Clinical Trial Results:
Management of recurrent or persistent choroidal neovascularization secondary to age-related macular degeneration
A prospective, randomized, clinical study
Summary
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EudraCT number |
2010-021923-29 |
Trial protocol |
AT |
Global end of trial date |
28 Nov 2013
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Results information
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Results version number |
v1(current) |
This version publication date |
04 Jan 2020
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First version publication date |
04 Jan 2020
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Other versions |
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Summary report(s) |
Synopsis |
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 |
10032011
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01162746 | ||
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, 1090 Vienna, Austria,
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Public contact |
Department of Ophthalmology and Optometry, Medical University of Vienna, Austria, +43 14040079310, ophthalmology@meduniwien.ac.at
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Scientific contact |
Department of Ophthalmology and Optometry, Medical University of Vienna, Austria, +43 14040079310, ophthalmology@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 |
Final
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Date of interim/final analysis |
31 Jul 2014
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
28 Nov 2013
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Global end of trial reached? |
Yes
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Global end of trial date |
28 Nov 2013
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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 assess the treatment effect of intravitreal dexamethasone and ranibizumab versus ranibizumab monotherapy in patients with persistent or recurrent CNV due to AMD.
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Protection of trial subjects |
Safety of the combined treatments has been assessed previously. Intraocular pressure (IOP) elevation is the most common complication after intravitreal dexamethasone application. The potential for post-injection endophthalmitis, hemorrhage, cataract, rhegmatogenous retinal detachment or proliferative vitreoretinopathy must also be considered with this treatment. However, all of these side effects are assumed to occur in less than 1% of all treatments. Since the treatment and the measuring procedures used in this study are well tolerated in standard clinical practice, the benefit/risk ratio appears acceptable.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Aug 2011
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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: 40
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Worldwide total number of subjects |
40
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EEA total number of subjects |
40
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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 |
37
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85 years and over |
3
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Recruitment
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Recruitment details |
- | |||||||||
Pre-assignment
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Screening details |
- | |||||||||
Pre-assignment period milestones
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Number of subjects started |
40 | |||||||||
Number of subjects completed |
40 | |||||||||
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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Combination therapy | |||||||||
Arm description |
Patients within this cohort will receive intravitreal dexamethasone using a special drug delivery system and same day intravitreal ranibizumab (cohort 1). | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Dexamethasone and ranibizumab
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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, Implant in pre-filled syringe
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Routes of administration |
Intravitreal use
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Dosage and administration details |
Patients in cohort 1 will receive an applicator for an intravitreal dexamethasone drug delivery system under sterile conditions in the surgery room as follows: Patients will have the dexamethasone drug delivery system (0.7 mg, Ozurdex; Allergan Inc.) inserted into the vitreous base through the pars plana. The applicator placement system consists of a sterile, single-use instrument that delivers one preloaded dose of dexamethasone DDS into the vitreous humor via a 22-gauge needle.
Intravitreal ranibizumab treatment will be performed under sterile conditions in the surgery room as follows: 0.5 mg of commercially available ranibizumab (Lucentis; Novartis Ophthalmics) will be applied intravitreally through the pars plana using a 30-gauge needle.
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Arm title
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Ranibizumab | |||||||||
Arm description |
- | |||||||||
Arm type |
Active comparator | |||||||||
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 in pre-filled syringe
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Routes of administration |
Intravitreal use
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Dosage and administration details |
Intravitreal ranibizumab treatment will be performed under sterile conditions in the surgery room as follows: 0.5 mg of commercially available ranibizumab (Lucentis; Novartis Ophthalmics) will be applied intravitreally through the pars plana using a 30-gauge needle.
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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 |
Combination therapy
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Reporting group description |
Patients within this cohort will receive intravitreal dexamethasone using a special drug delivery system and same day intravitreal ranibizumab (cohort 1). | ||
Reporting group title |
Ranibizumab
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Reporting group description |
- |
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End point title |
Visual acuity | |||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Baseline - month 12
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Statistical analysis title |
t-test | |||||||||
Comparison groups |
Combination therapy v Ranibizumab
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Number of subjects included in analysis |
40
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority | |||||||||
P-value |
< 0.05 | |||||||||
Method |
t-test, 2-sided | |||||||||
Confidence interval |
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Adverse events information
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Timeframe for reporting adverse events |
All serious adverse events which occur during this study, whether considered to be associated with the study medication or not, must be documented on an "Adverse event" page in the case record form. All serious adverse events will be immediatly reported.
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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 |
Ocular
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Reporting group description |
- | ||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||
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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 |