Clinical Trial Results:
Intravitreal Aflibercept treatment in RAP-Lesions, PED, hemorrhagic CNV and PCV
Summary
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EudraCT number |
2014-002384-15 |
Trial protocol |
AT |
Global end of trial date |
30 Apr 2018
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Results information
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Results version number |
v1(current) |
This version publication date |
16 Nov 2019
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First version publication date |
16 Nov 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 |
3.0
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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 |
Medical University of Vienna
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Sponsor organisation address |
Spitalgasse 23, Vienna, Austria, 1090
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Public contact |
MUW, Universitätsklinik für Augenheilkunde und Optometrie, Medizinische Universität Wien, +43 14040079310, stefan.sacu@meduniwien.ac.at
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Scientific contact |
MUW, Universitätsklinik für Augenheilkunde und Optometrie, Medizinische Universität Wien, +43 14040079310, stefan.sacu@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 |
Interim
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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? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
30 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 investigate the effect of intravitreal Aflibercept treatment on the visual outcome in patient with exsudative maculopathies such as Rap-lesions, PED, hemorrhagic CNV and PCV.
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Protection of trial subjects |
Intravitreal aflibercept therapy is considered to be safe. As with every intravitreal form of therapy, the potential for post-injection IOP elevation, endophthalmitis, cataract, hemorrhage, rhegmatogenous retinal detachment or proliferative vitreoretinopathy must be considered. However, all of these side effects have an incidence of less than 1% of all
treatments.
After intravitreal injections, visual acuity of patient will be checked (e.g. hand motion, counting fingers) to avoid unacceptable IOP elevations and ensure ocular perfusion-in cases of blocked ocular perfusion (i.e. the patient is unable to recognize hand motion/finger counting), a paracentesis will be performed by the surgeon
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Background therapy |
- | ||
Evidence for comparator |
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Actual start date of recruitment |
03 Nov 2014
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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: 50
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Worldwide total number of subjects |
50
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EEA total number of subjects |
50
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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) |
3
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From 65 to 84 years |
35
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85 years and over |
12
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Recruitment
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Recruitment details |
- | ||||||||||
Pre-assignment
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Screening details |
Fifty patients will be enrolled in the study. The population will consist patients over 50 years of age with treatment naïve, RAP-lesions, PED, hemorrhagic CNV and polypoidal choroidal vasculopathy. | ||||||||||
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 | ||||||||||
Arms
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Arm title
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All Patients | ||||||||||
Arm description |
Evaluation of intravitreal aflibercept (Eylea®, Bayer) on oxygen saturatin and clinical outcomes in eyes with RAP-lesions, PED, hemorrhagic CNV or PCV. | ||||||||||
Arm type |
Intervention | ||||||||||
Investigational medicinal product name |
Intravitreal aflibercept
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection in pre-filled syringe
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Routes of administration |
Intravitreal use
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Dosage and administration details |
2mg/0.05ml
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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 |
All Patients
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Reporting group description |
Evaluation of intravitreal aflibercept (Eylea®, Bayer) on oxygen saturatin and clinical outcomes in eyes with RAP-lesions, PED, hemorrhagic CNV or PCV. |
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End point title |
Oxygen saturation of retinal vessels [1] | ||||||
End point description |
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End point type |
Primary
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End point timeframe |
12 months
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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: Anova and the paired t-test was performed to investigate the longitudinal changes in visual acuity, the central retinal thickness, retinal vessel diameters, retrobulbar flow velocities and retinal blood flow. A p-value ≤0.05 is considered as statistical significant. Descriptive analysis will be performed for patient´s demographic data, furthermore, chi²-Test was used for nominal parameters. |
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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 |
Adverse events, serious adverse events are collected by spontaneous reporting during the study period. Nonserious adverse events and SUSARs are documented on an "Adverse event" page in the case record form.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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 |
Aflibercept
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Reporting group description |
ntravitreal aflibercept treatment will be performed identically under sterile conditions in the surgery room as follows: 0,5ml of 2 mg of commercially available aflibercept (Eylea®; Bayer) will be applied intravitreal through the pars plana using a 30-gauge needle | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 4% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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 |