Clinical Trial Results:
Pilot study on robot assisted retinal vein cannulation with ocriplasmin infusion for central retinal vein occlusion.
Summary
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EudraCT number |
2015-005473-20 |
Trial protocol |
BE |
Global end of trial date |
13 Apr 2017
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Results information
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Results version number |
v1(current) |
This version publication date |
25 Nov 2020
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First version publication date |
25 Nov 2020
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Other versions |
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Summary report(s) |
Publication Acta Ophthalmologica |
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 |
V121102015
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
UZ Leuven Gasthuisberg
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Sponsor organisation address |
Herestraat 49, Leuven, Belgium, 3020
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Public contact |
Peter Stalmans, UZ Leuven, 32 16341819, peter.stalmans@uzleuven.be
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Scientific contact |
Peter Stalmans, UZ Leuven, 32 16341819, peter.stalmans@uzleuven.be
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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 |
13 Apr 2017
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
13 Apr 2017
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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 |
This study aims at investigating the therapeutic effect of local intravenous administration of ocriplasmin in patients with a central retinal vein occlusion. The primary outcome measure is change in visual acuity after 6 months
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Protection of trial subjects |
following standard pre-/per- and post-operative patient care (time-out procedures, sterility checks, postoperative assessments, etc.) safety is monitored and assessed during every foreseen contact with the patient.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Feb 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 |
Belgium: 4
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Worldwide total number of subjects |
4
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EEA total number of subjects |
4
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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) |
2
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From 65 to 84 years |
2
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85 years and over |
0
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Recruitment
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Recruitment details |
patients with recent diagnosis of CRVO | |||||||||
Pre-assignment
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Screening details |
recent diagnosis of CRVO | |||||||||
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 |
Not blinded | |||||||||
Arms
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Are arms mutually exclusive |
No
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Arm title
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first arm | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
ocriplasmin
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Concentrate and solvent for solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
500 µg
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Arm title
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second arm | |||||||||
Arm description |
- | |||||||||
Arm type |
No intervention | |||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Baseline characteristics reporting groups
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Reporting group title |
overall trial
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
first arm
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Reporting group description |
- | ||
Reporting group title |
second arm
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Reporting group description |
- |
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End point title |
change in visual acuity | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
First analysis: 1 month after treatment of the last enrolled patient
Final analysis: 6 months after the last treatment of the last enrolled patient
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Attachments |
acta-10-09 |
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Notes [1] - control group |
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Statistical analysis title |
Robot assisted surgery | ||||||||||||
Statistical analysis description |
Statistical analysis was done using SPSS 24.0.
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Comparison groups |
first arm v second arm
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Number of subjects included in analysis |
5
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Analysis specification |
Pre-specified
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Analysis type |
other [2] | ||||||||||||
P-value |
< 0.05 | ||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||
Parameter type |
mean Standard Deviation | ||||||||||||
Confidence interval |
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Notes [2] - Because of the small amount of data non-parametric related samples, Wilcoxon signed rank tests were used to analyze changes in continuous data. Statistical significance was considered when the two-sided p-value is below 0.05. Values are depicted as mean ±Standard Deviation (SD). |
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Adverse events information
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Timeframe for reporting adverse events |
3 calendar days following the date of awareness by the investigational site study personel
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Assessment type |
Systematic | ||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MEDDEV | ||||||||||||||||||||
Dictionary version |
7
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Reporting groups
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Reporting group title |
single open
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Reporting group description |
- | ||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 3% | |||||||||||||||||||||
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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 |