Diabetic Macular Edema
Conditions
Brief summary
A retrospective, non-interventional, observational, multi-center, drug utilization study to be conducted in adult participants with visual impairment due to DME treated with Ozurdex implants in Germany and Switzerland from 1 January 2015 to 1 September 2017.
Interventions
DRUGDexamethasone intravitreal implant
Dexamethasone intravitreal implant 0.7 mg injection, as per routine clinical practice.
Sponsors
Allergan
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant received at least two Ozurdex® implants in the study eye to treat visual impairment due to DME * First Ozurdex® implant injection occurred after 1 January 2015 * Participant was followed-up at the site for at least 12 months after the first Ozurdex® implant in the study eye
Exclusion criteria
\- Participant received Ozurdex® implants as part or during a clinical study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Number of OZURDEX® Implant Reinjections in the Study Eye | Up to 44 months | Study eye was defined as the eye that received the most OZURDEX® injections. |
| Time to OZURDEX® Reinjection | Up to 44 months | The time to reinjection is defined as the time in months from the date of one OZURDEX® injection to the subsequent OZURDEX® injection. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Central Retinal Thickness (CRT) by Optical Coherence Tomography (OCT) From the Last Assessment Prior to Each OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection | Last assessment prior to each OZURDEX® injection, 7 to 12 weeks following each injection | OCT is measured in the study eye (defined as the eye that received the most OZURDEX® injections) prior to and following each injection of OZURDEX®. OCT is a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina to assess retinal thickness. A negative change indicates an improvement. Change data are reported for each injection relative to the assessment immediately prior to the injection to 7 to 12 weeks following that injection. |
| Change in Best Corrected Visual Acuity (BCVA) From the Last Assessment Prior to Each OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection | Last assessment prior to each OZURDEX® injection, 7 to 12 weeks following each injection | BCVA is measured in the study eye (defined as the eye that received the most OZURDEX® injections) following each injection of OZURDEX® using a special eye chart and is reported as number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision. The higher the number of letters read correctly, the better the vision. A positive number indicates improvement. Change data are reported for each injection relative to the assessment immediately prior to the injection to 7 to 12 weeks following that injection. |
| Percentage of Participants Who Experienced At Least One Adverse Events of Special Interest (AESIs) | Up to 44 months | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a drug whether or not it is considered related to the drug. The adverse events of special interest include: Glaucoma, defined as damage to the optic nerve with progressive vision loss, Intraocular hypertension, defined as intra-ocular pressure (IOP) without meeting the criteria for glaucoma, Hypotony, defined as low IOP ≤5 mmHg, Cataract or lens opacities, Ocular bleeding or hemorrhage, Retinal detachment, tear or hole, Vitreous detachment, Infection vs. Non-infection related Ocular inflammation, Significant vitreous loss, Mechanical failure of device and implant misplacement, Implant dislocation. |
| Change From Baseline in CRT by OCT From the Last Assessment Prior to the First OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection | Baseline (Last assessment prior to the first OZURDEX® injection), 7 to 12 weeks following each injection | OCT is measured at Baseline and following each injection of OZURDEX® in the study eye (defined as the eye that received the most OZURDEX® injections . OCT is a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina to assess retinal thickness. A negative change indicates an improvement. Change data are reported for each injection relative to the assessment prior the first injection to 7 to 12 weeks following each injection. |
| Change From Baseline in BCVA From the Last Assessment Prior to the First OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection | Baseline (Last assessment prior to the first OZURDEX® injection), 7 to 12 weeks following each injection | BCVA is measured in the study eye (defined as the eye that received the most OZURDEX® injections) following each injection of OZURDEX® using a special eye chart and is reported as number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision. The higher the number of letters read correctly, the better the vision. A positive change from baseline indicates improvement. Change data are reported for each injection relative to the assessment prior the first injection to 7 to 12 weeks following each injection. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| OZURDEX® Participants with diabetic macular edema prescribed dexamethasone intravitreal implant, 0.7 mg (OZURDEX®) as per routine clinical practice. | 141 |
| Total | 141 |
Baseline characteristics
| Characteristic | OZURDEX® | — |
|---|---|---|
| Age, Continuous | 65.7 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 57 Participants | — |
| Sex: Female, Male Male | 84 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 141 |
| other Total, other adverse events | 16 / 141 |
| serious Total, serious adverse events | 0 / 141 |
Outcome results
Primary
Mean Number of OZURDEX® Implant Reinjections in the Study Eye
Study eye was defined as the eye that received the most OZURDEX® injections.
