A study to evaluate THR-317 and Lucentis® combination treatment for diabetic macular oedema

Phase 1

• Conditions: Diabetic macular oedema (DME); MedDRA version: 20.1 Level: LLT Classification code 10057915 Term: Diabetic macular oedema System Organ Class: 100000004853; MedDRA version: 20.1 Level: LLT Classification code 10057934 Term: Diabetic macular edema System Organ Class: 100000004853; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2017-003897-15-GB
• Lead Sponsor: Oxurion NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-12-29
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 72

Inclusion Criteria

- Male or female aged 18 years or older
- Type 1 or type 2 diabetes
- CI-DME with central subfield thickness of = 320µm on Spectralis® SD-OCT or = 305µm on non-Spectralis SD-OCT, in the study eye
- 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 (NPDR) of any stage in the study eye
- 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 36
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 36

Exclusion Criteria

- Macular oedema due to causes other than DME
- 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
- Change of the retinal architecture in the centre of the macula of the
study eye that is likely to preclude improvement in BCVA following the
resolution of DME
- Previous treatments / procedures as listed below, or their planned /
expected use during the study period for up to 30 days after the last
study treatment:
* Ranibizumab treatment in the study eye (any time for anti-VEGF naïve
subjects; 1 month for subjects with a poor or no response to
ranibizumab treatment)
* Bevacizumab treatment in the study eye (any time for anti-VEGF naïve
subjects; 3 months for subjects with a poor or no response to
ranibizumab treatment)
* Aflibercept treatment in the study eye (any time)
* Intraocular surgery in the study eye (3 months)
* Focal / grid laser photocoagulation in the study eye (3 months)
* Panretinal laser photocoagulation in the study eye (6 months)
* Intraocular or peri-ocular corticosteroids in the study eye (4 months)
* Ozurdex® (dexamethasone intravitreal implant) in the study eye (6
months)
* Other steroid implant in the study eye (any time)
* Systemic anti-VEGF treatment (3 months)
* Systemic corticosteroids (3 months)
- Aphakic study eye
- Uncontrolled glaucoma in the study eye
- More than 8D high myopia in the study eye
- Any active or suspected periocular / ocular / intraocular infection or
inflammation in either eye
- Untreated diabetes
- Glycated haemoglobin A (HbA1c) > 12%
- Uncontrolled hypertension in the opinion of the Investigator
- Pregnant or lactating female
- Female of child-bearing potential not utilising an adequate form of
contraception, or planning to become pregnant or to discontinue
contraceptive precautions at any time during the entire study period
- Male of reproductive potential not utilising contraception

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified