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This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of diabetic macular edema.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexamethasone 700 μg | Experimental | 700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months. |
|
| Dexamethasone 350 μg | Experimental | 350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months. |
|
| Sham | Sham Comparator | Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | 350 µg or 700 µg dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With a Best Corrected Visual Acuity (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 39/Final Visit |
| 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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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 |
|---|---|---|---|---|---|---|
| Artesia | California | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40712145 | Derived | Blinder KJ, Wykoff CC, Ferencz JR, Ehlers JP, Fang Y, Lai H, Ogidigben M, Lopez FJ. IMPACT OF THE DEXAMETHASONE IMPLANT ON SLOWING DIABETIC RETINOPATHY PROGRESSION: Post Hoc Analysis of the MEAD Study. Retina. 2025 Dec 1;45(12):2252-2262. doi: 10.1097/IAE.0000000000004623. | |
| 40688490 | Derived | Kozak I, Do DV, Lai H, Ogidigben MJ, Lopez FJ. Time-in-Range Analysis of Responses after Intravitreal Dexamethasone Therapy in Eyes with Diabetic Macular Edema. Ophthalmol Sci. 2025 May 26;5(5):100833. doi: 10.1016/j.xops.2025.100833. eCollection 2025 Sep-Oct. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dexamethasone 700 μg | 700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months. |
| FG001 | Dexamethasone 350 μg | 350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months. |
| FG002 | Sham | Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dexamethasone 700 μg | 700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months. |
| BG001 | Dexamethasone 350 μg |
| 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 a Best Corrected Visual Acuity (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. | Intent to Treat: all randomized patients | Posted | Number | Percentage of Patients | Baseline, Month 39/Final Visit |
|
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The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
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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 | Dexamethasone 700 μg | 700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA version 15.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cataract | Eye disorders | MedDRA version 15.0 | 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 |
| D002123 | Calcium Dobesilate |
| C005703 | salicylhydroxamic acid |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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|
| Sham | Other | Sham posterior segment drug delivery system-needle-less drug delivery system without study medication not less than every 6 months for up to 36 months. |
|
| Baseline, 39 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). A positive number change from baseline indicates an improvement and a negative number change from baseline indicates a worsening. | Baseline, Month 39/Final Visit |
| Percentage of Patients With a BCVA Improvement of ≥10 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 39/Final Visit |
| Change From Baseline in Retinal Thickness as Measured by Optical Coherence Tomography (OCT) | 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 39/Final Visit |
| São Paulo |
| Brazil |
| Mississauga | Ontario | Canada |
| Bogotá | Colombia |
| Dijon | France |
| Budapest | Hungary |
| New Delhi | India |
| Milan | Italy |
| Auckland | New Zealand |
| Warsaw | Poland |
| Singapore | Singapore |
| Seoul | South Korea |
| Taipei | Taiwan |
| London | United Kingdom |
| 40634898 | Derived | Valentim CCS, Lai H, Ogidigben MJ, Singh RP, Talcott KE. Baseline factors affecting diabetic macular oedema resolution after intravitreal dexamethasone implant treatment: post hoc analysis of the MEAD study. BMC Ophthalmol. 2025 Jul 9;25(1):403. doi: 10.1186/s12886-025-04208-3. |
| 33206392 | Derived | Rittiphairoj T, Mir TA, Li T, Virgili G. Intravitreal steroids for macular edema in diabetes. Cochrane Database Syst Rev. 2020 Nov 17;11(11):CD005656. doi: 10.1002/14651858.CD005656.pub3. |
| 31654188 | Derived | Yoon YH, Boyer DS, Maturi RK, Bandello F, Belfort R Jr, Augustin AJ, Li XY, Bai Z, Hashad Y; Ozurdex MEAD Study Group. Natural history of diabetic macular edema and factors predicting outcomes in sham-treated patients (MEAD study). Graefes Arch Clin Exp Ophthalmol. 2019 Dec;257(12):2639-2653. doi: 10.1007/s00417-019-04464-2. Epub 2019 Oct 25. |
| 26581718 | Derived | Danis RP, Sadda S, Li XY, Cui H, Hashad Y, Whitcup SM. Anatomical effects of dexamethasone intravitreal implant in diabetic macular oedema: a pooled analysis of 3-year phase III trials. Br J Ophthalmol. 2016 Jun;100(6):796-801. doi: 10.1136/bjophthalmol-2015-306823. Epub 2015 Nov 18. |
| 26519345 | Derived | Augustin AJ, Kuppermann BD, Lanzetta P, Loewenstein A, Li XY, Cui H, Hashad Y, Whitcup SM; Ozurdex MEAD Study Group. Dexamethasone intravitreal implant in previously treated patients with diabetic macular edema: subgroup analysis of the MEAD study. BMC Ophthalmol. 2015 Oct 30;15:150. doi: 10.1186/s12886-015-0148-2. |
350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
| BG002 | Sham | Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 |
| Dexamethasone 350 μg |
350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months. |
| OG002 | Sham | Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months. |
|
|
| 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. | Intent to Treat: all randomized patients | Posted | Mean | Standard Deviation | Letters | Baseline, 39 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). A positive number change from baseline indicates an improvement and a negative number change from baseline indicates a worsening. | Intent to Treat: all randomized patients | Posted | Mean | Standard Deviation | Letters | Baseline, Month 39/Final Visit |
|
|
|
| Secondary | Percentage of Patients With a BCVA Improvement of ≥10 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. | Intent to Treat: all randomized patients | Posted | Number | Percentage of Patients | Baseline, Month 39/Final Visit |
|
|
|
| Secondary | Change From Baseline in Retinal Thickness as Measured by Optical Coherence Tomography (OCT) | 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 39/Final Visit |
|
|
|
