A Study to Evaluate the Safety and Efficacy of THR-317 for the Treatment of Diabetic Macular Oedema (DME)

Phase 2

Completed

• Conditions: Macular Edema; Diabetic Retinopathy
• Interventions: Drug: Anti-PlGF recombinant monoclonal antibody, 4mg dose; Drug: Anti-PlGF recombinant monoclonal antibody, 8mg dose

• Registration Number: NCT03071068
• Lead Sponsor: ThromboGenics

Brief Summary

This study is conducted to evaluate the safety of THR-317 when administered intravitreally and to assess the compound's efficacy in improving best-corrected visual acuity (BCVA) and reducing central subfield thickness (CST) in subjects with centre-involved diabetic macular oedema (DME).

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-22
• Study First Submitted: 2017-02-21
• Study First Submitted QC: 2017-02-28
• Study First Posted: 2017-03-06
• Status Verified: 2018-04
• Primary Completion: 2018-04
• Study Completion: 2018-04
• Last Update Submitted: 2018-04-16
• Last Update Posted: 2018-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
THR-317 4mg	Anti-PlGF recombinant monoclonal antibody, 4mg dose	anti-PlGF recombinant monoclonal antibody, 4mg dose
THR-317 8mg	Anti-PlGF recombinant monoclonal antibody, 8mg dose	anti-PlGF recombinant monoclonal antibody, 8mg dose

Primary Outcome Measures

Name	Time	Method
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	up to the 7-day follow-up visit after each injection

Secondary Outcome Measures

Name	Time	Method
Incidence of systemic and ocular (S)AEs up to the 30-day follow-up visit, after each injection and across injections per subject	up to the 30-day follow-up visit after each injection
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	Up to 7-day follow-up visit after each injection
Proportion of subjects with a loss of ≥ 15, ≥ 10 or ≥ 5 ETDRS letters in BCVA from baseline by study visit	Up to day 150
Mean change from baseline in BCVA, by study visit	Up to day 150
Mean change from baseline in CST, by study visit, based on spectral domain optical coherence tomography (SD-OCT), as assessed by the central reading centre (CRC)	Up to day 150
Proportion of subjects withdrawn from repeat injection and reason for withdrawal	At day 30 and at day 60
Proportion of subjects with a ≥ 15 ETDRS letters gain in BCVA from baseline or ≥ 83 ETDRS letters, by study visit	Up to day 150
Incidence of systemic and ocular (S)AEs from first injection up to Day 90 and up to Day 150	From day 0 to day 150