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This retrospective chart review study will describe the history of patients with retinal disease with macular edema to whom OZURDEX® (dexamethasone intravitreal implant) is administered, and assess treatment patterns and visual outcomes. OZURDEX® was previously administered according to general clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Participants | Patients with macular edema previously treated with dexamethasone intravitreal implant (OZURDEX®) according to general clinical practice. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone Intravitreal Implant | Drug | Dexamethasone Intravitreal Implant (OZURDEX®) previously administered according to general clinical practice. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak Mean Change From Baseline in Best Corrected Visual Acuity (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). The peak mean change in BCVA was calculated using the most improved number of lines read correctly between 2 and 26 weeks following the last available injection of OZURDEX® - the number of lines read correctly at Baseline. A positive change from Baseline indicated improvement. | Baseline, 2 to 26 weeks (wks) following last injection (up to 6.5 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Mean Change From Baseline in Central Retinal Thickness (CRT) | 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. The peak mean change was the maximum change from Baseline in CRT at 2 to 26 weeks following the last available injection of OZURDEX®. A negative change from Baseline indicated improvement. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with macular edema
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Québec | Quebec | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26203215 | Background | Lam WC, Albiani DA, Yoganathan P, Chen JC, Kherani A, Maberley DA, Oliver A, Rabinovitch T, Sheidow TG, Tourville E, Wittenberg LA, Sigouin C, Baptiste DC. Real-world assessment of intravitreal dexamethasone implant (0.7 mg) in patients with macular edema: the CHROME study. Clin Ophthalmol. 2015 Jul 10;9:1255-68. doi: 10.2147/OPTH.S80500. eCollection 2015. |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | Patients with macular edema previously treated with dexamethasone intravitreal implant (OZURDEX®) according to general clinical practice. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Patients with macular edema previously treated with dexamethasone intravitreal implant (OZURDEX®) according to general clinical practice. |
| 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 | Peak Mean Change From Baseline in Best Corrected Visual Acuity (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). The peak mean change in BCVA was calculated using the most improved number of lines read correctly between 2 and 26 weeks following the last available injection of OZURDEX® - the number of lines read correctly at Baseline. A positive change from Baseline indicated improvement. | All participants with BCVA observations available following the last OZURDEX® injection from 2 to 26 weeks. | Posted | Mean | Standard Error | Lines | Baseline, 2 to 26 weeks (wks) following last injection (up to 6.5 months) | Eyes | Eyes |
|
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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 with macular edema previously treated with dexamethasone intravitreal implant (OZURDEX®) according to general clinical practice. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Endophthalmitis | Eye disorders | MedDRA 16.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intraocular pressure increased | Investigations | MedDRA 16.0 | 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 |
|---|---|
| D008269 | Macular Edema |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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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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|
| Baseline, 2 to 26 weeks following last injection (up to 6.5 months) |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Peak Mean Change From Baseline in Central Retinal Thickness (CRT) | 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. The peak mean change was the maximum change from Baseline in CRT at 2 to 26 weeks following the last available injection of OZURDEX®. A negative change from Baseline indicated improvement. | All participants with CRT observations available following the last OZURDEX® injection from 2 to 26 weeks. | Posted | Mean | Standard Error | microns (μm) | Baseline, 2 to 26 weeks following last injection (up to 6.5 months) | Eyes | Eyes |
|
|
|
| 4 |
| 101 |
| 25 |
| 101 |
| Uveitis | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Retinal detachment | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Retinal implant | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
|
| Cystoid macular oedema | Eye disorders | MedDRA 16.0 | 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.
| 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 |