Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will use retrospective data to evaluate the efficacy, safety, and re-injection interval of OZURDEX® in the treatment of macular oedema due to Retinal Vein Occlusion (RVO).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All participants | Patients who received at least two OZURDEX® (dexamethasone intravitreal implant) injections. |
|
| 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 |
|---|---|---|
| Time to OZURDEX® Re-injection | Time to OZURDEX® re-injection is the time in days between the first and second OZURDEX® injections. | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Best Corrected Visual Acuity (BCVA) 7 to 12 Weeks Following the Last Injection | BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of letters ranging from 0 (worse) to 100 (best). The change in BCVA was calculated using the most improved number of letters read correctly between 7 and 12 weeks following the last injection of OZURDEX® - the number of letters read correctly at baseline. A positive change from baseline indicates improvement. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients who received at least 2 injections of OZURDEX® to treat macular oedema due to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) in at least 1 eye.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Münster | Germany |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | Patients who received at least two OZURDEX® (dexamethasone intravitreal implant) injections. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Baseline, 7 to 12 weeks following the last injection |
| Percentage of Patients 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 (worse) to 20 (best). An increase of 2 or more lines read correctly compared to baseline is an improvement. | Baseline, Up to 12 months |
| Percentage of Patients 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 (worse) to 20 (best). An increase of 3 or more lines read correctly compared to baseline is an improvement. | Baseline, Up to 12 months |
| Change From Baseline in Central Retinal Thickness by Optical Coherence Tomography (OCT) 7 to 12 Weeks Following the Last 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 7 to 12 weeks after the last injection. A negative change from baseline indicates improvement. | Baseline, 7 to 12 weeks following the last injection |
| Time to Improvement of 2 Lines or More in BCVA | Time to improvement of 2 lines or more in BCVA is defined as the number of days after the first injection of OZURDEX® to achieve an improvement of 2 or more lines read correctly compared to baseline. BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worse) to 20 (best). | Baseline, Up to 12 months |
| Time to Improvement of 3 Lines or More in BCVA | Time to improvement of 3 lines or more in BCVA is defined as the number of days after the first injection of OZURDEX® to achieve an improvement of 3 or more lines read correctly compared to baseline. BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worse) to 20 (best). | Baseline, Up to 12 months |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Patients who received at least two OZURDEX® (dexamethasone intravitreal implant) injections. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Age Mean and Standard Deviation is based on data available for 83 patients. Age data is missing for 4 patients. | Mean | Standard Deviation | Years |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Time to OZURDEX® Re-injection | Time to OZURDEX® re-injection is the time in days between the first and second OZURDEX® injections. | All participants with data available for analysis. | Posted | Mean | Standard Deviation | Days | Up to 12 months |
|
|
| |||||||||||||||||||||||||
| Secondary | Change From Baseline in Best Corrected Visual Acuity (BCVA) 7 to 12 Weeks Following the Last Injection | BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of letters ranging from 0 (worse) to 100 (best). The change in BCVA was calculated using the most improved number of letters read correctly between 7 and 12 weeks following the last injection of OZURDEX® - the number of letters read correctly at baseline. A positive change from baseline indicates improvement. | All participants with data available for analysis. | Posted | Mean | Standard Deviation | Letters | Baseline, 7 to 12 weeks following the last injection |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Patients 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 (worse) to 20 (best). An increase of 2 or more lines read correctly compared to baseline is an improvement. | All treated participants. | Posted | Number | Percentage of participants | Baseline, Up to 12 months |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Patients 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 (worse) to 20 (best). An increase of 3 or more lines read correctly compared to baseline is an improvement. | All treated participants. | Posted | Number | Percentage of participants | Baseline, Up to 12 months |
|
| |||||||||||||||||||||||||||
| Secondary | Change From Baseline in Central Retinal Thickness by Optical Coherence Tomography (OCT) 7 to 12 Weeks Following the Last 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 7 to 12 weeks after the last injection. A negative change from baseline indicates improvement. | All participants with data available for analysis. | Posted | Mean | Standard Deviation | µm | Baseline, 7 to 12 weeks following the last injection |
|
| ||||||||||||||||||||||||||
| Secondary | Time to Improvement of 2 Lines or More in BCVA | Time to improvement of 2 lines or more in BCVA is defined as the number of days after the first injection of OZURDEX® to achieve an improvement of 2 or more lines read correctly compared to baseline. BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worse) to 20 (best). | All participants with data available for analysis. | Posted | Median | Full Range | Days | Baseline, Up to 12 months |
|
| ||||||||||||||||||||||||||
| Secondary | Time to Improvement of 3 Lines or More in BCVA | Time to improvement of 3 lines or more in BCVA is defined as the number of days after the first injection of OZURDEX® to achieve an improvement of 3 or more lines read correctly compared to baseline. BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worse) to 20 (best). | All participants with data available for analysis. | Posted | Median | Full Range | Days | Baseline, Up to 12 months |
|
|
Not provided
This was a retrospective study. Patient charts were reviewed for adverse events (AEs). All AEs related to study drug were collected from the time of the first OZURDEX® injection through six months after the last injection.
Not provided
| 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 two OZURDEX® (dexamethasone intravitreal implant) injections. | 6 | 87 | 47 | 87 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cataract operation | Eye disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Suspected glaucoma | Eye disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Choroidal detachment | Eye disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Cataract progression | Eye disorders | MedDRA 14.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intraocular pressure increased | Investigations | MedDRA 14.1 | Systematic Assessment |
| |
| Glaucoma | Eye disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Eye laser surgery | Eye disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Cataract operation | Eye disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Retinal degeneration | Eye disorders | MedDRA 14.1 | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President Medical Affairs, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
| ID | Term |
|---|---|
| D008269 | Macular Edema |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
| 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 |
Not provided
Not provided
|
|
|
|
|
|