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| ID | Type | Description | Link |
|---|---|---|---|
| GMA-320 | Other Identifier | Allergan, Inc. |
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This is a retrospective data collection study to evaluate the efficacy, safety, and re-injection interval of OZURDEX® in the treatment of macular edema due to RVO. Following informed consent, there were no patient study visits. All data was collected via chart review.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Participants | Patients who received at least 2 injections of OZURDEX® (dexamethasone intravitreal implant) to treat Macular Edema. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dexamethasone intravitreal implant 0.7 mg | Drug | Dexamethasone intravitreal implant 0.7 mg was dosed previously according to general clinical practice. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Best Corrected Visual Acuity (BCVA) 4 to 20 Weeks Following the Last OZURDEX® (Dexamethasone Intravitreal Implant) Injection | BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). The change in BCVA was calculated using the most improved number of lines read correctly between 4 and 20 weeks following the last injection of OZURDEX® - the number of lines read correctly at baseline. A positive change from baseline indicates improvement. | Baseline, 4 to 20 weeks after last injection (Up to 6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With an Increase of 2 Lines or More in BCVA | BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). An increase of 2 or more lines read correctly compared to baseline is an improvement. | Baseline, Up to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who received at least 2 injections of OZURDEX® to treat macular edema due to RVO in at least one eye.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Antonio | Texas | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26337664 | Derived | Dugel PU, Capone A Jr, Singer MA, Dreyer RF, Dodwell DG, Roth DB, Shi R, Walt JG, Scott LC, Hollander DA; SHASTA Study Group. Two or more dexamethasone intravitreal implants in treatment-naive patients with macular edema due to retinal vein occlusion: subgroup analysis of a retrospective chart review study. BMC Ophthalmol. 2015 Sep 4;15:118. doi: 10.1186/s12886-015-0106-z. | |
| 25885285 |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | Patients who received at least 2 injections of OZURDEX® (dexamethasone intravitreal implant) to treat Macular Edema. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Patients who received at least 2 injections of OZURDEX® (dexamethasone intravitreal implant) to treat Macular Edema. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 | Change From Baseline in Best Corrected Visual Acuity (BCVA) 4 to 20 Weeks Following the Last OZURDEX® (Dexamethasone Intravitreal Implant) Injection | BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). The change in BCVA was calculated using the most improved number of lines read correctly between 4 and 20 weeks following the last injection of OZURDEX® - the number of lines read correctly at baseline. A positive change from baseline indicates improvement. | All participants with data available for analysis. | Posted | Mean | Full Range | Lines | Baseline, 4 to 20 weeks after last injection (Up to 6 months) |
|
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SAEs (serious adverse events) and AEs (adverse events) were collected retrospectively from chart data.
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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 | All Participants | Patients who received at least 2 injections of OZURDEX® (dexamethasone intravitreal implant) to treat Macular Edema. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cataract | Eye disorders | MedDRA 13.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President Medical Affairs, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
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| ID | Term |
|---|---|
| D012170 | Retinal Vein Occlusion |
| D008269 | Macular Edema |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D002123 | Calcium Dobesilate |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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|
| Percentage of Participants With an Increase of 3 Lines or More in BCVA |
BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). An increase of 3 or more lines read correctly compared to baseline is an improvement. |
| Baseline, Up to 6 months |
| Change From Baseline in Central Retinal Thickness by Optical Coherence Tomography (OCT) 4 to 20 Weeks After Each Injection | Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed in the study eye after pupil dilation at baseline and 4 to 20 weeks after each injection. A negative change from baseline indicates improvement. | Baseline, 4 to 20 Weeks after Each injection (up to 6 months) |
| Derived |
| Singer MA, Capone A Jr, Dugel PU, Dreyer RF, Dodwell DG, Roth DB, Shi R, Walt JG, Scott LC, Hollander DA; SHASTA Study Group. Two or more dexamethasone intravitreal implants as monotherapy or in combination therapy for macular edema in retinal vein occlusion: subgroup analysis of a retrospective chart review study. BMC Ophthalmol. 2015 Apr 1;15:33. doi: 10.1186/s12886-015-0018-y. |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Percentage of Participants With an Increase of 2 Lines or More in BCVA | BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). An increase of 2 or more lines read correctly compared to baseline is an improvement. | All participants. | Posted | Number | Percentage of participants | Baseline, Up to 6 months |
|
|
|
| Secondary | Percentage of Participants With an Increase of 3 Lines or More in BCVA | BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). An increase of 3 or more lines read correctly compared to baseline is an improvement. | All participants. | Posted | Number | Percentage of participants | Baseline, Up to 6 months |
|
|
|
| Secondary | Change From Baseline in Central Retinal Thickness by Optical Coherence Tomography (OCT) 4 to 20 Weeks After Each Injection | Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed in the study eye after pupil dilation at baseline and 4 to 20 weeks after each injection. A negative change from baseline indicates improvement. | All participants with data available for analysis. | Posted | Mean | Standard Deviation | Micron (μm) | Baseline, 4 to 20 Weeks after Each injection (up to 6 months) |
|
|
|
| 7 |
| 289 |
| 49 |
| 289 |
| Atrial fibrillation | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
|
| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Heart rate irregular | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Intraocular pressure increased | Investigations | MedDRA 13.1 | Systematic Assessment |
|
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.
| D016769 |
| Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| 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 |
|
| Change from baseline; third injection (n=128) |
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| Change from baseline; fourth injection (n=67) |
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| Change from baseline; fifth injection (n=31) |
|
| Change from baseline; sixth injection (n=16) |
|
| Change from baseline; seventh injection (n=5) |
|
| Change from baseline; eighth injection (n=1) |
|
| Change from baseline; ninth injection (n=1) |
|