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

Primary Purpose

Diabetes Mellitus, Diabetic Retinopathy, Diabetic Macular Edema

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

THR-149 dose level 1

THR-149 dose level 2

THR-149 dose level 3

About this trial

This is an interventional treatment trial for Diabetes Mellitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Retina Consultants of Arizona
Ophthalmic Consultants of Boston
Sierra Eye Associates
Mid Atlantic Retina
Retina Research Institute of Texas
Retinal Research Center, PLLC
Retina Consultants of Houston

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

THR-149 dose level 1

THR-149 dose level 2

THR-149 dose level 3

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Incidence of systemic and ocular adverse events including serious adverse events up to the end of the study

Occurrence of laboratory abnormalities up to the end of the study

Full Information

NCT ID

NCT03511898

First Posted

April 10, 2018

Last Updated

June 12, 2019

Sponsor

ThromboGenics

1. Study Identification

Unique Protocol Identification Number

NCT03511898

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Completed

Study Start Date

May 18, 2018 (Actual)

Primary Completion Date

May 22, 2019 (Actual)

Study Completion Date

May 22, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ThromboGenics

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Diabetic Retinopathy, Diabetic Macular Edema

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

THR-149 dose level 1

Arm Type

Experimental

Arm Title

THR-149 dose level 2

Arm Type

Experimental

Arm Title

THR-149 dose level 3

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

THR-149 dose level 1

Intervention Description

single intravitreal injection of THR-149 dose level 1

Intervention Type

Drug

Intervention Name(s)

THR-149 dose level 2

Intervention Description

single intravitreal injection of THR-149 dose level 2

Intervention Type

Drug

Intervention Name(s)

THR-149 dose level 3

Intervention Description

single intravitreal injection of THR-149 dose level 3

Primary Outcome Measure Information:

Title

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

Time Frame

up to Day 14

Secondary Outcome Measure Information:

Title

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

Title

Occurrence of laboratory abnormalities up to the end of the study

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Department

Organizational Affiliation

ThromboGenics

Official's Role

Study Director

Facility Information:

Facility Name

Retina Consultants of Arizona

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85053

Country

United States

Facility Name

Ophthalmic Consultants of Boston

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

Sierra Eye Associates

City

Reno

State/Province

Nevada

ZIP/Postal Code

89502

Country

United States

Facility Name

Mid Atlantic Retina

City

Huntingdon Valley

State/Province

Pennsylvania

ZIP/Postal Code

19006

Country

United States

Facility Name

Retina Research Institute of Texas

City

Abilene

State/Province

Texas

ZIP/Postal Code

79606

Country

United States

Facility Name

Retinal Research Center, PLLC

City

Austin

State/Province

Texas

ZIP/Postal Code

78705

Country

United States

Facility Name

Retina Consultants of Houston

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

12. IPD Sharing Statement

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

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