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

June 12, 2019 updated by: ThromboGenics

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85053
        • Retina Consultants of Arizona
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Ophthalmic Consultants of Boston
    • Nevada
      • Reno, Nevada, United States, 89502
        • Sierra Eye Associates
    • Pennsylvania
      • Huntingdon Valley, Pennsylvania, United States, 19006
        • Mid Atlantic Retina
    • Texas
      • Abilene, Texas, United States, 79606
        • Retina Research Institute of Texas
      • Austin, Texas, United States, 78705
        • Retinal Research Center, PLLC
      • Houston, Texas, United States, 77030
        • Retina Consultants of Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of dose-limiting toxicities up to the Day 14 visit
Time Frame: up to Day 14
up to Day 14

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
At Screening, Day 1, Day 7, Day 28 and Day 84

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ThromboGenics

Investigators

  • Study Director: Clinical Department, ThromboGenics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 18, 2018

Primary Completion (Actual)

May 22, 2019

Study Completion (Actual)

May 22, 2019

Study Registration Dates

First Submitted

April 10, 2018

First Submitted That Met QC Criteria

April 27, 2018

First Posted (Actual)

April 30, 2018

Study Record Updates

Last Update Posted (Actual)

June 13, 2019

Last Update Submitted That Met QC Criteria

June 12, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • THR-149-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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