Clinical Trial Results:
fMRI analysis of the visual cortex in neovascular Age-related Macular Degeneration
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Summary
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EudraCT number |
2013-004769-15 |
Trial protocol |
AT |
Global end of trial date |
17 Dec 2018
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Results information
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Results version number |
v1(current) |
This version publication date |
23 May 2020
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First version publication date |
23 May 2020
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Other versions |
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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 |
V1.2
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Medical University of Vienna
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Sponsor organisation address |
Währinger Gürtel 18-20, Wien, Austria, 1090
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Public contact |
Vienna Study Center, Universitätsklinik für Augenheilkunde, Medizinische Universität Wien, 0043 1404004847, renate.baltas@meduniwien.ac.at
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Scientific contact |
Vienna Study Center, Universitätsklinik für Augenheilkunde, Medizinische Universität Wien, 4040048471 1404004847, renate.baltas@meduniwien.ac.at
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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 |
17 Dec 2019
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
17 Dec 2018
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Global end of trial reached? |
Yes
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Global end of trial date |
17 Dec 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 activation pattern of the primary visual cortex in nAMD patients before and after ranibizumab therapy and to compare it with healthy controls.
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Protection of trial subjects |
Ranibizumab intravitreal injections were administered according to the label. Patient safety standards of the Dept. of Ophthalmology of the Medical University of Vienna were applied.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
16 Dec 2013
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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 |
Austria: 41
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Worldwide total number of subjects |
41
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EEA total number of subjects |
41
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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 |
37
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85 years and over |
2
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Recruitment
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Recruitment details |
- | |||||||||
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Pre-assignment
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Screening details |
Twenty eyes of 20 patients with treatment-naïve nAMD were recruited for this study | |||||||||
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Pre-assignment period milestones
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Number of subjects started |
41 | |||||||||
Number of subjects completed |
41 | |||||||||
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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 |
Not applicable
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Blinding used |
Not blinded | |||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Treatment group | |||||||||
Arm description |
Patients with treatment naive neovascular age-related macular degeneration were treated with 3 monthly intravitreal injections of Ranibizumab. | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Lucentis
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Investigational medicinal product code |
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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 |
0,05 mL (=0,5mg) Ranibizumab
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Arm title
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Control group | |||||||||
Arm description |
Healthy age-matched controls | |||||||||
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 (overall period)
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Treatment group
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Reporting group description |
Patients with treatment naive neovascular age-related macular degeneration were treated with 3 monthly intravitreal injections of Ranibizumab. | ||
Reporting group title |
Control group
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Reporting group description |
Healthy age-matched controls | ||
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End point title |
Functional magnetic resonance imaging [1] | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Baseline vs 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: In order to visualise the difference of active voxels numbers when comparing baseline and month 3 runs, data of all subjects were combined and visualised through a histogram in visual field space. The inner 9.4° visual angle were separated into nine concentric annuli and a central disk. The relative change of suprathreshold pRF centre voxel numbers inside these annuli were then compared for baseline and post-ranibizumab loading dose runs over all patients. |
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| No statistical analyses for this end point | |||||||||||||
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Adverse events information [1]
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Timeframe for reporting adverse events |
During treatment phase for each patient.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||
Dictionary version |
17
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Reporting groups
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Reporting group title |
Patients
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||
| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: No non-serious adverse event was recorded |
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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 | |||
