Clinical Trial Results:
Treatment of retinal angiomatous proliferation lesions due to age-related macular degeneration with ranibizumab (Lucentis®) and photodynamic therapy with verteporfin (Visudyne®)
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Summary
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EudraCT number |
2006-004367-57 |
Trial protocol |
AT |
Global end of trial date |
31 Jul 2009
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Results information
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Results version number |
v1(current) |
This version publication date |
13 Jul 2024
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First version publication date |
13 Jul 2024
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Other versions |
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Summary report(s) |
Publication |
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 |
n/a
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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 Graz Deparment of ophthalmology
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Sponsor organisation address |
Auenbruggerplatz 4, Graz, Austria,
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Public contact |
Anton Haas, Medical University Graz Deparment of ophthalmology, anton.haas@medunigraz.at
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Scientific contact |
Anton Haas, Medical University Graz Deparment of ophthalmology, anton.haas@medunigraz.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 |
01 Jun 2012
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
31 Jul 2009
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Global end of trial reached? |
Yes
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Global end of trial date |
31 Jul 2009
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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 |
This case-series is designed to evaluate the safety and efficacy of intravitreal ranibizumab (Lucentis®) used in combination with verteporfin photodynamic therapy (Visudyne®) in the treatment of sub- and juxtafoveal retinal angiomatous proliferations (RAP) secondary to AMD.
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Protection of trial subjects |
The study was approved by the local ethics committee and was conducted in accordance with the Declaration of Helsinki. All patients provided written consent.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Jul 2008
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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: 15
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Worldwide total number of subjects |
15
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EEA total number of subjects |
15
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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) |
0
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From 65 to 84 years |
15
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85 years and over |
0
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Recruitment
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Recruitment details |
The present prospective study comprised 15 patients with RAP, who were included between July 2008 and July 2009 at the Department of Ophthalmology of the Medical University of Graz ⁄Austria. | ||||||||||
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Pre-assignment
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Screening details |
Inclusion criteria for the study were the presence of treatment-naıve RAP at any stage and a best-corrected visual acuity (BCVA) in the affected eye between 24 and 73 letters. RAP lesions only less or equal to 5400 lm in greatest linear dimension and and lying within 200 µm of the geometric centre of the foveal avascular zone were included. | ||||||||||
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Pre-assignment period milestones
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Number of subjects started |
15 | ||||||||||
Number of subjects completed |
15 | ||||||||||
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Period 1
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Period 1 title |
Baseline Period (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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Arm title
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Patients wit retinal angiomatous proliferation | ||||||||||
Arm description |
All patients who met the study criteria and consented to participate in the study were scheduled for baseline examination. Within 7 days after examination, every patient received verteporfin photodynamic therapy according to the standard protocol as described by the TAP study group (1999). This was followed by an intravitreal injection of 0.5-mg ranibizumab the next day. The regimen included additional injections of 0.5-mg ranibizumab both 1 and 2 months after the first treatment. After that, patients received intravitreal ranibizumab injections according to a PRN regime. | ||||||||||
Arm type |
Experimental | ||||||||||
Investigational medicinal product name |
Verteporfin photodynamic therapy
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for solution for injection
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Routes of administration |
Intravenous use
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Dosage and administration details |
Verteporfin photodynamic therapy according to the standard protocol as described by the TAP study group (1999)
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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/infusion in pre-filled syringe
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Routes of administration |
Intravitreal use
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Dosage and administration details |
3 intravitreal injection of 0.5-mg ranibizumab at baseline, month 1 and month 2, after that PRN regime till month 12
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Baseline characteristics reporting groups
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Reporting group title |
Baseline Period
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Reporting group description |
n/a | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Patients wit retinal angiomatous proliferation
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Reporting group description |
All patients who met the study criteria and consented to participate in the study were scheduled for baseline examination. Within 7 days after examination, every patient received verteporfin photodynamic therapy according to the standard protocol as described by the TAP study group (1999). This was followed by an intravitreal injection of 0.5-mg ranibizumab the next day. The regimen included additional injections of 0.5-mg ranibizumab both 1 and 2 months after the first treatment. After that, patients received intravitreal ranibizumab injections according to a PRN regime. | ||
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End point title |
Change in BCVA between baseline and month 12 [1] | ||||||||
End point description |
The primary end-point was the change in BCVA between baseline and month 12.
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End point type |
Primary
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End point timeframe |
Baseline, Month 12
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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: Single arm study, not possible to enter statistical analysis in the system. See summary attachment for statistical analysis |
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| No statistical analyses for this end point | |||||||||
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End point title |
Change in BCVA between baseline and month 6 | ||||||||
End point description |
Secondary end-points included the mean change in BCVA between baseline and month 6
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End point type |
Secondary
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End point timeframe |
Baseline, Month 6
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| No statistical analyses for this end point | |||||||||
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End point title |
Proportion of patients with a gain of >5 letters, >10 letters and >15 letters at month 6 | ||||||||||||
End point description |
Proportion of patients with a gain of 5, 10 or 15 letters
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End point type |
Secondary
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End point timeframe |
6 month
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Proportion of patients with a gain of >5 letters, >10 letters and >15 letters at month 12 | ||||||||||||
End point description |
Proportion of patients with a gain of 5, 10 or 15 letters at month 12
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End point type |
Secondary
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End point timeframe |
Month 12
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Mean injections month 6 and month 12 | ||||||||||||
End point description |
Total number of treatments, mean injections in No. (min/max)
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End point type |
Secondary
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End point timeframe |
Month 6, Month 12
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Proportion of patients with a loss of 15 letters at month 6 and month 12 | ||||||||||
End point description |
Proportion of patients with a loss of 15 letters at month 6 and month 12
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End point type |
Secondary
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End point timeframe |
Month 6 and Month 12
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| No statistical analyses for this end point | |||||||||||
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End point title |
Mean Time to first retreatment following the initial loading dose | ||||||||
End point description |
Mean Time to first retreatment following the initial loading dose
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End point type |
Secondary
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End point timeframe |
monthly
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| No statistical analyses for this end point | |||||||||
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End point title |
Mean change in foveal thickness on OCT at month 6 and month 12 | ||||||||||||
End point description |
Mean change in foveal thickness on OCT
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End point type |
Secondary
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End point timeframe |
monthly
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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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Adverse event reporting additional description |
n/a
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Assessment type |
Systematic | ||
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Dictionary used for adverse event reporting
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Dictionary name |
n/a | ||
Dictionary version |
n/a
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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: no AE or SAE occurred |
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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 | |||
