Clinical Trial Results:
A 12-month, Prospective, Open-label, Phase 4 Study to Evaluate the Efficacy and Safety of OZURDEX® (Dexamethasone Intravitreal Implant) in Treatment Naïve Patients (According to Standard Clinical Practice) with Diabetic Macular Edema
Summary
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EudraCT number |
2018-004785-33 |
Trial protocol |
ES |
Global end of trial date |
04 Jul 2022
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Results information
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Results version number |
v2(current) |
This version publication date |
27 Feb 2025
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First version publication date |
14 Jul 2023
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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 |
CMO-MA-EYE-0603
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT03953807 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
AbbVie Deutschland GmbH & Co. KG
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Sponsor organisation address |
AbbVie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire, United Kingdom, SL6 4UB
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Public contact |
AbbVie, Global Medical Services, 001 8006339110, abbvieclinicaltrials@abbvie.com
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Scientific contact |
AbbVie, Global Medical Services, 001 8006339110, abbvieclinicaltrials@abbvie.com
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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 |
04 Jul 2022
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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 |
04 Jul 2022
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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 |
The main objectives of this study were to evaluate the efficacy and safety of OZURDEX in subjects with diabetic macular edema (DME) when used in a real world setting in Spain.
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Protection of trial subjects |
All study subjects were required to read and sign an Informed Consent Form.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
05 Sep 2019
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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: 75
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Country: Number of subjects enrolled |
Portugal: 9
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Worldwide total number of subjects |
84
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EEA total number of subjects |
84
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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) |
31
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From 65 to 84 years |
50
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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 |
A total of 84 subjects were with DME were enrolled to receive the study treatment on Day 1 and were followed up for safety up to 14 months. | ||||||||||||||||||||||||
Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||||||||||
Arms
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Arm title
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OZURDEX® 700 μg | ||||||||||||||||||||||||
Arm description |
Participants enrolled in Spain received OZURDEX® 700 μg intravitreal implant as needed per investigator assessment on Day 1. | ||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||
Investigational medicinal product name |
OZURDEX®
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Investigational medicinal product code |
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Other name |
Dexamethasone Intravitreal Implant
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Pharmaceutical forms |
Implant
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Routes of administration |
Intravitreal use
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Dosage and administration details |
Intravitreal implant administered.
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Baseline characteristics reporting groups
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Reporting group title |
OZURDEX® 700 μg
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Reporting group description |
Participants enrolled in Spain received OZURDEX® 700 μg intravitreal implant as needed per investigator assessment on Day 1. | |||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
OZURDEX® 700 μg
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Reporting group description |
Participants enrolled in Spain received OZURDEX® 700 μg intravitreal implant as needed per investigator assessment on Day 1. |
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End point title |
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at 2 Months After the Last Injection [1] | ||||||||||||
End point description |
BCVA was measured using an eye chart and is reported as the number of letters read correctly using the early treatment diabetic retinopathy study (ETDRS) Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. A positive number indicates improvement. 'n' indicates number of subjects with data available for analysis for the below categories. Full Analysis Set included all enrolled subjects who received >=1 administration of study medication. Study eye = treated eye (with Ozurdex), fellow eye=untreated.
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End point type |
Primary
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End point timeframe |
Baseline to 2 months after the last injection (during Month 10 through 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: This is a single arm study and due to system limitation we were unable to add the statistical analysis. |
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No statistical analyses for this end point |
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End point title |
Mean Change in Central Retinal Thickness (CRT) 2 months (± 2 weeks) After the Last Injection Received [2] | ||||||||||||
End point description |
CRT is defined as the central 1000 microns from the center of the fovea and was measured using spectral domain (SD)-OCT. OCT is a laser-based, non-invasive, diagnostic system providing high-resolution imaging optical sections of the retina. A negative number indicates improvement. 'n' indicates number of subjects with data available for analysis for the below categories. Full Analysis Set included all enrolled subjects who received >=1 administration of study medication.
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End point type |
Primary
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End point timeframe |
Baseline to 2 months after the last injection (during Month 10 through Month 12)
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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: This is a single arm study and due to system limitation we were unable to add the statistical analysis. |
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No statistical analyses for this end point |
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End point title |
Percentage of Subjects With Second Injection | ||||||||
End point description |
Full Analysis Set included all enrolled subjects who received >=1 administration of study medication.