Time frame: Up to 44 months
Population: Analysis Population included all selected participants for whom an eCRF has been completed and who met selection criteria.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OZURDEX® | Mean Number of OZURDEX® Implant Reinjections in the Study Eye | 3.0 number of injections | Standard Deviation 1.9 |
Primary
Time to OZURDEX® Reinjection
The time to reinjection is defined as the time in months from the date of one OZURDEX® injection to the subsequent OZURDEX® injection.
Time frame: Up to 44 months
Population: Analysis Population included all selected participants for whom an eCRF has been completed and who met selection criteria.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OZURDEX® | Time to OZURDEX® Reinjection | 5.7 months | Standard Deviation 4.2 |
Secondary
Change From Baseline in BCVA From the Last Assessment Prior to the First OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection
BCVA is measured in the study eye (defined as the eye that received the most OZURDEX® injections) following each injection of OZURDEX® using a special eye chart and is reported as number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision. The higher the number of letters read correctly, the better the vision. A positive change from baseline indicates improvement. Change data are reported for each injection relative to the assessment prior the first injection to 7 to 12 weeks following each injection.
Time frame: Baseline (Last assessment prior to the first OZURDEX® injection), 7 to 12 weeks following each injection
Population: Analysis Population included all selected participants for whom an eCRF has been completed and who met selection criteria. Number analyzed is the number of participants with evaluable data at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OZURDEX® | Change From Baseline in BCVA From the Last Assessment Prior to the First OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection | Baseline to 7-12 weeks After Injection 1 | 3.4 letters | Standard Deviation 13.7 |
| OZURDEX® | Change From Baseline in BCVA From the Last Assessment Prior to the First OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection | Baseline to 7-12 weeks After Reinjection 1 | 3.7 letters | Standard Deviation 10 |
| OZURDEX® | Change From Baseline in BCVA From the Last Assessment Prior to the First OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection | Baseline to 7-12 weeks After Reinjection 2 | 3.2 letters | Standard Deviation 10.9 |
| OZURDEX® | Change From Baseline in BCVA From the Last Assessment Prior to the First OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection | Baseline to 7-12 weeks After Reinjection 3 | -1.4 letters | Standard Deviation 12.5 |
| OZURDEX® | Change From Baseline in BCVA From the Last Assessment Prior to the First OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection | Baseline to 7-12 weeks After Reinjection 4 | 0.5 letters | Standard Deviation 18.6 |
| OZURDEX® | Change From Baseline in BCVA From the Last Assessment Prior to the First OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection | Baseline to 7-12 weeks After Reinjection 5 | 3.5 letters | Standard Deviation 15.4 |
| OZURDEX® | Change From Baseline in BCVA From the Last Assessment Prior to the First OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection | Baseline to 7-12 weeks After Reinjection 6 | 5.1 letters | Standard Deviation 8.2 |
| OZURDEX® | Change From Baseline in BCVA From the Last Assessment Prior to the First OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection | Baseline to 7-12 weeks After Reinjection 7 | 0.0 letters | Standard Deviation 0 |
| OZURDEX® | Change From Baseline in BCVA From the Last Assessment Prior to the First OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection | Baseline to 7-12 weeks After Reinjection 8 | -0.8 letters | Standard Deviation 3.8 |
| OZURDEX® | Change From Baseline in BCVA From the Last Assessment Prior to the First OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection | Baseline to 7-12 weeks After Reinjection 9 | -3.7 letters | Standard Deviation 3.2 |
| OZURDEX® | Change From Baseline in BCVA From the Last Assessment Prior to the First OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection | Baseline to 7-12 weeks After Reinjection 10 | -0.3 letters | Standard Deviation 4.5 |
Secondary
Change From Baseline in CRT by OCT From the Last Assessment Prior to the First OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection
OCT is measured at Baseline and following each injection of OZURDEX® in the study eye (defined as the eye that received the most OZURDEX® injections . OCT is a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina to assess retinal thickness. A negative change indicates an improvement. Change data are reported for each injection relative to the assessment prior the first injection to 7 to 12 weeks following each injection.