| Post-Hoc | 10th Percentile for Time to 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). Shorter durations of time to improvement are best. The 10th percentile represents the first 10% of patients to reach a BCVA improvement of ≥15 letters from baseline in the study eye. | Intent to Treat: all randomized patients | Posted | Number | Days | Baseline, 39 Months |
|
|
|
| Post-Hoc | Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye at 3-month Intervals | 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. | Intent to Treat: all randomized patients | Posted | Number | Percentage of Patients | Baseline, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21, Month 24, Month 27, Month 30, Month 33, Month 36, Month 39/Final Visit |
|
|
|
| 63 |
| 187 |
| 180 |
| 187 |
| EG001 | Dexamethasone 350 μg | 350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months. | 68 | 178 | 172 | 178 |
| EG002 | Sham | Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months. | 49 | 186 | 157 | 186 |
| Anaemia | Blood and lymphatic system disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Anaemia of Chronic Disease | Blood and lymphatic system disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Coronary Artery Disease | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Acute Coronary Syndrome | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Cardiac Failure Congestive | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Myocardial Infarction | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Angina Unstable | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Acute Myocardial Infarction | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Myocardial Ischaemia | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Atrioventricular Block Second Degree | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Ischaemic Cardiomyopathy | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Mitral Valve Incompetence | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Cardiac Arrest | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Angina Pectoris | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Atrial Flutter | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Cardiac Disorder | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Cardiac Failure | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Coronary Artery Insufficiency | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Pulseless Electrical Activity | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Ventricular Fibrillation | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Atrioventricular Block | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Cardiomyopathy | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Vertigo Positional | Ear and labyrinth disorders | MedDRA version 15.0 | Non-systematic Assessment |
|
| Cataract | Eye disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Vitreous Haemorrhage | Eye disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Macular Oedema | Eye disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Macular Fibrosis | Eye disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Retinal Detachment | Eye disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Cataract Subcapsular | Eye disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Glaucoma | Eye disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Necrotising Retinitis | Eye disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Open Angle Glaucoma | Eye disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Cataract Cortical | Eye disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Cystoid Macular Oedema | Eye disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Diabetic Retinal Oedema | Eye disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Diabetic Retinopathy | Eye disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Hyalosis Asteroid | Eye disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Colonic Polyp | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Gastrointestinal Hypomotility | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Pancreatitis Acute | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA version 15.0 | Non-systematic Assessment |
|
| Faecaloma | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Gastric Ulcer | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Inguinal Hernia | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Abdominal Hernia | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Small Intestinal Perforation | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Pelvic Mass | General disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Medical Device Complication | General disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Multi-Organ Failure | General disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Sudden Death | General disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Chest Pain | General disorders | MedDRA version 15.0 | Non-systematic Assessment |
|
| Device Dislocation | General disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Cholecystitis Acute | Hepatobiliary disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Hepatic Cirrhosis | Hepatobiliary disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
|
| Endophthalmitis | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
|
| Osteomyelitis | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA version 15.0 | Non-systematic Assessment |
|
| Arthritis Bacterial | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
|
| Bronchopneumonia | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
|
| Staphylococcal Sepsis | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
|
| Incision Site Infection | Infections and infestations | MedDRA version 15.0 | Non-systematic Assessment |
|
| Labyrinthitis | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
|
| Pneumonia Viral | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
|
| Septic Shock | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
|
| Tuberculosis | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
|
| Gangrene | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
|
| Gallbladder Empyema | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
|
| Localised Infection | Infections and infestations | MedDRA version 15.0 | Non-systematic Assessment |
|
| Meniscus Lesion | Injury, poisoning and procedural complications | MedDRA version 15.0 | Systematic Assessment |
|
| Cartilage Injury | Injury, poisoning and procedural complications | MedDRA version 15.0 | Systematic Assessment |
|
| Humerus Fracture | Injury, poisoning and procedural complications | MedDRA version 15.0 | Systematic Assessment |
|
| Ligament Sprain | Injury, poisoning and procedural complications | MedDRA version 15.0 | Systematic Assessment |
