Clinical Trial Results:
A Phase 2, randomised, single-masked, active-controlled, multicentre study to evaluate the efficacy and safety of intravitreal THR-317 administered in combination with ranibizumab, for the treatment of diabetic macular oedema (DME)
Summary
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EudraCT number |
2017-003897-15 |
Trial protocol |
FR GB SK ES DE BE |
Global end of trial date |
18 Jul 2019
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Results information
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Results version number |
v1(current) |
This version publication date |
25 Jul 2020
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First version publication date |
25 Jul 2020
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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-317-002
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT03499223 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Oxurion NV
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Sponsor organisation address |
Gaston Geenslaan 1, Leuven, Belgium, 3001
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Public contact |
Global Clinical Development, Oxurion NV, 32 16751310, info@oxurion.com
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Scientific contact |
Global Clinical Development, Oxurion 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 |
02 Sep 2019
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
18 Jul 2019
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Global end of trial reached? |
Yes
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Global end of trial date |
18 Jul 2019
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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 efficacy and safety of THR-317 administered in combination with ranibizumab, in subjects with central-involved DME (CI-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 study treatment. All subjects were supervised in the immediate post-treatment period with appropriate medical treatment readily available. Subjects were followed for 3 months after the last study treatment. Adverse events were recorded throughout the study period. At each study visit, a full ophthalmic examination and BCVA assessment were performed.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
20 Apr 2018
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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 |
Slovakia: 26
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Country: Number of subjects enrolled |
Spain: 20
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Country: Number of subjects enrolled |
United Kingdom: 9
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Country: Number of subjects enrolled |
France: 9
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Country: Number of subjects enrolled |
Germany: 6
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Worldwide total number of subjects |
70
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EEA total number of subjects |
70
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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) |
34
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From 65 to 84 years |
36
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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 |
The study included a Screening visit during which in- and exclusion criteria were checked | ||||||||||||||||||||||||
Period 1
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Period 1 title |
Overall Trial (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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Ranibizumab + THR-317 | ||||||||||||||||||||||||
Arm description |
Subjects received intravitreal ranibizumab in combination with intravitreal THR-317 | ||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||
Investigational medicinal product name |
Ranibizumab 0.5mg
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Investigational medicinal product code |
Ranibizumab
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Other name |
Lucentis
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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 |
intravitreal ranibizumab 0.5mg at Day 0, Month 1 and Month 2
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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 |
intravitreal THR-317 8mg at Day 0, Month 1 and Month 2
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Arm title
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Sham + ranibizumab | ||||||||||||||||||||||||
Arm description |
Subjects received a sham injection in combination with intravitreal ranibizumab | ||||||||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||||||||
Investigational medicinal product name |
Ranibizumab 0.5mg
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Investigational medicinal product code |
Ranibizumab
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Other name |
Lucentis
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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 |
intravitreal ranibizumab 0.5mg at Day 0, Month 1 and Month 2
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Baseline characteristics reporting groups
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Reporting group title |
Ranibizumab + THR-317
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Reporting group description |
Subjects received intravitreal ranibizumab in combination with intravitreal THR-317 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Sham + ranibizumab
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Reporting group description |
Subjects received a sham injection in combination with intravitreal ranibizumab | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Ranibizumab + THR-317
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Reporting group description |
Subjects received intravitreal ranibizumab in combination with intravitreal THR-317 | ||
Reporting group title |
Sham + ranibizumab
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Reporting group description |
Subjects received a sham injection in combination with intravitreal ranibizumab |
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End point title |
Change from Baseline in best-corrected visual acuity (BCVA) [1] | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Day 84 (Month 3)
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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: No inferential statistics to compare treatment arms 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 (serious) adverse events, from first administration of study treatment up to the end of the study | |||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
From first administration of study treatment up to end of study
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No statistical analyses for this end point |
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End point title |
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 |
Month 5
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No statistical analyses for this end point |
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End point title |
Change from Baseline in central subfield thickness (CST), based on spectral domain optical coherence tomography (SD-OCT), as assessed by the central reading centre (CRC), by study visit | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Day 84 (Month 3)
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No statistical analyses for this end point |
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End point title |
Withdrawal from repeat study treatment and reason for withdrawal | |||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Prior to the second study treatment and prior to the third study treatment
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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 administration of study treatment up to end of study
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Adverse event reporting additional description |
Reported adverse events include all adverse events (including study eye and non-study eye adverse events)
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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 |
Ranibizumab + THR-317
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Reporting group description |
Subjects received intravitreal ranibizumab in combination with intravitreal THR-317 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Sham + ranibizumab
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Reporting group description |
Subjects received a sham injection in combination with intravitreal ranibizumab | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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? Yes | |||
Date |
Amendment |
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25 Sep 2018 |
Addition of visit at Month 4 for better characterisation of the response to treatment. |
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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 |