Time frame: Baseline (Last assessment prior to the first OZURDEX® injection), 7 to 12 weeks following each injection
Population: Analysis Population included all selected participants for whom an eCRF has been completed and who met selection criteria. Number analyzed is the number of participants with evaluable data at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OZURDEX® | Change From Baseline in CRT by OCT From the Last Assessment Prior to the First OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection | Baseline to 7-12 weeks After Reinjection 2 | -102.4 μm | Standard Deviation 117.6 |
| OZURDEX® | Change From Baseline in CRT by OCT From the Last Assessment Prior to the First OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection | Baseline to 7-12 weeks After Injection 1 | -88.3 μm | Standard Deviation 100.2 |
| OZURDEX® | Change From Baseline in CRT by OCT From the Last Assessment Prior to the First OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection | Baseline to 7-12 weeks After Reinjection 1 | -81.6 μm | Standard Deviation 97.5 |
| OZURDEX® | Change From Baseline in CRT by OCT From the Last Assessment Prior to the First OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection | Baseline to 7-12 weeks After Reinjection 3 | -124.1 μm | Standard Deviation 165.1 |
| OZURDEX® | Change From Baseline in CRT by OCT From the Last Assessment Prior to the First OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection | Baseline to 7-12 weeks After Reinjection 4 | -115.7 μm | Standard Deviation 135.6 |
| OZURDEX® | Change From Baseline in CRT by OCT From the Last Assessment Prior to the First OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection | Baseline to 7-12 weeks After Reinjection 5 | -147.7 μm | Standard Deviation 152.6 |
| OZURDEX® | Change From Baseline in CRT by OCT From the Last Assessment Prior to the First OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection | Baseline to 7-12 weeks After Reinjection 6 | -167.3 μm | Standard Deviation 244.4 |
| OZURDEX® | Change From Baseline in CRT by OCT From the Last Assessment Prior to the First OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection | Baseline to 7-12 weeks After Reinjection 7 | -35.3 μm | Standard Deviation 29 |
| OZURDEX® | Change From Baseline in CRT by OCT From the Last Assessment Prior to the First OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection | Baseline to 7-12 weeks After Reinjection 8 | -22.5 μm | Standard Deviation 6.4 |
| OZURDEX® | Change From Baseline in CRT by OCT From the Last Assessment Prior to the First OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection | Baseline to 7-12 weeks After Reinjection 9 | -19.3 μm | Standard Deviation 91.6 |
| OZURDEX® | Change From Baseline in CRT by OCT From the Last Assessment Prior to the First OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection | Baseline to 7-12 weeks After Reinjection 10 | -42.3 μm | Standard Deviation 62.1 |
Secondary
Change in Best Corrected Visual Acuity (BCVA) From the Last Assessment Prior to Each OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection
BCVA is measured in the study eye (defined as the eye that received the most OZURDEX® injections) following each injection of OZURDEX® using a special eye chart and is reported as number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision. The higher the number of letters read correctly, the better the vision. A positive number indicates improvement. Change data are reported for each injection relative to the assessment immediately prior to the injection to 7 to 12 weeks following that injection.
