Clinical Trial Results:
Open extension study for patients with age related macula degeneration who participated in the Fase IV-II clinical trial randomized, simulatedcontrolled treatment to evaluate safety and efficacy of intravitreal etamsilato code OFT-ETAMSILATO -4.2.1
Summary
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EudraCT number |
2014-005556-25 |
Trial protocol |
ES |
Global end of trial date |
15 Sep 2017
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Results information
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Results version number |
v1(current) |
This version publication date |
09 Aug 2018
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First version publication date |
09 Aug 2018
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Other versions |
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Summary report(s) |
Final results report |
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 |
OFT-ETAMSILATO-4.2.2
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Investigacion Independiente
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Sponsor organisation address |
C/ Cuesta del Sagrado Corazón nº 4,, Madrid, Spain, 28016
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Public contact |
Rocio Garcia Cañamaque, Leon Research S.L., 0034 987261 064, rgcanamaque@leonresearch.es
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Scientific contact |
Rocio Garcia Cañamaque, Leon Research S.L., 0034 987261 064, rgcanamaque@leonresearch.es
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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 Sep 2017
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
15 Sep 2017
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
Evaluate the effect of treatment received in the previous clinical trial (intravitreal ethamsylate or simulated treatment) in improvement of the visual acuity in patients diagnosed with dry or wet aged related macular degeneration disease after a non-interventionist tracking "treated eye" in the clinical trial until the week 48 of the double blinded treatment administration. This objective will be valued only in patients not receiving intravitreal ethamsylate in the extension study.
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Protection of trial subjects |
To avoid having discomfort or pain with the injection in the eye (intravitreal), an anesthetic eye drop will
be applied. Thus, the patient will not feel any pain or discomfort (PATIENTS WILL NOT BE ABLE TO
DISTINGUISH IF THEY RECEIVE A REAL OR SIMULATED INJECTION)
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Apr 2016
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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 |
Spain: 44
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Worldwide total number of subjects |
44
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EEA total number of subjects |
44
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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) |
5
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From 65 to 84 years |
30
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85 years and over |
9
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Recruitment
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Recruitment details |
The present report presents the clinical results of a complete study, including three clinical trials, with patients recruited in a period of 24 months approximately. The PI will recruit patients, in chronological order according to their private consultation, when they meet the selection criteria specified in the study protocol. | ||||||||||||||||||
Pre-assignment
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Screening details |
Patients who are included in the study MUST meet all the inclusion criteria and MUST NOT present any of the exclusion criteria. Database includes 48 patients, of which 4 of them were finally not considered as they were screen failures. | ||||||||||||||||||
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 |
Double blind | ||||||||||||||||||
Roles blinded |
Subject, Investigator | ||||||||||||||||||
Blinding implementation details |
Patients will not know what treatment they receive. In the control group, the specialist will simulate
giving them the injection, using a blunt needle that does not penetrate the eyeball.
The specialist who evaluates the patients (interpreting the data required for this study) will not know
what treatment each patient has received. Therefore, it is not the same specialist who administers the
treatments, since he / she would know which injections are real or which are feigned.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Treatment | ||||||||||||||||||
Arm description |
Patients receive etamsylate administration | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
DICYNONE 250 mg/2 ml
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Investigational medicinal product code |
PRD437914
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Other name |
B02BX01
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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 |
A single intravitreal injection of 18.75 mg of etamsylate (150 μL)
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Arm title
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Control | ||||||||||||||||||
Arm description |
The specialist will simulate giving patients the injection, using a blunt needle that does not penetrate the eyeball | ||||||||||||||||||
Arm type |
No intervention | ||||||||||||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Baseline characteristics reporting groups
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Reporting group title |
Treatment
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Reporting group description |
Patients receive etamsylate administration | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Control
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Reporting group description |
The specialist will simulate giving patients the injection, using a blunt needle that does not penetrate the eyeball | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Treatment
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Reporting group description |
Patients receive etamsylate administration | ||
Reporting group title |
Control
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Reporting group description |
The specialist will simulate giving patients the injection, using a blunt needle that does not penetrate the eyeball | ||
Subject analysis set title |
Safety
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
During the entire study, only one patient presented an Adverse Event (control group): elevated
intraocular pressure
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Subject analysis set title |
Analysis group by intention to treat
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Subject analysis set type |
Intention-to-treat | ||
Subject analysis set description |
valid assessment of visual acuity.
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Subject analysis set title |
Per protocol
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
There are a large number of patients with significant deviations, so we have to work with the analysis
group per protocol, evaluable patients who meet the inclusion criteria and perform a valid follow-up
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End point title |
Efficacy at 4 weeks | |||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
To establish efficacy at 4 weeks of a single intravitreal injection of etamsylate in the improvement of
visual acuity in patients diagnosed with dry or exudative DMAE
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Statistical analysis title |
Chi-Squared | |||||||||||||||
Statistical analysis description |
The "treatment success" is defined as the improvement of the best corrected visual acuity of 1 or more
letters in the ETDRS optotype in relation to the baseline value.
"Treatment failure" is defined as opposed to "treatment success" as the absence of changes in the best
corrected visual acuity or the loss of 1 or more letters in the ETDRS optotype in relation to the baseline
value.
Efficacy is assessed in relation to the proportion of patients who present "treatment success" in week 4
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Comparison groups |
Treatment v Control
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Number of subjects included in analysis |
31
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Analysis specification |
Pre-specified
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Analysis type |
other [1] | |||||||||||||||
P-value |
= 0.025 | |||||||||||||||
Method |
Chi-squared | |||||||||||||||
Parameter type |
Proportion | |||||||||||||||
Confidence interval |
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Notes [1] - If only the superiority of etamsylate can be demonstrated by proportion of successes, the result of the study will be considered positive. |
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End point title |
efficacy at 16 weeks | |||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Evaluate the efficacy at 16 weeks of a single intravitreal injection of etamsylate in improving visual
acuity in patients diagnosed with dry or exudative AMD
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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 |
Throughout the duration of the study
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Assessment type |
Non-systematic | ||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||
Dictionary version |
18.0
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Reporting groups
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Reporting group title |
overall study
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Reporting group description |
- | ||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 0.02% | |||||||||||||||||
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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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04 Jan 2016 |
Reduction of visits |
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01 Dec 2016 |
change of objectives and inclusion criteria |
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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. | |||
None reported |