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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OZURDEX® | Participants with diabetic macular edema prescribed dexamethasone intravitreal implant, 0.7 mg (OZURDEX®) as per routine clinical practice. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone intravitreal implant | Drug | Dexamethasone intravitreal implant 0.7 mg injection, as per routine clinical practice. |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean Number of OZURDEX® Implant Reinjections in the Study Eye | Study eye was defined as the eye that received the most OZURDEX® injections. | Up to 44 months |
| 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. | Up to 44 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
- Participant received Ozurdex® implants as part or during a clinical study
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From a public health and market access perspective, the present study population constitutes a broader real-world participant population than that reflected in clinical trials. The present study design does not make any conclusions on causal relationships, but can rather explore real-world Ozurdex® drug utilization patterns, effectiveness and safety. It is expected that the results from this study may be generalizable to the overall population presenting with DME and treated with Ozurdex® in Germany and Switzerland. Participants may contribute at most one eye into the study. If both eyes meet the inclusion criteria, the eye that received the most Ozurdex® injections will be chosen as the study eye.
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| Name | Affiliation | Role |
|---|---|---|
| Paramjit Singh | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trials Registry Team | Irvine | California | 92622 | United States |
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| Label | URL |
|---|---|
| Additional information on study locations near you may be found at AllerganClinicalTrials.com. For any study not on AllerganClinicalTrials.com, please contact IR-CTRegistration@Allergan.com for assistance. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | OZURDEX® | Participants with diabetic macular edema prescribed dexamethasone intravitreal implant, 0.7 mg (OZURDEX®) as per routine clinical practice. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 24, 2019 | Jun 4, 2020 |
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| Last assessment prior to each OZURDEX® injection, 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 | 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. | Baseline (Last assessment prior to the first OZURDEX® injection), 7 to 12 weeks following each injection |
| 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. | Last assessment prior to each OZURDEX® injection, 7 to 12 weeks following each injection |
| 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. | Baseline (Last assessment prior to the first OZURDEX® injection), 7 to 12 weeks following each injection |
| 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. | Up to 44 months |
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| NOT COMPLETED |
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Analysis Population included all selected participants for whom an electronic case report form (eCRF) has been completed and who met selection criteria.
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| ID | Title | Description |
|---|---|---|
| BG000 | OZURDEX® | Participants with diabetic macular edema prescribed dexamethasone intravitreal implant, 0.7 mg (OZURDEX®) as per routine clinical practice. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Number of OZURDEX® Implant Reinjections in the Study Eye | Study eye was defined as the eye that received the most OZURDEX® injections. | Analysis Population included all selected participants for whom an eCRF has been completed and who met selection criteria. | Posted | Mean | Standard Deviation | number of injections | Up to 44 months |
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| 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. | Analysis Population included all selected participants for whom an eCRF has been completed and who met selection criteria. | Posted | Mean | Standard Deviation | months | Up to 44 months |
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| 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. | 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. | Posted | Mean | Standard Deviation | letters | Last assessment prior to each OZURDEX® injection, 7 to 12 weeks following each injection |
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| 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. | 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. | Posted | Mean | Standard Deviation | letters | Baseline (Last assessment prior to the first OZURDEX® injection), 7 to 12 weeks following each injection |
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| 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. | 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. | Posted | Mean | Standard Deviation | micrometer (μm) | Last assessment prior to each OZURDEX® injection, 7 to 12 weeks following each injection |
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| 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. | 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. | Posted | Mean | Standard Deviation | μm | Baseline (Last assessment prior to the first OZURDEX® injection), 7 to 12 weeks following each injection |
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| 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. | Analysis Population included all selected participants for whom an eCRF has been completed and who met selection criteria. | Posted | Number | percentage of participants | Up to 44 months |
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Up to 44 months
Only adverse events of special interest were collected during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | OZURDEX® | Participants with diabetic macular edema prescribed dexamethasone intravitreal implant, 0.7 mg (OZURDEX®) as per routine clinical practice. | 0 | 141 | 0 | 141 | 16 | 141 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intraocular hypertension | Eye disorders | MedDRA: 21.1 | Systematic Assessment |
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| Cataract or lens opacities | Eye disorders | MedDRA: 21.1 | Systematic Assessment |
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A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area, Head | Allergan | 714-246-4500 | clinicaltrials@allergan.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Jul 24, 2018 | Jun 4, 2020 | Prot_001.pdf |
| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D002123 | Calcium Dobesilate |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
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