Time frame: Last assessment prior to each OZURDEX® injection, 7 to 12 weeks following each injection
Population: Analysis Population included all selected participants for whom an eCRF has been completed and who met selection criteria. Number analyzed is the number of participants with evaluable data at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OZURDEX® | Change in Best Corrected Visual Acuity (BCVA) From the Last Assessment Prior to Each OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection | Before Injection 1 to 7-12 weeks After Injection 1 | 3.4 letters | Standard Deviation 13.7 |
| OZURDEX® | Change in Best Corrected Visual Acuity (BCVA) From the Last Assessment Prior to Each OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection | Reinjection 1 to 7-12 weeks After Reinjection 1 | 1.2 letters | Standard Deviation 12.4 |
| OZURDEX® | Change in Best Corrected Visual Acuity (BCVA) From the Last Assessment Prior to Each OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection | Reinjection 2 to 7-12 weeks After Reinjection 2 | 0.5 letters | Standard Deviation 5.8 |
| OZURDEX® | Change in Best Corrected Visual Acuity (BCVA) From the Last Assessment Prior to Each OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection | Reinjection 3 to 7-12 weeks After Reinjection 3 | 3.2 letters | Standard Deviation 8 |
| OZURDEX® | Change in Best Corrected Visual Acuity (BCVA) From the Last Assessment Prior to Each OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection | Reinjection 4 to 7-12 weeks After Reinjection 4 | 3.0 letters | Standard Deviation 4.7 |
| OZURDEX® | Change in Best Corrected Visual Acuity (BCVA) From the Last Assessment Prior to Each OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection | Reinjection 5 to 7-12 weeks After Reinjection 5 | 0.1 letters | Standard Deviation 4.7 |
| OZURDEX® | Change in Best Corrected Visual Acuity (BCVA) From the Last Assessment Prior to Each OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection | Reinjection 6 to 7-12 weeks After Reinjection 6 | -0.3 letters | Standard Deviation 0.6 |
| OZURDEX® | Change in Best Corrected Visual Acuity (BCVA) From the Last Assessment Prior to Each OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection | Reinjection 7 to 7-12 weeks After Reinjection 7 | 0.0 letters | — |
| OZURDEX® | Change in Best Corrected Visual Acuity (BCVA) From the Last Assessment Prior to Each OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection | Reinjection 8 to 7-12 weeks After Reinjection 8 | 6.3 letters | Standard Deviation 8.8 |
| OZURDEX® | Change in Best Corrected Visual Acuity (BCVA) From the Last Assessment Prior to Each OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection | Reinjection 9 to 7-12 weeks After Reinjection 9 | -0.5 letters | Standard Deviation 0.7 |
| OZURDEX® | Change in Best Corrected Visual Acuity (BCVA) From the Last Assessment Prior to Each OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection | Reinjection 10 to 7-12 weeks After Reinjection 10 | 0.0 letters | Standard Deviation 0 |
Secondary
Change in Central Retinal Thickness (CRT) by Optical Coherence Tomography (OCT) From the Last Assessment Prior to Each OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection
OCT is measured in the study eye (defined as the eye that received the most OZURDEX® injections) prior to and following each injection of OZURDEX®. OCT is a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina to assess retinal thickness. A negative change indicates an improvement. Change data are reported for each injection relative to the assessment immediately prior to the injection to 7 to 12 weeks following that injection.
