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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-18

Study Completion Date

2019-05-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT03666923

Diabetes Mellitus Diabetic Retinopathy Diabetic Macular Edema

COMPLETED PHASE1

A Study to Evaluate THR-149 Treatment for Diabetic Macular Oedema

NCT04527107

Diabetes Mellitus Diabetic Retinopathy Diabetic Macular Edema

COMPLETED PHASE2

A Study to Evaluate the Safety and Efficacy of THR-317 for the Treatment of Diabetic Macular Oedema (DME)

NCT03071068

Diabetic Retinopathy Macular Edema

COMPLETED PHASE2

A Study to Evaluate THR-687 Treatment for Diabetic Macular Oedema.

NCT05063734

Diabetes Mellitus Diabetic Retinopathy Diabetic Macular Edema

TERMINATED PHASE2

Topical Ocular Mecamylamine in Diabetic Macular Edema (DME)

NCT00536692

Diabetic Macular Edema

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus Diabetic Retinopathy Diabetic Macular Edema

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

THR-149 dose level 1

Group Type EXPERIMENTAL

THR-149 dose level 1

Intervention Type DRUG

single intravitreal injection of THR-149 dose level 1

THR-149 dose level 2

Group Type EXPERIMENTAL

THR-149 dose level 2

Intervention Type DRUG

single intravitreal injection of THR-149 dose level 2

THR-149 dose level 3

Group Type EXPERIMENTAL

THR-149 dose level 3

Intervention Type DRUG

single intravitreal injection of THR-149 dose level 3

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

THR-149 dose level 1

single intravitreal injection of THR-149 dose level 1

Intervention Type DRUG

THR-149 dose level 2

single intravitreal injection of THR-149 dose level 2

Intervention Type DRUG

THR-149 dose level 3

single intravitreal injection of THR-149 dose level 3

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No