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

ThromboGenics

Status and phase

Completed

Phase 2

Conditions

Macular Edema

Diabetic Retinopathy

Treatments

Drug: Anti-PlGF recombinant monoclonal antibody, 4mg dose

Drug: Anti-PlGF recombinant monoclonal antibody, 8mg dose

Study type

Interventional

Funder types

Industry

Identifiers

NCT03071068

THR-317-001

2016-002100-25 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment

49 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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