A Study to Evaluate THR-317 and Ranibizumab Combination Treatment for Diabetic Macular Oedema (DME)

• Ranibizumab 0.5mg (Drug), also known as Lucentis®: 3 intravitreal injections of ranibizumab 0.5mg, approximately 1 month apart
• THR-317 8mg (Drug): 3 intravitreal injections of THR-317 8mg, approximately 1 month apart
• Sham injection (Drug): 3 sham injections, approximately 1 month apart. No actual injections. No medication is used.

Primary outcomes

• Change from baseline in BCVA [At Day 84 (Month 3)]

Secondary outcomes

• Incidence of systemic and ocular adverse events including serious adverse events [From Day 0 to Day 140]
• Change from baseline in BCVA, by study visit [From Day 0 to Day 140]
• Change from baseline in CST, based on spectral domain optical coherence tomography (SD-OCT), as assessed by the central reading centre, by study visit [From Screening to Day 140]
• Withdrawal from repeat study treatment and reason for withdrawal [At Day 28 and at Day 56]: Number of subjects meeting withdrawal criteria from repeat study treatment

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Male or female aged 18 years or older
* Type 1 or type 2 Diabetes Mellitus
* CI-DME with central subfield thickness of ≥ 320μm on Spectralis® SD-OCT or ≥ 305μm on non Spectralis SD-OCT, in the study eye
* Anti-vascular endothelial growth factor (anti-VEGF) treatment naïve study eye, or poor or no response to prior treatment with ranibizumab in the study eye
* Reduced vision primarily due to DME, with BCVA ≤ 72 and ≥ 23 ETDRS letter score (≤ 20/40 and ≥ 20/320 Snellen equivalent) in the study eye
* Non-proliferative diabetic retinopathy of any stage in the study eye
* Written informed consent obtained from the subject prior to screening procedures

Exclusion Criteria:

* Concurrent disease in the study eye, other than CI-DME, that could compromise BCVA, require medical or surgical intervention during the study period or could confound interpretation of the results
* Previous confounding treatments / procedures, or their planned / expected use during the study period for up to 30 days after the last administration of study treatment
* Any active ocular / intraocular infection or inflammation in either eye
* Aphakic study eye
* Poorly controlled Diabetes Mellitus
* Uncontrolled hypertension
* 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

NIH grants: 2017