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Trial record 1 of 2 for:    THR-149
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A Study to Evaluate the Safety of THR-149 in Subjects With Diabetic Macular Edema (DME)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03511898
Recruitment Status : Completed
First Posted : April 30, 2018
Last Update Posted : June 13, 2019
Sponsor:
Information provided by (Responsible Party):
Oxurion ( ThromboGenics )

Study Description
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Brief Summary:
This study is conducted to evaluate the safety of a single intravitreal injection of THR-149.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Diabetic Retinopathy Diabetic Macular Edema Drug: THR-149 dose level 1 Drug: THR-149 dose level 2 Drug: THR-149 dose level 3 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : May 18, 2018
Actual Primary Completion Date : May 22, 2019
Actual Study Completion Date : May 22, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Incidence of dose-limiting toxicities up to the Day 14 visit [ Time Frame: up to Day 14 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Occurrence of laboratory abnormalities up to the end of the study [ Time Frame: At Screening, Day 1, Day 7, Day 28 and Day 84 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03511898


Locations
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United States, Arizona
Retina Consultants of Arizona
Phoenix, Arizona, United States, 85053
United States, Massachusetts
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States, 02114
United States, Nevada
Sierra Eye Associates
Reno, Nevada, United States, 89502
United States, Pennsylvania
Mid Atlantic Retina
Huntingdon Valley, Pennsylvania, United States, 19006
United States, Texas
Retina Research Institute of Texas
Abilene, Texas, United States, 79606
Retinal Research Center, PLLC
Austin, Texas, United States, 78705
Retina Consultants of Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
ThromboGenics
Investigators
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Study Director: Clinical Department ThromboGenics
More Information
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Responsible Party: ThromboGenics
ClinicalTrials.gov Identifier: NCT03511898    
Other Study ID Numbers: THR-149-001
First Posted: April 30, 2018    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Macular Edema
Diabetic Retinopathy
Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
 Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases