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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

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 Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

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




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 ]


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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

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


Contacts
Contact: Global Clinical Development +32 (0)16 751 310 info@thrombogenics.com

Locations
United States, Arizona
Retina Consultants of Arizona Recruiting
Phoenix, Arizona, United States, 85053
United States, Massachusetts
Ophthalmic Consultants of Boston Recruiting
Boston, Massachusetts, United States, 02114
United States, Nevada
Sierra Eye Associates Recruiting
Reno, Nevada, United States, 89502
United States, Pennsylvania
Mid Atlantic Retina Recruiting
Huntingdon Valley, Pennsylvania, United States, 19006
United States, Texas
Retina Research Institute of Texas Recruiting
Abilene, Texas, United States, 79606
Retinal Research Center, PLLC Recruiting
Austin, Texas, United States, 78705
Retina Consultants of Houston Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
ThromboGenics
Investigators
Study Director: Clinical Department ThromboGenics

Responsible Party: ThromboGenics
ClinicalTrials.gov Identifier: NCT03511898     History of Changes
Other Study ID Numbers: THR-149-001
First Posted: April 30, 2018    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Edema
Macular Edema
Diabetic Retinopathy
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications