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

NCT03071068 | Completed Phase 2

• 2 other identifiers: THR-317-0012016-002100-25
• Study Type: interventional
• Target: 49
• Locations: 3 countries
• Sites: 13

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).

Conditions

Diabetic Retinopathy; Macular Edema

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

• 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

• Proportion of subjects withdrawn from repeat injection and reason for withdrawal

  At day 30 and at day 60

• Proportion of subjects with a loss of ≥ 15, ≥ 10 or ≥ 5 ETDRS letters in BCVA from baseline by study visit

  Up to day 150

• 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

Study Arms (2)

THR-317 4mg

EXPERIMENTAL

anti-PlGF recombinant monoclonal antibody, 4mg dose

Drug: Anti-PlGF recombinant monoclonal antibody, 4mg dose

THR-317 8mg

EXPERIMENTAL

anti-PlGF recombinant monoclonal antibody, 8mg dose

Drug: Anti-PlGF recombinant monoclonal antibody, 8mg dose

Interventions

Anti-PlGF recombinant monoclonal antibody, 4mg dose DRUG

3 intravitreal injections of THR-317 4mg approximately 1 month apart

THR-317 4mg

Anti-PlGF recombinant monoclonal antibody, 8mg dose DRUG

3 intravitreal injections of THR-317 8mg approximately 1 month apart

THR-317 8mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ThromboGenics: lead

Study Sites (13)

Unknown Facility

Brno, 625 00, Czechia

Location

Unknown Facility

Hradec Králové, 500 05, Czechia

Location

Unknown Facility

Prague, 100 34, Czechia

Location

Unknown Facility

Prague, 180 00, Czechia

Location

Unknown Facility

Budapest, 1083, Hungary

Location

Unknown Facility

Budapest, 1133, Hungary

Location

Unknown Facility

Debrecen, 4032, Hungary

Location

Unknown Facility

Pécs, 7621, Hungary

Location

Unknown Facility

Szeged, 6720, Hungary

Location

Unknown Facility

Bratislava, 826 06, Slovakia

Location

Unknown Facility

Bratislava, 851 07, Slovakia

Location

Unknown Facility

Trenčín, 911 71, Slovakia

Location

Unknown Facility

Žilina, 012 07, Slovakia

Location

MeSH Terms

Conditions

Diabetic Retinopathy; Macular Edema

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Macular Degeneration; Retinal Degeneration

Study Officials

• Clinical Department

  ThromboGenics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2017
• First Posted: March 6, 2017
• Study Start: December 22, 2016
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: April 17, 2018

Record last verified: 2018-04

Locations

HU (5); SL (4); CZ (4)