Time frame: Last assessment prior to each OZURDEX® injection, 7 to 12 weeks following each injection
Population: Analysis Population included all selected participants for whom an eCRF has been completed and who met selection criteria. Number analyzed is the number of participants with evaluable data at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OZURDEX® | Change in Central Retinal Thickness (CRT) by Optical Coherence Tomography (OCT) From the Last Assessment Prior to Each OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection | Before Injection 1 to 7-12 weeks After Injection 1 | -88.3 micrometer (μm) | Standard Deviation 100.2 |
| OZURDEX® | Change in Central Retinal Thickness (CRT) by Optical Coherence Tomography (OCT) From the Last Assessment Prior to Each OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection | Reinjection 1 to 7-12 weeks After Reinjection 1 | -63.9 micrometer (μm) | Standard Deviation 79.6 |
| OZURDEX® | Change in Central Retinal Thickness (CRT) by Optical Coherence Tomography (OCT) From the Last Assessment Prior to Each OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection | Reinjection 2 to 7-12 weeks After Reinjection 2 | -70.4 micrometer (μm) | Standard Deviation 96.4 |
| OZURDEX® | Change in Central Retinal Thickness (CRT) by Optical Coherence Tomography (OCT) From the Last Assessment Prior to Each OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection | Reinjection 3 to 7-12 weeks After Reinjection 3 | -51.6 micrometer (μm) | Standard Deviation 54.4 |
| OZURDEX® | Change in Central Retinal Thickness (CRT) by Optical Coherence Tomography (OCT) From the Last Assessment Prior to Each OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection | Reinjection 4 to 7-12 weeks After Reinjection 4 | -84.0 micrometer (μm) | Standard Deviation 94.4 |
| OZURDEX® | Change in Central Retinal Thickness (CRT) by Optical Coherence Tomography (OCT) From the Last Assessment Prior to Each OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection | Reinjection 5 to 7-12 weeks After Reinjection 5 | -60.6 micrometer (μm) | Standard Deviation 44.2 |
| OZURDEX® | Change in Central Retinal Thickness (CRT) by Optical Coherence Tomography (OCT) From the Last Assessment Prior to Each OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection | Reinjection 6 to 7-12 weeks After Reinjection 6 | -68.3 micrometer (μm) | Standard Deviation 93.9 |
| OZURDEX® | Change in Central Retinal Thickness (CRT) by Optical Coherence Tomography (OCT) From the Last Assessment Prior to Each OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection | Reinjection 7 to 7-12 weeks After Reinjection 7 | -3.0 micrometer (μm) | — |
| OZURDEX® | Change in Central Retinal Thickness (CRT) by Optical Coherence Tomography (OCT) From the Last Assessment Prior to Each OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection | Reinjection 8 to 7-12 weeks After Reinjection 8 | -70.0 micrometer (μm) | — |
| OZURDEX® | Change in Central Retinal Thickness (CRT) by Optical Coherence Tomography (OCT) From the Last Assessment Prior to Each OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection | Reinjection 9 to 7-12 weeks After Reinjection 9 | -55.5 micrometer (μm) | Standard Deviation 4.9 |
| OZURDEX® | Change in Central Retinal Thickness (CRT) by Optical Coherence Tomography (OCT) From the Last Assessment Prior to Each OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection | Reinjection 10 to 7-12 weeks After Reinjection 10 | -15.0 micrometer (μm) | Standard Deviation 2.8 |
Secondary
Percentage of Participants Who Experienced At Least One Adverse Events of Special Interest (AESIs)
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a drug whether or not it is considered related to the drug. The adverse events of special interest include: Glaucoma, defined as damage to the optic nerve with progressive vision loss, Intraocular hypertension, defined as intra-ocular pressure (IOP) without meeting the criteria for glaucoma, Hypotony, defined as low IOP ≤5 mmHg, Cataract or lens opacities, Ocular bleeding or hemorrhage, Retinal detachment, tear or hole, Vitreous detachment, Infection vs. Non-infection related Ocular inflammation, Significant vitreous loss, Mechanical failure of device and implant misplacement, Implant dislocation.
Time frame: Up to 44 months
Population: Analysis Population included all selected participants for whom an eCRF has been completed and who met selection criteria.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| OZURDEX® | Percentage of Participants Who Experienced At Least One Adverse Events of Special Interest (AESIs) | 18.4 percentage of participants |