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This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of macular edema associated with retinal vein occlusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 700 µg Dexamethasone | Experimental | 700 µg dexamethasone intravitreal implant administered on Day 0 and Day 180. |
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| 350 µg Dexamethasone followed by 700 µg Dexamethasone | Experimental | 350 µg dexamethasone intravitreal implant administered on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180. |
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| Sham Injection followed by 700 µg Dexamethasone | Sham Comparator | Sham injection on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 700 µg Dexamethasone | Drug | 700 µg dexamethasone intravitreal implant administered on Day 0 and/or Day 180. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Response Rate of 15 or More Letter Improvement | The cumulative response rate of 15 or more letter improvement was based on the Kaplan-Meier estimate. A Kaplan-Meier analysis takes into account patients who dropped out from the study prior to achieving the 15 letter improvement. Values ranged from 0-1, with a higher number indicating a higher probability of response. | Up to 180 Days |
| 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 at each visit are presented. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles | California | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20417567 | Background | Haller JA, Bandello F, Belfort R Jr, Blumenkranz MS, Gillies M, Heier J, Loewenstein A, Yoon YH, Jacques ML, Jiao J, Li XY, Whitcup SM; OZURDEX GENEVA Study Group. Randomized, sham-controlled trial of dexamethasone intravitreal implant in patients with macular edema due to retinal vein occlusion. Ophthalmology. 2010 Jun;117(6):1134-1146.e3. doi: 10.1016/j.ophtha.2010.03.032. Epub 2010 Apr 24. |
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Patients were randomly assigned during the double-blind period of the study to treatment with 700 µg dexamethasone, 350 µg dexamethasone, or sham injection on Day 0. Patients who qualified to continue in the open-label period of the study received 700 µg dexamethasone on Day 180.
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| ID | Title | Description |
|---|---|---|
| FG000 | 700 µg Dexamethasone | 700 µg dexamethasone intravitreal implant administered on Day 0 and Day 180. |
| FG001 | 350 µg Dexamethasone Followed by 700 µg Dexamethasone | 350 µg dexamethasone intravitreal implant administered on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Double-Blind Period |
|
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| 350 µg Dexamethasone | Drug | 350 µg Dexamethasone intravitreal implant administered on Day 0. |
|
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| Sham Injection | Other | Sham injection on Day 0. |
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| Day 90, Day 180 |
| Change From Baseline in Retinal Thickness in the Study Eye | Retinal thickness is assessed by optical coherence tomography (OCT) in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement. | Baseline, Day 90, Day 180 |
| Percentage of Patients With a Change From Baseline in BCVA by Category | 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. Data are grouped into the following 5 categories based on change from baseline: ≥15 Letters Improvement, ≥5 and <15 Letters Improvement, No Change (Between -5 to +5 Letters), ≥5 and <15 Letters Worsening, and ≥15 Letters Worsening. | Baseline, Day 90 |
| Percentage of Patients With a Change From Baseline in BCVA by Category | 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. Data are grouped into the following 5 categories based on change from baseline: ≥15 Letters Improvement, ≥5 and <15 Letters Improvement, No Change (Between -5 to +5 Letters), ≥5 and <15 Letters Worsening, and ≥15 Letters Worsening. | Baseline, Day 180 |
| Sydney |
| Australia |
| Graz | Austria |
| Halifax | Nova Scotia | Canada |
| Brno | Czechia |
| Créteil | France |
| Karlsruhe | Germany |
| Rehovot | Israel |
| Tabacalera | Mexico |
| Makati | Philippines |
| Coimbra | Portugal |
| Arcadia | South Africa |
| Kaohsiung City | Taiwan |
| FG002 | Sham Injection Followed by 700 µg Dexamethasone | Sham injection on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180. |
| COMPLETED |
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| NOT COMPLETED |
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| Open-Label Period |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 700 µg Dexamethasone | 700 µg dexamethasone intravitreal implant administered on Day 0 and Day 180. |
| BG001 | 350 µg Dexamethasone Followed by 700 µg Dexamethasone | 350 µg dexamethasone intravitreal implant administered on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180. |
| BG002 | Sham Injection Followed by 700 µg Dexamethasone | Sham injection on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180. |
| BG003 | Total | Total of all reporting groups |
| 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, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | 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 | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | 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 at each visit are presented. | Intent-to-Treat: all randomized patients | Posted | Number | Number of Participants | Day 90, Day 180 |
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| Secondary | Change From Baseline in Retinal Thickness in the Study Eye | Retinal thickness is assessed by optical coherence tomography (OCT) in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement. | Intent-to-Treat: all randomized patients | Posted | Mean | Standard Deviation | Microns (µm) | Baseline, Day 90, Day 180 |
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| Primary | Cumulative Response Rate of 15 or More Letter Improvement | The cumulative response rate of 15 or more letter improvement was based on the Kaplan-Meier estimate. A Kaplan-Meier analysis takes into account patients who dropped out from the study prior to achieving the 15 letter improvement. Values ranged from 0-1, with a higher number indicating a higher probability of response. | Intent-to-Treat: all randomized patients | Posted | Number | Kaplan-Meier Estimate | Up to 180 Days |
|
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| Secondary | Percentage of Patients With a Change From Baseline in BCVA by Category | 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. Data are grouped into the following 5 categories based on change from baseline: ≥15 Letters Improvement, ≥5 and <15 Letters Improvement, No Change (Between -5 to +5 Letters), ≥5 and <15 Letters Worsening, and ≥15 Letters Worsening. | Intent-to-Treat: all randomized patients | Posted | Number | Percentage of Patients | Baseline, Day 90 |
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| Secondary | Percentage of Patients With a Change From Baseline in BCVA by Category | 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. Data are grouped into the following 5 categories based on change from baseline: ≥15 Letters Improvement, ≥5 and <15 Letters Improvement, No Change (Between -5 to +5 Letters), ≥5 and <15 Letters Worsening, and ≥15 Letters Worsening. | Intent-to-Treat: all randomized patients | Posted | Number | Percentage of Patients | Baseline, Day 180 |
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Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.
