Clinical Trial Results:
Individualizing therapy for neovascular age-related macular degeneration with aflibercept
|
Summary
|
|
EudraCT number |
2014-002381-73 |
Trial protocol |
GB |
Global end of trial date |
26 Jan 2018
|
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
20 Nov 2019
|
First version publication date |
20 Nov 2019
|
Other versions |
|
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
|
|||
|
Trial identification
|
|||
Sponsor protocol code |
PATP1023
|
||
|
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
NCT02441816 | ||
WHO universal trial number (UTN) |
- | ||
|
Sponsors
|
|||
Sponsor organisation name |
Moorfields Eye Hospital NHS Foundation Trust
|
||
Sponsor organisation address |
162 City Road, London, United Kingdom, EC1V 2PD
|
||
Public contact |
Tania West, Moorfields Eye Hospital, +44 02072533411,
|
||
Scientific contact |
Tania West, Moorfields Eye Hospital, +44 02072533411, moorfields.resadmin@nhs.net
|
||
|
Paediatric regulatory details
|
|||
Is trial part of an agreed paediatric investigation plan (PIP) |
No
|
||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
|
Results analysis stage
|
|||
Analysis stage |
Final
|
||
Date of interim/final analysis |
17 Apr 2018
|
||
Is this the analysis of the primary completion data? |
Yes
|
||
Primary completion date |
26 Jan 2018
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
26 Jan 2018
|
||
Was the trial ended prematurely? |
No
|
||
|
General information about the trial
|
|||
Main objective of the trial |
Our primary aim is to estimate the average change in vision function in eyes treated with aflibercept.
|
||
Protection of trial subjects |
In line with standard care, topical anaesthetic was used prior to aflibercept injection treatment. Non-study eye was treated in accordance with NHS standards of care and was monitored throughout the study.
|
||
Background therapy |
Treatment to the non-study eye could continue throughout the study. Patients had not received prior treatment for wet age-related macular degeneration in the study eye. | ||
Evidence for comparator |
The study drug was not compared to another drug during this trial | ||
Actual start date of recruitment |
01 Dec 2014
|
||
Long term follow-up planned |
No
|
||
Independent data monitoring committee (IDMC) involvement? |
No
|
||
|
Population of trial subjects
|
|||
Number of subjects enrolled per country |
|||
Country: Number of subjects enrolled |
United Kingdom: 50
|
||
Worldwide total number of subjects |
50
|
||
EEA total number of subjects |
50
|
||
Number of subjects enrolled per age group |
|||
In utero |
0
|
||
Preterm newborn - gestational age < 37 wk |
0
|
||
Newborns (0-27 days) |
0
|
||
Infants and toddlers (28 days-23 months) |
0
|
||
Children (2-11 years) |
0
|
||
Adolescents (12-17 years) |
0
|
||
Adults (18-64 years) |
3
|
||
From 65 to 84 years |
39
|
||
85 years and over |
8
|
||
|
|||||||||||
|
Recruitment
|
|||||||||||
Recruitment details |
Between 24 November Between 24 November 2014 to 17 March 2016 to 17 March 2016 we recruited 50 patients with wet age-related macular degeneration to the study. The patients were recruited from clinics at Moorfields Eye Hospital. | ||||||||||
|
Pre-assignment
|
|||||||||||
Screening details |
84 patients were potentially suitable for the study. 16 refused to take part, 68 patients were screened for the study. | ||||||||||
|
Period 1
|
|||||||||||
Period 1 title |
overall trial (overall period)
|
||||||||||
Is this the baseline period? |
Yes | ||||||||||
Allocation method |
Not applicable
|
||||||||||
Blinding used |
Not blinded | ||||||||||
Blinding implementation details |
not blinded
|
||||||||||
|
Arms
|
|||||||||||
|
Arm title
|
aflibercept treatment | ||||||||||
Arm description |
Intravitreal aflibercept for wet (neovascular) age-related macular degeneration | ||||||||||
Arm type |
Experimental | ||||||||||
Investigational medicinal product name |
aflibercept
|
||||||||||
Investigational medicinal product code |
|||||||||||
Other name |
|||||||||||
Pharmaceutical forms |
Concentrate for solution for injection
|
||||||||||
Routes of administration |
Intravitreal use
|
||||||||||
Dosage and administration details |
Eylea solution is supplied in a vial (40mg/ml). Each vial contains 100 microlitres, equivalent to 4 mg aflibercept. This provides a usable amount to deliver a single dose of 50 microlitres containing 2 mg aflibercept. The dose used in this trial will be 0.05ml (2mg) per intravitreal injection.
|
||||||||||
|
|||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Baseline characteristics reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
overall trial
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||
|
End points reporting groups
|
|||
Reporting group title |
aflibercept treatment
|
||
Reporting group description |
Intravitreal aflibercept for wet (neovascular) age-related macular degeneration | ||
|
|||||||||
End point title |
Mean change in visual acuity at 24 months from baseline [1] | ||||||||
End point description |
Mean change in visual acuity at 24 months from baseline
|
||||||||
End point type |
Primary
|
||||||||
End point timeframe |
24 months
|
||||||||
| 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: there was no comparator arm so no statistical test was carried out |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Adverse events information [1]
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
SAE/SUSAR reporting as per the protocol
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Dictionary used for adverse event reporting
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary name |
bayer plc | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
2015
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
aflibercept treated patients
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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 events have been recorded. All events recorded are serious adverse events |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Frequency threshold for reporting non-serious adverse events: 1% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||
Substantial protocol amendments (globally) |
|||
| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
||
22 Dec 2014 |
Protocol updated as Levofloxacin no longer standard of care |
||
07 Dec 2015 |
Update to eligibility criteria for study eyes - clarification of one of the inclusion criteria relating to the size of the wet AMD lesion.
Addition of several secondary and exploratory outcomes to the protocol.
Clarification of when optometrists may wish to re-refract patients at an un-refracted vision study visit.
In line with standard care at our Trust, the option to use nursing staff for delivery of Eylea intravitreal injections has been added to the protocol.
Clarification on the reporting requirements for systemic and ocular events in the safety section of the protocol.
Change to the trial specific monitoring plan. |
||
Interruptions (globally) |
|||
| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
