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Completed

NCT Number: NCT03511898

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

This study is conducted to evaluate the safety of a single intravitreal injection of THR-149.

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Key information

Conditions

Diabetes Mellitus Cardiovascular Diseases Diabetes Complications Diabetic Angiopathies Diabetic Macular Edema Diabetic Retinopathy Endocrine System Diseases Eye Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Retinal Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Retina Consultants of Arizona, Phoenix, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

THR-149 dose level 1

Drug

single intravitreal injection of THR-149 dose level 1

THR-149 dose level 2

Drug

single intravitreal injection of THR-149 dose level 2

THR-149 dose level 3

Drug

single intravitreal injection of THR-149 dose level 3

Primary outcomes

  1. Incidence of dose-limiting toxicities up to the Day 14 visit

    Time frame: up to Day 14

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

ThromboGenics

Industry

Registry information

Official study 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)

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 30, 2018
Registry last updated
Jun 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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