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End point type |
Secondary
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End point timeframe |
Up to Month 14
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No statistical analyses for this end point |
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End point title |
Percentage of Subjects With Third Injection | ||||||||
End point description |
Full Analysis Set included all enrolled subjects who received >=1 administration of study medication.
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End point type |
Secondary
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End point timeframe |
Up to Month 14
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No statistical analyses for this end point |
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End point title |
Mean Retreatment Interval in Study Eye | ||||||||||||
End point description |
First retreatment interval is defined as the number of days between the initial treatment and the first retreatment. Second retreatment interval is defined as the number of days between the first retreatment and the second retreatment. ‘n' indicates number of subjects with data available for analysis for the below categories. Full Analysis Set includes all enrolled subjects who received >=1 administration of study medication. Study eye = treated eye (with Ozurdex), fellow eye=untreated.
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End point type |
Secondary
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End point timeframe |
From initial treatment to the first and second re-treatment to (Up to Month 14)
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No statistical analyses for this end point |
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End point title |
Number of Subjects With Number of Injections Administered | ||||||||||||||||||||||||||||||
End point description |
Full Analysis Set included all enrolled subjects who received >=1 administration of study medication. Study eye = treated eye (with Ozurdex), fellow eye=untreated.
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End point type |
Secondary
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End point timeframe |
Up to Month 14
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No statistical analyses for this end point |
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End point title |
AUC for BCVA | ||||||||||||||||||||||
End point description |
BCVA was measured using an eye chart and is reported as the number of letters read correctly using the early treatment diabetic retinopathy study (ETDRS) Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). ‘n' indicates number of subjects with data available for analysis for the below categories. Full Analysis Set includes all enrolled subjects who received >=1 administration of study medication. Study eye = treated eye (with Ozurdex), fellow eye=untreated.
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End point type |
Secondary
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End point timeframe |
Baseline up to Month 14
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No statistical analyses for this end point |
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End point title |
Mean Change in the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) | ||||||||||||
End point description |
NEI VFQ-25 includes 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items were scored so that a high score represents better functioning. Original numeric values from the survey were recorded with the worst and best possible scores set at 0 and 100 points. In this format, scores represent the achieved percentage of the total possible score, e.g. a score of 50 represents 50% of the highest possible score. ‘n' indicates number of subjects with data available for analysis for the below categories. Full Analysis Set includes all enrolled subjects who received >=1 administration of study medication.
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End point type |
Secondary
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End point timeframe |
Baseline, at Month 14
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No statistical analyses for this end point |
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End point title |
Area Under the Curve (AUC) for CRT | ||||||||||||||||||||||
End point description |
CRT is defined as the central 1000 microns from the center of the fovea and was measured using spectral domain (SD)-OCT. OCT is a laser-based, non-invasive, diagnostic system providing high-resolution imaging optical sections of the retina. ‘n' indicates number of subjects with data available for analysis for the below categories. Full Analysis Set includes all enrolled subjects who received >=1 administration of study medication.
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End point type |
Secondary
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End point timeframe |
Baseline up to Month 14
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No statistical analyses for this end point |
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End point title |
Time to Second Injection | ||||||||
End point description |
Full Analysis Set included all enrolled subjects who received >=1 administration of study medication. Number of subjects analyzed indicates the number of subjects available for analysis.
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End point type |
Secondary
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End point timeframe |
Up to Month 14
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No statistical analyses for this end point |
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End point title |
Time to Third Injection | ||||||||
End point description |
Full Analysis Set included all enrolled subjects who received >=1 administration of study medication. Number of subjects analyzed indicates the number of subjects available for analysis.
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End point type |
Secondary
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End point timeframe |
Up to Month 14
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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 |
From baseline to final visit (up to 14 months)
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Adverse event reporting additional description |
Safety Set consisted of all enrolled patients who received >=1 administration of study medication/procedure.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
22.0
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Reporting groups
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Reporting group title |
OZURDEX
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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? Yes | |||
Date |
Amendment |
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31 May 2019 |
Amendment 03:
- Changes in Efficacy Endpoints.
- Changes on Exclusion Criteria (on regards contraception and WOCBP).
- Change on repeat doses.
- Change on Permitted Medications (Panretinal photocoagulation)
This modification does not affects reference safety information or urgent safety measure, but the scientific value of the trial.
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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 |