The safety population included all randomized patients who received at least one dose of study medication and was used to assess AEs and SAEs.
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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 implant administered on Day 0 and Day 180. | 12 | 196 | 119 | 196 | ||
| EG001 | 350 µg Dexamethasone | 350 µg Dexamethasone intravitreal implant administered on Day 0. | 28 | 197 | 107 | 197 | ||
| EG002 | Sham Injection | Sham injection on Day 0. | 14 | 202 | 63 | 202 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA version 11.0 | Non-systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA version 11.0 | Systematic Assessment |
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| Intraocular pressure increased | Investigations | MedDRA version 11.0 | Systematic Assessment |
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| Transient ischaemic attack | Nervous system disorders | MedDRA version 11.0 | Systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA version 11.0 | Systematic Assessment |
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| Carotid artery stenosis | Nervous system disorders | MedDRA version 11.0 | Systematic Assessment |
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| Mental status changes | Psychiatric disorders | MedDRA version 11.0 | Systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | MedDRA version 11.0 | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA version 11.0 | Systematic Assessment |
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| Small intestinal obstruction | Gastrointestinal disorders | MedDRA version 11.0 | Systematic Assessment |
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| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 11.0 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA version 11.0 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA version 11.0 | Non-systematic Assessment |
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| Glaucoma | Eye disorders | MedDRA version 11.0 | Systematic Assessment |
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| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA version 11.0 | Systematic Assessment |
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| Blindness | Eye disorders | MedDRA version 11.0 | Non-systematic Assessment |
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| Cardiogenic shock | Cardiac disorders | MedDRA version 11.0 | Systematic Assessment |
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| Convulsion | Nervous system disorders | MedDRA version 11.0 | Non-systematic Assessment |
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| Drowning | General disorders | MedDRA version 11.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA version 11.0 | Non-systematic Assessment |
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| Humerus fracture | Injury, poisoning and procedural complications | MedDRA version 11.0 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA version 11.0 | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA version 11.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA version 11.0 | Systematic Assessment |
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| Pneumonia viral | Infections and infestations | MedDRA version 11.0 | Systematic Assessment |
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| Renal colic | Renal and urinary disorders | MedDRA version 11.0 | Systematic Assessment |
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| Renal failure acute | Renal and urinary disorders | MedDRA version 11.0 | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA version 11.0 | Systematic Assessment |
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| Retinal vein occlusion | Eye disorders | MedDRA version 11.0 | Systematic Assessment |
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| Blood pressure increased | Investigations | MedDRA version 11.0 | Systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA version 11.0 | Systematic Assessment |
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| Chest pain | General disorders | MedDRA version 11.0 | Non-systematic Assessment |
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| Coronary artery stenosis | Cardiac disorders | MedDRA version 11.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 11.0 | Non-systematic Assessment |
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| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 11.0 | Systematic Assessment |
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| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 11.0 | Systematic Assessment |
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| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA version 11.0 | Systematic Assessment |
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| Thrombotic stroke | Nervous system disorders | MedDRA version 11.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA version 11.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival haemorrhage | Eye disorders | MedDRA version 11.0 | Systematic Assessment |
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| Eye pain | Eye disorders | MedDRA version 11.0 | Non-systematic Assessment |
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| Maculopathy | Eye disorders | MedDRA version 11.0 | Systematic Assessment |
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| Conjunctival hyperaemia | Eye disorders | MedDRA version 11.0 | Systematic Assessment |
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| Intraocular pressure increased | Investigations | MedDRA version 11.0 | 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, Inc. | (714)246-4500 | clinicaltrials@allergan.com |
| ID | Term |
|---|---|
| D008269 | Macular Edema |
| D012170 | Retinal Vein Occlusion |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| C005703 | salicylhydroxamic acid |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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| 45-65 years |
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| >65 years |
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| Male |
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| Title | Measurements |
|---|---|
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