Back to resultsA Study to Evaluate the Safety and Efficacy of THR-317 for the Treatment of Diabetic Macular Oedema (DME)
Primary Purpose
Diabetic Retinopathy, Macular Edema
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Anti-PlGF recombinant monoclonal antibody, 4mg dose
Anti-PlGF recombinant monoclonal antibody, 8mg dose
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Retinopathy
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
THR-317 4mg
THR-317 8mg
Arm Description
anti-PlGF recombinant monoclonal antibody, 4mg dose
anti-PlGF recombinant monoclonal antibody, 8mg dose
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Incidence of systemic and ocular (S)AEs up to the 30-day follow-up visit, after each injection and across injections per subject
Incidence of systemic and ocular (S)AEs from first injection up to Day 90 and up to Day 150
Proportion of subjects withdrawn from repeat injection and reason for withdrawal
Proportion of subjects with a loss of ≥ 15, ≥ 10 or ≥ 5 ETDRS letters in BCVA from baseline by study visit
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
Proportion of subjects with a ≥ 15 ETDRS letters gain in BCVA from baseline or ≥ 83 ETDRS letters, by study visit
Mean change from baseline in BCVA, by study visit
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03071068
Brief Title
A Study to Evaluate the Safety and Efficacy of THR-317 for the Treatment of Diabetic Macular Oedema (DME)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
December 22, 2016 (Actual)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
April 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ThromboGenics
4. Oversight
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy, Macular Edema
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
THR-317 4mg
Arm Type
Experimental
Arm Description
anti-PlGF recombinant monoclonal antibody, 4mg dose
Arm Title
THR-317 8mg
Arm Type
Experimental
Arm Description
anti-PlGF recombinant monoclonal antibody, 8mg dose
Intervention Type
Drug
Intervention Name(s)
Anti-PlGF recombinant monoclonal antibody, 4mg dose
Intervention Description
3 intravitreal injections of THR-317 4mg approximately 1 month apart
Intervention Type
Drug
Intervention Name(s)
Anti-PlGF recombinant monoclonal antibody, 8mg dose
Intervention Description
3 intravitreal injections of THR-317 8mg approximately 1 month apart
Primary Outcome Measure Information:
Title
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
Time Frame
up to the 7-day follow-up visit after each injection
Secondary Outcome Measure Information:
Title
Incidence of systemic and ocular (S)AEs up to the 30-day follow-up visit, after each injection and across injections per subject
Time Frame
up to the 30-day follow-up visit after each injection
Title
Incidence of systemic and ocular (S)AEs from first injection up to Day 90 and up to Day 150
Time Frame
From day 0 to day 150
Title
Proportion of subjects withdrawn from repeat injection and reason for withdrawal
Time Frame
At day 30 and at day 60
Title
Proportion of subjects with a loss of ≥ 15, ≥ 10 or ≥ 5 ETDRS letters in BCVA from baseline by study visit
Time Frame
Up to day 150
Title
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
Time Frame
Up to 7-day follow-up visit after each injection
Title
Proportion of subjects with a ≥ 15 ETDRS letters gain in BCVA from baseline or ≥ 83 ETDRS letters, by study visit
Time Frame
Up to day 150
Title
Mean change from baseline in BCVA, by study visit
Time Frame
Up to day 150
Title
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)
Time Frame
Up to day 150
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Department
Organizational Affiliation
ThromboGenics
Official's Role
Study Director
Facility Information:
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
City
Praha 10
ZIP/Postal Code
100 34
Country
Czechia
City
Praha 8
ZIP/Postal Code
180 00
Country
Czechia
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
City
Budapest
ZIP/Postal Code
1133
Country
Hungary
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
City
Pecs
ZIP/Postal Code
7621
Country
Hungary
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
City
Bratislava
ZIP/Postal Code
826 06
Country
Slovakia
City
Bratislava
ZIP/Postal Code
851 07
Country
Slovakia
City
Trenčín
ZIP/Postal Code
911 71
Country
Slovakia
City
Zilina
ZIP/Postal Code
012 07
Country
Slovakia
12. IPD Sharing Statement
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A Study to Evaluate the Safety and Efficacy of THR-317 for the Treatment of Diabetic Macular Oedema (DME)
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