A Study to Evaluate the Safety of THR-687 in Subjects With Diabetic Macular Edema (DME)

Sponsor
ThromboGenics (Industry)
Overall Status
Completed
CT.gov ID
NCT03666923
Collaborator
(none)
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Study Details

Study Description

Brief Summary

This study is conducted to evaluate the safety of a single intravitreal injection of THR-687.

Condition or Disease Intervention/Treatment Phase
  • Drug: THR-687 dose level 1
  • Drug: THR-687 dose level 2
  • Drug: THR-687 dose level 3
Phase 1

Study Design

Study Type:
Interventional
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-687 for the Treatment of Diabetic Macular Edema (DME)
Actual Study Start Date :
Sep 17, 2018
Actual Primary Completion Date :
Nov 20, 2019
Actual Study Completion Date :
Nov 20, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: THR-687 dose level 1

Subjects in this arm will receive a single intravitreal injection of THR-687 dose level 1

Drug: THR-687 dose level 1
single intravitreal injection of THR-687 dose level 1

Experimental: THR-687 dose level 2

Subjects in this arm will receive a single intravitreal injection of THR-687 dose level 2

Drug: THR-687 dose level 2
single intravitreal injection of THR-687 dose level 2

Experimental: THR-687 dose level 3

Subjects in this arm will receive a single intravitreal injection of THR-687 dose level 3

Drug: THR-687 dose level 3
single intravitreal injection of THR-687 dose level 3

Outcome Measures

Primary Outcome Measures

  1. Incidence of dose-limiting toxicities up to the Day 14 visit [From Day 0 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 [From Day 0 up to Day 84]

  2. Occurrence of laboratory abnormalities up to the end of the study [At Screening, Day 1, Day 7, Day 28 and Day 84]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 expected to require confounding treatments / procedures at any time 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

Locations

Site City State Country Postal Code
1 Retina Consultants of Arizona Phoenix Arizona United States 85053
2 Center for Retina and Macular Disease Winter Haven Florida United States 33880
3 Midwest Eye Institute Indianapolis Indiana United States 46290
4 Sierra Eye Associates Reno Nevada United States 89502
5 Palmetto Retinal Center West Columbia South Carolina United States 29169
6 Retina Research Institute of Texas Abilene Texas United States 79606-1224
7 Valley Retina Institute, PA McAllen Texas United States 78503

Sponsors and Collaborators

  • ThromboGenics

Investigators

  • Study Director: Clinical Department, ThromboGenics Inc. A subsidiary of Oxurion NV.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
ThromboGenics
ClinicalTrials.gov Identifier:
NCT03666923
Other Study ID Numbers:
  • THR-687-001
First Posted:
Sep 12, 2018
Last Update Posted:
Jan 22, 2020
Last Verified:
Jan 1, 2020
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 22, 2020