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

PHASE2

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-22

Study Completion Date

2018-04-30

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 THR-317 when administered intravitreally and to assess the compound's efficacy in improving best-corrected visual acuity (BCVA) and reducing central subfield thickness (CST) in subjects with centre-involved diabetic macular oedema (DME).

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 of THR-149 in Subjects With Diabetic Macular Edema (DME)

NCT03511898

Diabetes Mellitus Diabetic Retinopathy Diabetic Macular Edema

COMPLETED PHASE1

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

NCT05063734

Diabetes Mellitus Diabetic Retinopathy Diabetic Macular Edema

TERMINATED PHASE2

A Phase 2a Study to Evaluate the Safety, Tolerability, and Efficacy of SNP318 in DME Patients

NCT07199777

Diabetic Macular Edema DME

NOT_YET_RECRUITING 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.

Diabetic Retinopathy Macular Edema

Study Design

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

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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

THR-317 4mg

anti-PlGF recombinant monoclonal antibody, 4mg dose

Group Type EXPERIMENTAL

Anti-PlGF recombinant monoclonal antibody, 4mg dose

Intervention Type DRUG

3 intravitreal injections of THR-317 4mg approximately 1 month apart

THR-317 8mg

anti-PlGF recombinant monoclonal antibody, 8mg dose

Group Type EXPERIMENTAL

Anti-PlGF recombinant monoclonal antibody, 8mg dose

Intervention Type DRUG

3 intravitreal injections of THR-317 8mg approximately 1 month apart

Interventions

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

Anti-PlGF recombinant monoclonal antibody, 4mg dose

3 intravitreal injections of THR-317 4mg approximately 1 month apart

Intervention Type DRUG

Anti-PlGF recombinant monoclonal antibody, 8mg dose

3 intravitreal injections of THR-317 8mg approximately 1 month apart

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
* Centre-involved DME with CST ≥ 340µm on Spectralis SD-OCT or ≥ 320µm on non-Spectralis SD OCT, in the study eye
* Reduced vision primarily due to DME, with BCVA between 72 and 23 ETDRS letters read at 4 meters (20/40 and 20/320 Snellen equivalent) in the study eye
* Anti-vascular endothelial growth factor (anti-VEGF) treatment naïve study eye or poor response to prior anti-VEGF treatment in the study eye
* Non-proliferative diabetic retinopathy, or stable proliferative diabetic retinopathy without neovacularisation at the disc
* Written informed consent obtained from the subject prior to screening procedures

Exclusion Criteria

* Concurrent disease in the study eye, other than DME, that could compromise BCVA, require medical or surgical intervention during the study period or could confound interpretation of the results
* Previous treatments / procedures in the study eyes as follows, or their planned use during the THR-317 treatment period for up to 30 days after the last injection: panretinal or focal / grid laser photocoagulation \[3 months\], anti-VEGF treatment \[any time for anti-VEGF naïve subjects; 4 weeks for subjects with a poor response to anti-VEGF treatment\], intra-ocular or peri-ocular corticosteroids \[4 months\], steroid implant \[any time\], intra-ocular surgery \[3 months\], vitrectomy \[any time\]
* Any active ocular / intra-ocular infection or inflammation in either eye
* Aphakic study eye
* Untreated diabetes
* Glycated haemoglobin A (HbA1c) \> 12%
* Uncontrolled hypertension in the opinion of the Investigator
* Pregnant or lactating female or female of child-bearing potential not utilising an adequate form of contraception or male of reproductive potential not utilising contraception suggesting lens / zonular instability

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No