:
Facility Name
Retina Consultants of Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85053
Country
United States
Facility Name
Center for Retina and Macular Disease
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33880
Country
United States
Facility Name
Midwest Eye Institute
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
Sierra Eye Associates
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
Palmetto Retinal Center
City
West Columbia
State/Province
South Carolina
ZIP/Postal Code
29169
Country
United States
Facility Name
Retina Research Institute of Texas
City
Abilene
State/Province
Texas
ZIP/Postal Code
79606-1224
Country
United States
Facility Name
Valley Retina Institute, PA
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Safety of THR-687 in Subjects With Diabetic Macular Edema (DME)
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