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

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ClinicalTrials.gov Identifier: NCT03511898
Recruitment Status : Recruiting
First Posted : April 30, 2018
Last Update Posted : August 7, 2018
Sponsor:
Information provided by (Responsible Party):
ThromboGenics

April 10, 2018
April 30, 2018
August 7, 2018
May 18, 2018
March 2019   (Final data collection date for primary outcome measure)
Incidence of dose-limiting toxicities up to the Day 14 visit [ Time Frame: up to Day 14 ]
Same as current
Complete list of historical versions of study NCT03511898 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Occurrence of laboratory abnormalities up to the end of the study [ Time Frame: At Screening, Day 1, Day 7, Day 28 and Day 84 ]
Same as current
Not Provided
Not Provided
 
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)
This study is conducted to evaluate the safety of a single intravitreal injection of THR-149.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Diabetes Mellitus
  • Diabetic Retinopathy
  • Diabetic Macular Edema
  • Drug: THR-149 dose level 1
    single intravitreal injection of THR-149 dose level 1
  • Drug: THR-149 dose level 2
    single intravitreal injection of THR-149 dose level 2
  • Drug: THR-149 dose level 3
    single intravitreal injection of THR-149 dose level 3
  • Experimental: THR-149 dose level 1
    Intervention: Drug: THR-149 dose level 1
  • Experimental: THR-149 dose level 2
    Intervention: Drug: THR-149 dose level 2
  • Experimental: THR-149 dose level 3
    Intervention: Drug: THR-149 dose level 3
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
12
Same as current
March 2019
March 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Global Clinical Development +32 (0)16 751 310 info@thrombogenics.com
United States
 
 
NCT03511898
THR-149-001
Not Provided
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
ThromboGenics
ThromboGenics
Not Provided
Study Director: Clinical Department ThromboGenics
ThromboGenics
August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP