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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 |
|---|---|---|
| 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. | Day 180 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Houston | Texas | 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. |
|
| 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 |
| São Paulo |
| Brazil |
| Mississauga | Ontario | Canada |
| Bogotá | Colombia |
| Kowloon | Hong Kong |
| Tamil Nadu | India |
| Udine | Italy |
| Auckland | New Zealand |
| Poznan | Poland |
| Singapore | Singapore |
| Seoul | South Korea |
| Alicante | Spain |
| London | United Kingdom |
| 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 | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Intent-to-Treat: all randomized patients | Posted | Number | Number of Participants | 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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| 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. | 16 | 225 | 168 | 225 | ||
| EG001 | 350 µg Dexamethasone | 350 µg Dexamethasone intravitreal implant administered on Day 0. | 7 | 215 | 145 | 215 | ||
| EG002 | Sham Injection | Sham injection on Day 0. | 17 | 221 | 94 | 221 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 11.0 | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | 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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| Renal failure acute | Renal and urinary disorders | MedDRA version 11.0 | Systematic Assessment |
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| Aneurysmal bone cyst | Musculoskeletal and connective tissue disorders | MedDRA version 11.0 | Systematic Assessment |
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| Aortic aneurysm | Vascular disorders | MedDRA version 11.0 | Systematic Assessment |
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| Cardiac arrest | Cardiac disorders | MedDRA version 11.0 | Systematic Assessment |
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| Carotid artery occlusion | Nervous system disorders | MedDRA version 11.0 | Systematic Assessment |
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| Cerebellar infarction | Nervous system disorders | MedDRA version 11.0 | Systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | MedDRA version 11.0 | Systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA version 11.0 | Systematic Assessment |
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| Intraocular pressure increased | Investigations | MedDRA version 11.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA version 11.0 | Systematic Assessment |
| |
| Ocular hypertension | Eye 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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| Upper gastrointestinal haemorrhage | Gastrointestinal 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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| Angina pectoris | Cardiac disorders | MedDRA version 11.0 | Non-systematic Assessment |
| |
| Atrial septal defect | Congenital, familial and genetic disorders | MedDRA version 11.0 | Systematic Assessment |
| |
| Chronic lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 11.0 | Systematic Assessment |
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| Parkinson's disease | Nervous system disorders | MedDRA version 11.0 | Systematic Assessment |
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| Angina unstable | Cardiac disorders | MedDRA version 11.0 | Non-systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA version 11.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 11.0 | Non-systematic Assessment |
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| Cellulitis | Infections and infestations | 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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| Cholelithiasis | Hepatobiliary disorders | MedDRA version 11.0 | Systematic Assessment |
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| Foot fracture | Injury, poisoning and procedural complications | MedDRA version 11.0 | Systematic Assessment |
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| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA version 11.0 | Systematic Assessment |
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| Intervertebral disc degeneration | 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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| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 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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| Subarachnoid haemorrhage | 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 |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival haemorrhage | 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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| 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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| Retinal exudates | 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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| Hypertension | Vascular disorders | 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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| Units |
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