Clinical Trial Results:
Early treatment of patients with central serous retinopathy:
A randomized controlled trial
Summary
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EudraCT number |
2009-017959-98 |
Trial protocol |
NL |
Global end of trial date |
04 Jul 2018
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Results information
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Results version number |
v2(current) |
This version publication date |
23 Dec 2020
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First version publication date |
23 Aug 2018
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Other versions |
v1 |
Version creation reason |
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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 |
OZR-2009-26
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Other trial identifiers |
Nederlands Trial Register: NTR2261 | ||
Sponsors
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Sponsor organisation name |
Rotterdam Eye Hospital
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Sponsor organisation address |
PO Box 70030, Rotterdam, Netherlands, 3000LM
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Public contact |
Rotterdam Ophthalmic Institute, The Rotterdam Eye Hospital, 31 (0)104023449, roi@oogziekenhuis.nl
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Scientific contact |
Rotterdam Ophthalmic Institut, Rotterdam Ophthalmic Institute The Rotterdam Eye Hospital, 31 (0)104023449, roi@oogziekenhuis.nl
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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 |
30 Jul 2018
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
04 Jul 2018
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Global end of trial reached? |
Yes
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Global end of trial date |
04 Jul 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 determine the outcome in CSR patients comparing treatment with PDT versus observation.
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Protection of trial subjects |
No specific measures.
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Background therapy |
There is no agreement concerning the early treatment of central serous retinopathy (CSR). In literature, clinical case series using photodynamic therapy (PDT) show favorable results. In this study patients were randomized between an observational and an early PDT treatment arm. In the observational arm, patients with persistent lesions at 3 months were treated with PDT in agreement with current standard of care. | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
24 Aug 2010
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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 |
Netherlands: 52
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Worldwide total number of subjects |
52
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EEA total number of subjects |
52
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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) |
52
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Patients presenting with CSR with poor prognostic factors. | |||||||||||||||
Pre-assignment
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Screening details |
No previous history of CSR in either eye. Poor prognostic acute CSR with at least one of the following lesion characteristics: 1) initial localization within 1 disk diameter of the fovea, 2) number of lesions 3 or more, 3) total lesion surface 1 disk area or more. | |||||||||||||||
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 |
Yes
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Arm title
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Control | |||||||||||||||
Arm description |
No immediate treatment | |||||||||||||||
Arm type |
No intervention | |||||||||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Arm title
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Active | |||||||||||||||
Arm description |
Immediate PDT. | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
Photodynamic therapy (Visudyne)
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Investigational medicinal product code |
Visudyne
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Other name |
verteporfine
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Pharmaceutical forms |
Injection
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Routes of administration |
Intravenous use
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Dosage and administration details |
Body weight corrected dose, single administration
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Baseline characteristics reporting groups
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Reporting group title |
Control
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Reporting group description |
No immediate treatment | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Active
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Reporting group description |
Immediate PDT. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Control
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Reporting group description |
No immediate treatment | ||
Reporting group title |
Active
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Reporting group description |
Immediate PDT. |
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End point title |
Visual acuity at 12 months | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Visual acuity at 12 months
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Statistical analysis title |
Comparison | ||||||||||||
Statistical analysis description |
Independent t-test
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Comparison groups |
Control v Active
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Number of subjects included in analysis |
43
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Confidence interval |
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Variability estimate |
Standard deviation
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End point title |
Visual acuity change at 3 months | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Visual acuity change from baseline to 3 months
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No statistical analyses for this end point |
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End point title |
Central foveal thickness change at 3 months | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Central foveal thickness change from baseline to 3 months
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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 |
12 months
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Assessment type |
Systematic | ||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||
Dictionary version |
21
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Frequency threshold for reporting non-serious adverse events: 5% | |||
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: Adverse events were not reported. |
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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 | |||
Online references |
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http://www.ncbi.nlm.nih.gov/pubmed/32264706 |