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A Study to Evaluate THR-687 Treatment for Diabetic Macular Oedema. | Clinical Trials | Clareo Health

TERMINATEDPHASE2

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

A Phase 2, Randomised, Multicentre Study to Assess the Dose Level of Multiple THR-687 Injections and to Evaluate the Efficacy and Safety of THR-687 Versus Aflibercept for the Treatment of Diabetic Macular Oedema (DME)

NCT05063734•Oxurion

View on ClinicalTrials.gov

Summary

This study is conducted to select the THR-687 dose level (Part A of the study) and to assess the efficacy and safety of the selected dose level compared to aflibercept (Part B of the study).

Detailed Description

In Part A, approximately 12 subjects are planned to be randomized (1:1 allocation) to THR-687 1.2mg and THR-687 2.0mg. In Part B, in the cohort of Treatment Naïve subjects are planned to be randomized (2:1 allocation) to THR-687 selected dose level from Part A and Aflibercept 2.0mg. In Part B, in the cohort of Previously Treated subjects are planned to be randomized (1:1 allocation) to THR-687 selected dose level from Part A and Aflibercept 2.0mg. All subjects in the study will receive study treatment in one selected study eye only.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•The subjects in this study will be subjects with central-involved DME (CI-DME). Both treatment-naïve and previously treated subjects will be included.
•Written informed consent obtained from the subject prior to screening procedures
•Male or female aged 18 years or older at the time of signing the informed consent
•Type 1 or type 2 diabetes
•BCVA ETDRS letter score ≥ 39 in the study eye
•CI-DME with CST of ≥ 300µm in men (or equivalent in women), measured from RPE to ILM inclusively, on SD-OCT, in the study eye
•BCVA ETDRS letter score ≥ 34 in the fellow eye

Exclusion Criteria

•Macular edema due to causes other than DME in the study eye
•Concurrent disease in the study eye, other than DME, that could require medical or surgical intervention during the study period or could confound interpretation of the results
•Any condition in the study eye that could confound the ability to detect the efficacy of the investigational medicinal product
•Previous confounding medications / interventions, or their planned administration during the study
•Presence of iris neovascularisation in the study eye
•Uncontrolled glaucoma in the study eye
•Previously received THR-687 or any other experimental therapy for DME, in either eye
•Any active or suspected ocular or periocular infection, or active intraocular inflammation, in either eye
•Untreated Diabetes
•Glycated haemoglobin A (HbA1c) \> 12%
+1 more criteria

Locations (25)

Salehi Retina Institute Inc.

Huntington Beach, California, United States

California Eye Specialists Medical Group, Inc.

Pasadena, California, United States

Retinal Consultants Medical Group

Sacramento, California, United States

Retina Consultants of Southern Colorado, P.C.

Colorado Springs, Colorado, United States

Retina Associates, Ltd

Elmhurst, Illinois, United States

University Retina and macula Associates, PC

Oak Forest, Illinois, United States

Cumberland Valley Retina Consultants

Hagerstown, Maryland, United States

Sierra Eye Associates

Reno, Nevada, United States

Retina Vitreous Surgeons of Central New York, PC

Liverpool, New York, United States

Tulsa Retina Consultants

Tulsa, Oklahoma, United States

Key Dates

Start Date

August 27, 2021

Primary Completion Date

June 29, 2022

Completion Date

June 29, 2022

Last Updated

August 18, 2023

Enrollment

ACTUAL participants

Conditions

Diabetes MellitusDiabetic RetinopathyDiabetic Macular Edema

Interventions

THR-687 dose level 1

DRUG

THR-687 dose level 2

DRUG

THR-687 selected dose level

DRUG

Aflibercept

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: August 18, 2023Data 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.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

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