Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2025-12-24 @ 5:33 PM
NCT ID:
NCT03071068
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03071068
Study Brief:
Protocol Section:
NCT03071068