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

Diabetic Retinopathy Clinical Trial

Official title:

A Phase 2, Single-masked, Multicentre Study to Evaluate the Safety and Efficacy of 2 Dose Levels of THR-317 for the Treatment of Diabetic Macular Oedema (DME)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03071068
• Other study ID #: THR-317-001
• Secondary ID: 2016-002100-25
• Status: Completed
• Phase: Phase 2
• First received: February 21, 2017
• Last updated: April 16, 2018
• Start date: December 22, 2016
• Est. completion date: April 2018

Study information

• Verified date: April 2018
• Source: ThromboGenics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Male or female aged 18 years or older

• Type 1 or type 2 diabetes

• Centre-involved DME with CST = 340µm on Spectralis 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 at 4 meters (20/40 and 20/320 Snellen equivalent) in the study eye

• Anti-vascular endothelial growth factor (anti-VEGF) treatment naïve study eye or poor response to prior anti-VEGF treatment in the study eye

• Non-proliferative diabetic retinopathy, or stable proliferative diabetic retinopathy without neovacularisation at the disc

• Written informed consent obtained from the subject prior to screening procedures

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 in the study eyes as follows, or their planned use during the THR-317 treatment period for up to 30 days after the last injection: panretinal or focal / grid laser photocoagulation [3 months], 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 corticosteroids [4 months], 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 suggesting lens / zonular instability

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Edema
• Macular Edema

Intervention

Drug:
• Anti-PlGF recombinant monoclonal antibody, 4mg dose
3 intravitreal injections of THR-317 4mg approximately 1 month apart
• Anti-PlGF recombinant monoclonal antibody, 8mg dose
3 intravitreal injections of THR-317 8mg approximately 1 month apart

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
ThromboGenics

Countries where clinical trial is conducted

Czechia,  Hungary,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Proportion of subjects withdrawn from repeat injection and reason for withdrawal		At day 30 and at day 60
Secondary	Proportion of subjects with a loss of = 15, = 10 or = 5 ETDRS letters in BCVA from baseline by study visit		Up to day 150
Secondary	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
Secondary	Proportion of subjects with a = 15 ETDRS letters gain in BCVA from baseline or = 83 ETDRS letters, by study visit		Up to day 150
Secondary	Mean change from baseline in BCVA, by study visit		Up to day 150
Secondary	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