Clinical Trial Results:
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)
Summary
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EudraCT number |
2016-002100-25 |
Trial protocol |
HU CZ SK |
Global end of trial date |
11 Apr 2018
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Results information
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Results version number |
v1(current) |
This version publication date |
31 Mar 2019
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First version publication date |
31 Mar 2019
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
THR-317-001
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT03071068 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
ThromboGenics NV
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Sponsor organisation address |
Gaston Geenslaan 1, Leuven, Belgium, 3001
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Public contact |
Global Clinical Development, ThromboGenics NV, 32 16751310, info@oxurion.com
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Scientific contact |
Global Clinical Development, ThromboGenics NV, 32 16751310, info@oxurion.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
01 Jun 2018
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
11 Apr 2018
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Global end of trial reached? |
Yes
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Global end of trial date |
11 Apr 2018
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To evaluate the safety of 3 intravitreal injections of 2 dose levels of THR-317 (4mg or 8mg) and to assess its efficacy in improving best-corrected visual acuity (BCVA) and reducing central subfield thickness (CST), in subjects with centre-involved DME
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Protection of trial subjects |
All study procedures, including the intravitreal injections, were performed by qualified and trained personnel. Only eligible subjects were enrolled in the study and only subjects who did not meet any withdrawal criteria received repeat injections. All subjects were supervised in the immediate post-injection period with appropriate medical treatment readily available. Subjects were followed up for 3 months after the last intravitreal injection. Adverse events were recorded throughout the study period. At each study visit, a full ophthalmic examination and BCVA assessment was performed.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
22 Dec 2016
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Hungary: 11
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Country: Number of subjects enrolled |
Slovakia: 18
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Country: Number of subjects enrolled |
Czech Republic: 20
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Worldwide total number of subjects |
49
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EEA total number of subjects |
49
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
22
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From 65 to 84 years |
27
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85 years and over |
0
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Recruitment
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Recruitment details |
- | |||||||||||||||
Pre-assignment
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Screening details |
Before enrolment in the study, a Screening Visit took place during which in- and exclusion criteria were checked. | |||||||||||||||
Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | |||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Single blind | |||||||||||||||
Roles blinded |
Subject | |||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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THR-317 4mg | |||||||||||||||
Arm description |
3 intravitreal injections of THR-317 4mg approximately 1 month apart | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
THR-317 4mg
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Investigational medicinal product code |
THR-317
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Other name |
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Pharmaceutical forms |
Concentrate and solvent for solution for injection
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Routes of administration |
Intravitreal use
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Dosage and administration details |
3 intravitreal injections of THR-317 4mg approximately 1 month apart
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Arm title
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THR-317 8mg | |||||||||||||||
Arm description |
3 intravitreal injections of THR-317 8mg approximately 1 month apart | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
THR-317 8mg
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Investigational medicinal product code |
THR-317
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Intravitreal use
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Dosage and administration details |
3 intravitreal injections of THR-317 8mg approximately 1 month apart
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Baseline characteristics reporting groups
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Reporting group title |
THR-317 4mg
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Reporting group description |
3 intravitreal injections of THR-317 4mg approximately 1 month apart | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
THR-317 8mg
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Reporting group description |
3 intravitreal injections of THR-317 8mg approximately 1 month apart | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
THR-317 4mg
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Reporting group description |
3 intravitreal injections of THR-317 4mg approximately 1 month apart | ||
Reporting group title |
THR-317 8mg
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Reporting group description |
3 intravitreal injections of THR-317 8mg approximately 1 month apart |
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End point 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 [1] | |||||||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
up to 7-day follow-up visit after each injection
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of the primary endpoint was descriptive, no statistical hypothesis test was performed. |
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No statistical analyses for this end point |
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End point title |
Incidence of systemic and ocular (S)AEs up to the 30 day follow-up visit, after each injection and across injections per subject | |||||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
up to 30-day follow-up visit after each injection
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No statistical analyses for this end point |
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End point title |
Incidence of systemic and ocular (S)AEs from first injection up to Day 90 and up to Day 150 | |||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
from first injection, up to Day 90 and up to Day 150
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No statistical analyses for this end point |
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End point title |
Number of subjects with a loss of ≥ 15, ≥ 10 or ≥ 5 ETDRS letters in BCVA from baseline by study visit | ||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
at Day 150
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No statistical analyses for this end point |
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End point title |
Number of subjects with an acute loss (up to the 7 day follow-up visit) of ≥ 15, ≥ 10 or ≥ 5 ETDRS letters in BCVA after the first injection | ||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
after the first injection
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No statistical analyses for this end point |
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End point title |
Number of subjects with an acute loss (up to the 7 day follow-up visit) of ≥ 15, ≥ 10 or ≥ 5 ETDRS letters in BCVA after the second injection | ||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
after the second injection
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No statistical analyses for this end point |
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End point title |
Number of subjects with an acute loss (up to the 7 day follow-up visit) of ≥ 15, ≥ 10 or ≥ 5 ETDRS letters in BCVA after the third injection | ||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
after the third injection
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No statistical analyses for this end point |
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End point title |
Number of subjects with a ≥ 15 ETDRS letters gain in BCVA from baseline or ≥ 83 ETDRS letters, by study visit | |||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
at Day 90
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No statistical analyses for this end point |
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End point title |
Mean change from baseline in BCVA, by study visit | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
at Day 90
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No statistical analyses for this end point |
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End point title |
Mean change from baseline in CST, by study visit, based on SD-OCT | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
at Day 90
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No statistical analyses for this end point |
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End point title |
Number of subjects withdrawn from repeat injection | |||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
prior to the second injection and prior to the third injection
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
From first injection up to Day 150
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
20.1
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Reporting groups
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Reporting group title |
THR-317 4mg
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Reporting group description |
3 intravitreal injections of THR-317 4mg approximately 1 month apart | ||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
THR-317 8mg
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Reporting group description |
3 intravitreal injections of THR-317 8mg approximately 1 month apart | ||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |