NCT03666923

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1 diabetes-mellitus

Timeline
Completed

Started Sep 2018

Typical duration for phase_1 diabetes-mellitus

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 12, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

September 17, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2019

Completed
Last Updated

January 22, 2020

Status Verified

January 1, 2020

Enrollment Period

1.2 years

First QC Date

September 7, 2018

Last Update Submit

January 20, 2020

Conditions

Diabetes MellitusDiabetic RetinopathyDiabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

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

    From Day 0 up to Day 14

Secondary Outcomes (2)

  • 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

  • Occurrence of laboratory abnormalities up to the end of the study

    At Screening, Day 1, Day 7, Day 28 and Day 84

Study Arms (3)

THR-687 dose level 1

EXPERIMENTAL

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

Drug: THR-687 dose level 1

THR-687 dose level 2

EXPERIMENTAL

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

Drug: THR-687 dose level 2

THR-687 dose level 3

EXPERIMENTAL

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

Drug: THR-687 dose level 3

Interventions

THR-687 dose level 1DRUG

single intravitreal injection of THR-687 dose level 1

THR-687 dose level 1
THR-687 dose level 2DRUG

single intravitreal injection of THR-687 dose level 2

THR-687 dose level 2
THR-687 dose level 3DRUG

single intravitreal injection of THR-687 dose level 3

THR-687 dose level 3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Retina Consultants of Arizona

Phoenix, Arizona, 85053, United States

Location

Center for Retina and Macular Disease

Winter Haven, Florida, 33880, United States

Location

Midwest Eye Institute

Indianapolis, Indiana, 46290, United States

Location

Sierra Eye Associates

Reno, Nevada, 89502, United States

Location

Palmetto Retinal Center

West Columbia, South Carolina, 29169, United States

Location

Retina Research Institute of Texas

Abilene, Texas, 79606-1224, United States

Location

Valley Retina Institute, PA

McAllen, Texas, 78503, United States

Location

MeSH Terms

Conditions

Diabetes MellitusDiabetic Retinopathy

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesRetinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes Complications

Study Officials

  • Clinical Department

    ThromboGenics Inc. A subsidiary of Oxurion NV.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2018

First Posted

September 12, 2018

Study Start

September 17, 2018

Primary Completion

November 20, 2019

Study Completion

November 20, 2019

Last Updated

January 22, 2020

Record last verified: 2020-01

Locations

US(7)