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COMPLETEDPHASE1

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

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)

NCT03511898•ThromboGenics

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - No limit years

Sex

ALL

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

Locations (7)

Retina Consultants of Arizona

Phoenix, Arizona, United States

Ophthalmic Consultants of Boston

Boston, Massachusetts, United States

Sierra Eye Associates

Reno, Nevada, United States

Mid Atlantic Retina

Huntingdon Valley, Pennsylvania, United States

Retina Research Institute of Texas

Abilene, Texas, United States

Retinal Research Center, PLLC

Austin, Texas, United States

Retina Consultants of Houston

Houston, Texas, United States

Key Dates

Start Date

May 18, 2018

Primary Completion Date

May 22, 2019

Completion Date

May 22, 2019

Last Updated

June 13, 2019

Enrollment

ACTUAL participants

Conditions

Diabetes MellitusDiabetic RetinopathyDiabetic Macular Edema

Interventions

THR-149 dose level 1

DRUG

THR-149 dose level 2

DRUG

THR-149 dose level 3

DRUG

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

View study

RECRUITING

Genetic Studies of Insulin and Diabetes

NCT00001987

Diabetes MellitusSevere Insulin Resistance

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 13, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

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