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This study will assess the safety and efficacy of 700 μg dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) Applicator System in patients with macular edema in a 6 month double-blind period versus sham followed by a 2 month open label period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 700 μg Dexamethasone | Experimental | 700 μg Dexamethasone intravitreal injection in the study eye on Day 1. |
|
| Sham | Sham Comparator | Sham administered in the study eye on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 700 μg Dexamethasone | Drug | 700 μg Dexamethasone intravitreal injection in the study eye on Day 1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye | BCVA is measured using an eye chart and is reported as the 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 (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The numbers of patients with at least a 15 or more letter improvement in BCVA in the study eye are presented. | Baseline, 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Average Change From Baseline in BCVA in the Study Eye | BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The average BCVA is calculated across study visits for each patient. A positive number change from baseline indicates an improvement and a negative number change from baseline indicates a worsening. |
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Inclusion Criteria:
-Presence of macular edema defined as macular thickening involving the center of the macula due to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29119239 | Background | Li X, Wang N, Liang X, Xu G, Li XY, Jiao J, Lou J, Hashad Y; China Ozurdex in RVO Study Group. Safety and efficacy of dexamethasone intravitreal implant for treatment of macular edema secondary to retinal vein occlusion in Chinese patients: randomized, sham-controlled, multicenter study. Graefes Arch Clin Exp Ophthalmol. 2018 Jan;256(1):59-69. doi: 10.1007/s00417-017-3831-6. Epub 2017 Nov 8. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 700 μg Dexamethasone | 700 μg Dexamethasone intravitreal injection in the study eye on Day 1. |
| FG001 | Sham | Sham administered in the study eye on Day 1. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 700 μg Dexamethasone | 700 μg Dexamethasone intravitreal injection in the study eye on Day 1. |
| BG001 | Sham | Sham administered in the study eye on Day 1. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye | BCVA is measured using an eye chart and is reported as the 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 (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The numbers of patients with at least a 15 or more letter improvement in BCVA in the study eye are presented. | Modified Intent-to-Treat: all randomized and treated patients | Posted | Number | Patients | Baseline, 6 Months |
|
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The Safety Population included all treated patients and was used to assess adverse events (AEs) and serious adverse events (SAEs). Treatment emergent adverse events (TEAE) are reported and include all AEs and SAEs that began or worsened after study treatment.
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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 | 700 μg Dexamethasone | 700 μg Dexamethasone intravitreal injection in the study eye on Day 1. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrioventricular Block | Cardiac disorders | MedDRA version 17.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival Haemorrhage | Eye disorders | MedDRA version 17.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head, | 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 |
| C005703 | salicylhydroxamic acid |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Sham | Other | Sham administered in the study eye on Day 1. |
|
| Baseline, 6 Months |
| Change From Baseline in BCVA in the Study Eye | BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. A decrease in the number of letters read correctly (negative number) means that vision has worsened. | Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6 |
| Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye | BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening. | Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Sham |
Sham administered in the study eye on Day 1. |
|
|
| Secondary | Average Change From Baseline in BCVA in the Study Eye | BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The average BCVA is calculated across study visits for each patient. A positive number change from baseline indicates an improvement and a negative number change from baseline indicates a worsening. | Modified Intent-to-Treat: all randomized and treated patients | Posted | Mean | Standard Deviation | Letters Read Correctly | Baseline, 6 Months |
|
|
|
| Secondary | Change From Baseline in BCVA in the Study Eye | BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. A decrease in the number of letters read correctly (negative number) means that vision has worsened. | Modified Intent-to-Treat: all randomized and treated patients | Posted | Mean | Standard Deviation | Letters Read Correctly | Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6 |
|
|
|
| Secondary | Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye | BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening. | Modified Intent-to-Treat: all randomized and treated patients | Posted | Number | Percentage of Patients | Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6 |
|
|
|
| 1 |
| 129 |
| 69 |
| 129 |
| EG001 | Sham | Sham administered in the study eye on Day 1. | 2 | 130 | 15 | 130 |
| Cholecystitis Chronic | Hepatobiliary disorders | MedDRA version 17.0 | Systematic Assessment |
|
| Vitreous Haemorrhage | Eye disorders | MedDRA version 17.0 | Systematic Assessment |
|
| Conjunctival Hyperaemia | Eye disorders | MedDRA version 17.0 | Systematic Assessment |
|
| Intraocular Pressure Increased | Investigations | MedDRA version 17.0 | 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 at least 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 |
| Change from Baseline at Month 2 |
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| Change from Baseline at Month 4 |
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| Change from Baseline at Month 5 |
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| Change from Baseline at Month 6 |
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| Month 6 |
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