A study to evaluate whether 2 concentrations of THR-317 safely work to treat diabetic macular oedema

Phase 1

Conditions: diabetic macular oedema (DME)
MedDRA version: 20.0Level: LLTClassification code 10057915Term: Diabetic macular oedemaSystem Organ Class: 100000015084
MedDRA version: 20.0Level: LLTClassification code 10057934Term: Diabetic macular edemaSystem Organ Class: 100000015084
Therapeutic area: Diseases [C] - Eye Diseases [C11]

Registration Number: EUCTR2016-002100-25-HU

Lead Sponsor: ThromboGenics NV

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 50

Inclusion Criteria

• Male or female aged 18 years or older
• Type 1 or type 2 diabetes
• Centre-involved DME with central subfield thickness (CST) = 340µm on Spectralis spectral domain optical coherence tomography (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 (20/40 and 20/320 Snellen equivalent) in the study eye
• Anti-VEGF treatment naïve study eye or poor response to prior anti-VEGF treatment in the study eye
• Non-proliferative diabetic retinopathy (NPDR) or stable proliferative diabetic retinopathy (PDR) without neovacularisation at the disc (NVD)
• Written informed consent obtained from the subject prior to screening procedures

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

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 as listed below or their planned use during the THR-317 treatment period for up to 30 days after the last injection
Treatment / Procedure in Excluded Period prior to
the Study Eye Visit 2 (Day 0)
Panretinal or focal / grid laser 3 months
photocoagulation
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 4 months
corticosteroids
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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the safety of 3 intravitreal injections of 2 dose levels of THR-317 (4mg or 8mg) and to assess its efficacy in improving best-corrected visual acuity (BCVA) and reducing central subfield thickness (CST), in subjects with centre-involved DME;Secondary Objective: Not applicable;Primary end point(s): • Incidence of acute (up to the 7 day follow-up visit) ocular (serious) adverse events ([S]AEs) in the study eye, after each injection and across injections per subject;Timepoint(s) of evaluation of this end point: up to 7-day follow-up visit after each injection

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): • Incidence of systemic and ocular (S)AEs up to the 30 day follow-up visit, after each injection and across injections per subject<br>• Incidence of systemic and ocular (S)AEs from first injection up to Day 90 and up to Day 150<br>• Proportion of subjects withdrawn from repeat injection and reason for withdrawal<br>• Proportion of subjects with a loss of = 15, = 10 or = 5 ETDRS letters in BCVA from baseline by study visit<br>• Proportion of subjects with an acute loss (up to the 7 day follow-up visit) of = 15, = 10 or = 5 ETDRS letters in BCVA after each injection<br>• Proportion of subjects with a = 15 ETDRS letters gain in BCVA from baseline or = 83 ETDRS letters, by study visit<br>• Mean change from baseline in BCVA, by study visit<br>• Mean change from baseline in CST, by study visit, based on SD-OCT;Timepoint(s) of evaluation of this end point: from baseline to end of study

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