Clinical Trial Results:
An exploratory study of ranibizumab (Lucentis) for treatment of uveitic patients with refractory cystoid macular oedema. 'The LIMO study'
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Summary
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EudraCT number |
2011-001869-41 |
Trial protocol |
GB |
Global end of trial date |
18 Jun 2014
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Results information
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Results version number |
v1(current) |
This version publication date |
02 Jun 2022
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First version publication date |
02 Jun 2022
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Other versions |
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Summary report(s) |
end of study report Explanation for the post-hoc analysis |
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 |
OKHN1005
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01564108 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Moorfields Eye Hospital NHS Foundation Trust
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Sponsor organisation address |
162 City Road, London, United Kingdom, EC1V 2PD
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Public contact |
Tania West, Moorfields Eye Hospital, 020 72533411, moorfields.resadmin@nhs.net
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Scientific contact |
Tania West, Moorfields Eye Hospital, 020 72533411, moorfields.resadmin@nhs.net
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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 |
03 Nov 2014
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
18 Jun 2014
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Global end of trial reached? |
Yes
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Global end of trial date |
18 Jun 2014
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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 |
Does ranibizumab improve visual outcome in patients with uveitic macular oedema refractory or ineligible for 'standard of care' therapy?
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Protection of trial subjects |
Patients were reviewed at each visit and treatment for uveitis was allowed and instated in case of need.
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Background therapy |
- | ||
Evidence for comparator |
No comparators included in the study | ||
Actual start date of recruitment |
04 Jul 2011
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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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 |
United Kingdom: 10
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Worldwide total number of subjects |
10
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EEA total number of subjects |
10
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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) |
7
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From 65 to 84 years |
3
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85 years and over |
0
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Recruitment
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Recruitment details |
The study was conducted in one single centre, Moorfields Eye Hospital NHS Foundation Trust. The first patient was recruited on the 21st of May 2012 and the last patient was enrolled on the 6th of June 2013. | ||||||
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Pre-assignment
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Screening details |
Patients were identified through uveitis clinics. 21 patients were assessed for eligibility, 11 patients did not meet inclusion/exclusion criteria therefore 10 patients were enrolled in the study. | ||||||
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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 | ||||||
Blinding implementation details |
The study is not blinded - open-label
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Arms
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Arm title
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ranibizumab for uveitic CMO | ||||||
Arm description |
open-label. only arm in the study | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
ranibizumab
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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 |
intravitreal injection of a single dose of 0.05 ml containing 0.5 mg ranibizumab
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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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Subject analysis sets
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Subject analysis set title |
overall cohort
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Subject analysis set type |
Full analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Overall study cohort.
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End points reporting groups
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Reporting group title |
ranibizumab for uveitic CMO
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Reporting group description |
open-label. only arm in the study | ||
Subject analysis set title |
overall cohort
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
Overall study cohort.
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End point title |
the proportion of patients in whom by consensus, no further treatment is required at 6 month | |||||||||
End point description |
the proportion of patients in whom by consensus, no further treatment is required at 6 month
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End point type |
Primary
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End point timeframe |
baseline to 6 month
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Statistical analysis title |
Primary outcome measure 1 at 6 months | |||||||||
Comparison groups |
ranibizumab for uveitic CMO v overall cohort
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Number of subjects included in analysis |
20
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Analysis specification |
Pre-specified
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Analysis type |
other | |||||||||
Method |
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Parameter type |
proportion | |||||||||
Point estimate |
30
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Confidence interval |
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level |
95% | |||||||||
sides |
2-sided
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lower limit |
6.7 | |||||||||
upper limit |
65.2 | |||||||||
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End point title |
the proportion of patients in whom by consensus, no further treatment is required at 12 month | |||||||||
End point description |
the proportion of patients in whom by consensus, no further treatment is required at 12 month
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End point type |
Primary
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End point timeframe |
baseline to 12 month
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Statistical analysis title |
No further treatment required at 12 month | |||||||||
Comparison groups |
ranibizumab for uveitic CMO v overall cohort
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Number of subjects included in analysis |
20
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Analysis specification |
Pre-specified
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Analysis type |
other | |||||||||
Method |
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Parameter type |
proportion | |||||||||
Point estimate |
50
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Confidence interval |
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level |
95% | |||||||||
sides |
2-sided
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lower limit |
18.7 | |||||||||
upper limit |
81.3 | |||||||||
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End point title |
Change in central retinal thickness as measured by Spectralis spectral domain optical coherence tomography in the study eye from baseline to 6 months [1] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
baseline to 6 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: The number and proportion of patients in whom resolution is achieved will be reported and a 95% confidence interval for the proportion will be computed by the exact binomial method. Summary data will be provided for all other study variables using means and SDs or non-parametric equivalents. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Change in central retinal thickness as measured by Spectralis spectral domain optical coherence tomography in the study eye from baseline to 12 months [2] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
baseline to 12 months
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| Notes [2] - 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: The number and proportion of patients in whom resolution is achieved will be reported and a 95% confidence interval for the proportion will be computed by the exact binomial method. Summary data will be provided for all other study variables using means and SDs or non-parametric equivalents. |
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| No statistical analyses for this end point | |||||||||
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End point title |
The proportion of patients in whom by consensus, no further treatment is required at 6 months | |||||||||
End point description |
The proportion of patients in whom by consensus, no further treatment is required at 6 months.
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End point type |
Post-hoc
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End point timeframe |
Baseline to 6 months
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| No statistical analyses for this end point | ||||||||||
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End point title |
The proportion of patients in whom by consensus, no further treatment is required at 12 months | |||||||||
End point description |
The proportion of patients in whom by consensus, no further treatment is required at 12 months
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End point type |
Post-hoc
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End point timeframe |
Baseline to 12 months
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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 |
One year
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
none specific used | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
0
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Reporting groups
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Reporting group title |
All cohort
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Reporting group description |
All the patients enrolled in the study have been included in this group | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 0.05% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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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11 Jan 2013 |
Inclusion criteria to be changed:
a 3 month period post cataract surgery before recruitment rather than 6 months.
RATIONALE: 3 months is the standard period following cataract surgery one would wait in clinical practice before undertaking a further non-urgent intraocular procedure e.g. YAG laser capsulotomy. In addition, waiting 3 months following any intraocular surgery is the period of time now commonly used in studies investigating intravitreal agents, such as this study. Furthermore, macular oedema directly related to surgery would be expected to have resolved within 3 months. |
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18 Jun 2014 |
Amendment to CI of the study
This amendment was submitted before the end of the study (submitted to MHRA on the 14th of May 2014) and was pending when last visit was conducted on the 18th of June 2014. The MHRA was aware of this last visit date, and they approved the substantial amendment on the 31st of July 2014. |
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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. | |||
| A limitation for this study was the limited number of subjects enrolled in the study | |||
