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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03499223
• Date of registration: 04/04/2018
• Prospective Registration: Yes
• Primary sponsor: Oxurion
• Public title: A Study to Evaluate THR-317 and Ranibizumab Combination Treatment for Diabetic Macular Oedema (DME)
• Scientific title: A Phase 2, Randomised, Single-masked, Active-controlled, Multicentre Study to Evaluate the Efficacy and Safety of Intravitreal THR-317 Administered in Combination With Ranibizumab, for the Treatment of Diabetic Macular Oedema (DME)
• Date of first enrolment: April 20, 2018
• Target sample size: 70
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03499223
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
• Phase: Phase 2

Countries of recruitment

Belgium, France, Germany, Slovakia, Spain, Switzerland, United Kingdom

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Diabetes Mellitus

Diabetic Retinopathy

Macular Edema

Intervention(s)

Drug: THR-317 8mg

Drug: Ranibizumab 0.5mg

Drug: Sham injection

Primary Outcome(s)

Change from baseline in BCVA [Time Frame: At Day 84 (Month 3)]

Secondary Outcome(s)

Withdrawal from repeat study treatment and reason for withdrawal [Time Frame: At Day 28 and at Day 56]

Change from baseline in CST, based on spectral domain optical coherence tomography (SD-OCT), as assessed by the central reading centre, by study visit [Time Frame: From Screening to Day 140]

Change from baseline in BCVA, by study visit [Time Frame: From Day 0 to Day 140]

Incidence of systemic and ocular adverse events including serious adverse events [Time Frame: From Day 0 to Day 140]

Secondary ID(s)

2017-003897-15

THR-317-002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors