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This study will evaluate the safety and efficacy of the intravitreal implant of dexamethasone with laser treatment vs. laser treatment alone in patients with diabetic macular edema.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 700 µg Dexamethasone Implant and Laser Photocoagulation | Experimental | Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria. |
|
| Sham Implant and Laser Photocoagulation | Sham Comparator | Initial sham injection with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With at Least 10 Letters of Improvement in Best Corrected Visual Acuity (BCVA) From Baseline in the Study Eye | BCVA is measured in the study eye 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 indicates improvement and a decrease in the number of letters read correctly indicates a worsening. | Baseline, Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in BCVA in the Study Eye | BCVA is measured in the study eye 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 indicates improvement and a decrease in the number of letters read correctly indicates a worsening. |
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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 |
|---|---|---|---|---|---|---|
| Artesia | California | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23706947 | Background | Callanan DG, Gupta S, Boyer DS, Ciulla TA, Singer MA, Kuppermann BD, Liu CC, Li XY, Hollander DA, Schiffman RM, Whitcup SM; Ozurdex PLACID Study Group. Dexamethasone intravitreal implant in combination with laser photocoagulation for the treatment of diffuse diabetic macular edema. Ophthalmology. 2013 Sep;120(9):1843-51. doi: 10.1016/j.ophtha.2013.02.018. Epub 2013 May 22. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 700 µg Dexamethasone Implant and Laser Photocoagulation | Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria. |
| FG001 | Sham Implant and Laser Photocoagulation | Initial sham injection with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 700 µg Dexamethasone Implant and Laser Photocoagulation | Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria. |
| BG001 | Sham Implant and Laser Photocoagulation |
| 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 | Percentage of Patients With at Least 10 Letters of Improvement in Best Corrected Visual Acuity (BCVA) From Baseline in the Study Eye | BCVA is measured in the study eye 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 indicates improvement and a decrease in the number of letters read correctly indicates a worsening. | Intent to Treat: all randomized patients | Posted | Number | Percentage of Patients | Baseline, Month 12 |
|
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The Safety Population was used to assess all serious adverse events (SAEs) and adverse events (AEs) and included all patients who were randomized and treated.
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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 Implant and Laser Photocoagulation | Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA version 10.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival Haemorrhage | Eye disorders | MedDRA version 10.0 | 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 |
|---|---|
| D003907 | Dexamethasone |
| C005703 | salicylhydroxamic acid |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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|
| Sham injection | Drug | Initial sham injection with up to 1 additional treatment based on re-treatment criteria. |
|
| Laser Photocoagulation | Procedure | Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria. |
|
| Baseline, Month 12 |
| Change From Baseline in Central Subfield Retinal Thickness in the Study Eye | Central subfield retinal thickness is assessed in the study eye by Optical Coherence Tomography (OCT). The central subfield is an area in the retina (back of the eye). OCT is a laser-based, noninvasive, diagnostic system that provides high-resolution, three-dimensional images of the retina from which retinal thickness can be measured. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening. | Baseline, Month 12 |
| Change From Baseline in the Focal Leakage Area in the Study Eye | Focal leakage area in the study eye is assessed using fluorescein angiography. A positive number change from baseline indicates a worsening and a negative number change from baseline indicates an improvement. | Baseline, Month 12 |
| Time to Retreatment in the Study Eye | Time to retreatment in the study eye is defined as the number of days between the initial treatment and re-treatment with the study medication. | 12 Months |
| Victoria |
| British Columbia |
| Canada |
Initial sham injection with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Sham Implant and Laser Photocoagulation | Initial sham injection with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria. |
|
|
| Secondary | Change From Baseline in BCVA in the Study Eye | BCVA is measured in the study eye 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 indicates improvement and a decrease in the number of letters read correctly indicates a worsening. | Intent to Treat: all randomized patients | Posted | Mean | Standard Deviation | Letters Read Correctly | Baseline, Month 12 |
|
|
|
| Secondary | Change From Baseline in Central Subfield Retinal Thickness in the Study Eye | Central subfield retinal thickness is assessed in the study eye by Optical Coherence Tomography (OCT). The central subfield is an area in the retina (back of the eye). OCT is a laser-based, noninvasive, diagnostic system that provides high-resolution, three-dimensional images of the retina from which retinal thickness can be measured. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening. | Intent to Treat: all randomized patients | Posted | Mean | Standard Deviation | Microns | Baseline, Month 12 |
|
|
|
| Secondary | Change From Baseline in the Focal Leakage Area in the Study Eye | Focal leakage area in the study eye is assessed using fluorescein angiography. A positive number change from baseline indicates a worsening and a negative number change from baseline indicates an improvement. | Intent to Treat: all randomized patients | Posted | Mean | Standard Deviation | Millimeters Squared (mm^2) | Baseline, Month 12 |
|
|
|
| Secondary | Time to Retreatment in the Study Eye | Time to retreatment in the study eye is defined as the number of days between the initial treatment and re-treatment with the study medication. | Intent to Treat: all randomized patients | Posted | Median | 95% Confidence Interval | Days | 12 Months |
|
|
|
| 23 |
| 125 |
| 125 |
| 125 |
| EG001 | Sham Implant and Laser Photocoagulation | Initial sham injection with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria. | 27 | 127 | 127 | 127 |
| Coronary Artery Disease | Cardiac disorders | MedDRA version 10.0 | Systematic Assessment |
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| Neuropathic Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA version 10.0 | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA version 10.0 | Non-systematic Assessment |
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| Cardiac Failure Congestive | Cardiac disorders | MedDRA version 10.0 | Systematic Assessment |
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| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA version 10.0 | Systematic Assessment |
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| Cerebrovascular Accident | Nervous system disorders | MedDRA version 10.0 | Systematic Assessment |
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| Intervertebral Disc Degeneration | Musculoskeletal and connective tissue disorders | MedDRA version 10.0 | Systematic Assessment |
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| Lung Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 10.0 | Systematic Assessment |
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| Renal Failure | Renal and urinary disorders | MedDRA version 10.0 | Systematic Assessment |
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| Aortic Stenosis | Vascular disorders | MedDRA version 10.0 | Systematic Assessment |
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| Basal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 10.0 | Systematic Assessment |
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| Chest Pain | General disorders | MedDRA version 10.0 | Non-systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA version 10.0 | Systematic Assessment |
|
| Diabetic Foot Infection | Infections and infestations | MedDRA version 10.0 | Non-systematic Assessment |
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| Dialysis Disequilibrium Syndrome | Injury, poisoning and procedural complications | MedDRA version 10.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA version 10.0 | Non-systematic Assessment |
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| Femur Fracture | Injury, poisoning and procedural complications | MedDRA version 10.0 | Systematic Assessment |
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| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA version 10.0 | Systematic Assessment |
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| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDRA version 10.0 | Non-systematic Assessment |
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| Haemorrhagic Anaemia | Blood and lymphatic system disorders | MedDRA version 10.0 | Systematic Assessment |
|
| Hepatic Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 10.0 | Systematic Assessment |
|
| Hip Fracture | Injury, poisoning and procedural complications | MedDRA version 10.0 | Systematic Assessment |
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| Hypoaesthesia Facial | Skin and subcutaneous tissue disorders | MedDRA version 10.0 | Non-systematic Assessment |
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| Hypoglycaemic Seizure | Metabolism and nutrition disorders | MedDRA version 10.0 | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA version 10.0 | Systematic Assessment |
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| Inguinal Hernia, Obstructive | Gastrointestinal disorders | MedDRA version 10.0 | Systematic Assessment |
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| Joint Dislocation | Injury, poisoning and procedural complications | MedDRA version 10.0 | Non-systematic Assessment |
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| Osteomyelitis | Infections and infestations | MedDRA version 10.0 | Systematic Assessment |
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| Procedural Pain | Injury, poisoning and procedural complications | MedDRA version 10.0 | Non-systematic Assessment |
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| Renal Failure Acute | Renal and urinary disorders | MedDRA version 10.0 | Systematic Assessment |
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| Squamous Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 10.0 | Systematic Assessment |
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| Staphylococcal Infection | Infections and infestations | MedDRA version 10.0 | Systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | MedDRA version 10.0 | Systematic Assessment |
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| Vitreous Haemorrhage | Eye disorders | MedDRA version 10.0 | Systematic Assessment |
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| Gangrene | Infections and infestations | MedDRA version 10.0 | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA version 10.0 | Systematic Assessment |
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| Myocardial Infarction | Cardiac disorders | MedDRA version 10.0 | Systematic Assessment |
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| Transient Ischaemic Attack | Nervous system disorders | MedDRA version 10.0 | Systematic Assessment |
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| Ankle Fracture | Injury, poisoning and procedural complications | MedDRA version 10.0 | Systematic Assessment |
|
| Atrial Fibrillation | Cardiac disorders | MedDRA version 10.0 | Systematic Assessment |
|
| Benign Neoplasm of Thyroid Gland | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 10.0 | Systematic Assessment |
|
| Bladder Neck Obstruction | Renal and urinary disorders | MedDRA version 10.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA version 10.0 | Non-systematic Assessment |
|
| Cardiac Failure | Cardiac disorders | MedDRA version 10.0 | Systematic Assessment |
|
| Cardio-respiratory Arrest | Cardiac disorders | MedDRA version 10.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA version 10.0 | Systematic Assessment |
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| Cervical Spinal Stenosis | Musculoskeletal and connective tissue disorders | MedDRA version 10.0 | Systematic Assessment |
|
| Cholecystitis Acute | Hepatobiliary disorders | MedDRA version 10.0 | Systematic Assessment |
|
| Dementia Alzheimer's Type | Nervous system disorders | MedDRA version 10.0 | Non-systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA version 10.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 10.0 | Non-systematic Assessment |
|
| Failure to Thrive | Metabolism and nutrition disorders | MedDRA version 10.0 | Non-systematic Assessment |
|
| Gastrointestinal Necrosis | Gastrointestinal disorders | MedDRA version 10.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA version 10.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA version 10.0 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA version 10.0 | Systematic Assessment |
|
| Incision Site Infection | Infections and infestations | MedDRA version 10.0 | Non-systematic Assessment |
|
| Obesity | Metabolism and nutrition disorders | MedDRA version 10.0 | Non-systematic Assessment |
|
| Skull Fracture | Injury, poisoning and procedural complications | MedDRA version 10.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA version 10.0 | Non-systematic Assessment |
|
| Vitreous Haemorrhage | Eye disorders | MedDRA version 10.0 | Systematic Assessment |
|
| Visual Acuity Reduced | Eye disorders | MedDRA version 10.0 | Non-systematic Assessment |
|
| Cataract | Eye disorders | MedDRA version 10.0 | Systematic Assessment |
|
| Eye Pain | Eye disorders | MedDRA version 10.0 | Non-systematic Assessment |
|
| Vitreous Floaters | Eye disorders | MedDRA version 10.0 | Non-systematic Assessment |
|
| Macular Oedema | Eye disorders | MedDRA version 10.0 | Systematic Assessment |
|
| Maculopathy | Eye disorders | MedDRA version 10.0 | Systematic Assessment |
|
| Vitreous Detachment | Eye disorders | MedDRA version 10.0 | Systematic Assessment |
|
| Retinal Exudates | Eye disorders | MedDRA version 10.0 | Systematic Assessment |
|
| Diabetic Retinal Oedema | Eye disorders | MedDRA version 10.0 | Systematic Assessment |
|
| Retinal Haemorrhage | Eye disorders | MedDRA version 10.0 | Systematic Assessment |
|
| Vision Blurred | Eye disorders | MedDRA version 10.0 | Non-systematic Assessment |
|
| Oedema Peripheral | General disorders | MedDRA version 10.0 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA version 10.0 | Systematic Assessment |
|
| Upper Respiratory Infection | Infections and infestations | MedDRA version 10.0 | Non-systematic Assessment |
|
| Intraocular Pressure Increased | Investigations | MedDRA version 10.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA version 10.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA version 10.0 | 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 |