A Study to Evaluate the Safety of THR-149 in Subjects With Diabetic Macular Edema (DME)
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)
1 other identifier
interventional
12
1 country
7
Brief Summary
This study is conducted to evaluate the safety of a single intravitreal injection of THR-149.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 diabetes-mellitus
Started May 2018
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 10, 2018
CompletedFirst Posted
Study publicly available on registry
April 30, 2018
CompletedStudy Start
First participant enrolled
May 18, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 22, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 22, 2019
CompletedJune 13, 2019
June 1, 2019
1 year
April 10, 2018
June 12, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of dose-limiting toxicities up to the Day 14 visit
up to Day 14
Secondary Outcomes (2)
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
Study Arms (3)
THR-149 dose level 1
EXPERIMENTALTHR-149 dose level 2
EXPERIMENTALTHR-149 dose level 3
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ThromboGenicslead
Study Sites (7)
Retina Consultants of Arizona
Phoenix, Arizona, 85053, United States
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114, United States
Sierra Eye Associates
Reno, Nevada, 89502, United States
Mid Atlantic Retina
Huntingdon Valley, Pennsylvania, 19006, United States
Retina Research Institute of Texas
Abilene, Texas, 79606, United States
Retinal Research Center, PLLC
Austin, Texas, 78705, United States
Retina Consultants of Houston
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Department
ThromboGenics
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 10, 2018
First Posted
April 30, 2018
Study Start
May 18, 2018
Primary Completion
May 22, 2019
Study Completion
May 22, 2019
Last Updated
June 13, 2019
Record last verified: 2019-06