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: 20.1Level: LLTClassification code 10057915Term: Diabetic macular oedemaSystem Organ Class: 100000004853; MedDRA version: 20.1Level: LLTClassification code 10057934Term: Diabetic macular edemaSystem Organ Class: 100000004853; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2016-002100-25-CZ
• Lead Sponsor: ThromboGenics NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-08
• Last Update Posted: 28 May 2018

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 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