|
| Fibula Fracture | Injury, poisoning and procedural complications | MedDRA version 15.0 | Systematic Assessment |
|
| Limb Injury | Injury, poisoning and procedural complications | MedDRA version 15.0 | Non-systematic Assessment |
|
| Road Traffic Accident | Injury, poisoning and procedural complications | MedDRA version 15.0 | Non-systematic Assessment |
|
| Tibia Fracture | Injury, poisoning and procedural complications | MedDRA version 15.0 | Systematic Assessment |
|
| Craniocerebral Injury | Injury, poisoning and procedural complications | MedDRA version 15.0 | Non-systematic Assessment |
|
| Femur Fracture | Injury, poisoning and procedural complications | MedDRA version 15.0 | Systematic Assessment |
|
| Comminuted Fracture | Injury, poisoning and procedural complications | MedDRA version 15.0 | Systematic Assessment |
|
| Femoral Neck Fracture | Injury, poisoning and procedural complications | MedDRA version 15.0 | Systematic Assessment |
|
| In-Stent Coronary Artery Restenosis | Injury, poisoning and procedural complications | MedDRA version 15.0 | Systematic Assessment |
|
| Lower Limb Fracture | Injury, poisoning and procedural complications | MedDRA version 15.0 | Systematic Assessment |
|
| Tendon Rupture | Injury, poisoning and procedural complications | MedDRA version 15.0 | Systematic Assessment |
|
| Spinal Compression Fracture | Injury, poisoning and procedural complications | MedDRA version 15.0 | Systematic Assessment |
|
| Diabetes Mellitus Inadequate Control | Metabolism and nutrition disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA version 15.0 | Non-systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA version 15.0 | Non-systematic Assessment |
|
| Meniscal Degeneration | Musculoskeletal and connective tissue disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Spinal Column Stenosis | Musculoskeletal and connective tissue disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Eagles Syndrome | Musculoskeletal and connective tissue disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA version 15.0 | Non-systematic Assessment |
|
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Foot Deformity | Musculoskeletal and connective tissue disorders | MedDRA version 15.0 | Non-systematic Assessment |
|
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA version 15.0 | Non-systematic Assessment |
|
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA version 15.0 | Non-systematic Assessment |
|
| Osteitis | Musculoskeletal and connective tissue disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Patellofemoral Pain Syndrome | Musculoskeletal and connective tissue disorders | MedDRA version 15.0 | Non-systematic Assessment |
|
| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 15.0 | Systematic Assessment |
|
| Benign Gastric Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 15.0 | Systematic Assessment |
|
| Bladder Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 15.0 | Systematic Assessment |
|
| Colon Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 15.0 | Systematic Assessment |
|
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 15.0 | Systematic Assessment |
|
| Lung Squamous Cell Carcinoma Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 15.0 | Systematic Assessment |
|
| Lung Squamous Cell Carcinoma Stage Unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 15.0 | Systematic Assessment |
|
| Ovarian Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 15.0 | Systematic Assessment |
|
| Transitional Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 15.0 | Systematic Assessment |
|
| Gastric Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 15.0 | Systematic Assessment |
|
| Hepatic Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 15.0 | Systematic Assessment |
|
| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 15.0 | Systematic Assessment |
|
| Chronic Lymphocytic Leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 15.0 | Systematic Assessment |
|
| Leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 15.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA version 15.0 | Non-systematic Assessment |
|
| Cerebrovascular Accident | Nervous system disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Transient Ischaemic Attack | Nervous system disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Carotid Artery Stenosis | Nervous system disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Altered State of Consciousness | Nervous system disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Benign Intracranial Hypertension | Nervous system disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Coma | Nervous system disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA version 15.0 | Non-systematic Assessment |
|
| Haemorrhage Intracranial | Nervous system disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Haemorrhagic Stroke | Nervous system disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Cerebral Ischaemia | Nervous system disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Ischaemic Stroke | Nervous system disorders | MedDRA version 15.0 | Systematic Assessment |
|
| VIIth Nerve Paralysis | Nervous system disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Cerebral Infarction | Nervous system disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Cervical Myelopathy | Nervous system disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Renal Failure Acute | Renal and urinary disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Renal Failure | Renal and urinary disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Cystitis Haemorrhagic | Renal and urinary disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Diabetic Nephropathy | Renal and urinary disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Renal Failure Chronic | Renal and urinary disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Calculus Ureteric | Renal and urinary disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Epididymitis | Reproductive system and breast disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Benign Prostatic Hyperplasia | Reproductive system and breast disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Uterine Haemorrhage | Reproductive system and breast disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Non-systematic Assessment |
|
| Respiratory Distress | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Non-systematic Assessment |
|
| Panniculitis | Skin and subcutaneous tissue disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA version 15.0 | Non-systematic Assessment |
|
| Victim of Homicide | Social circumstances | MedDRA version 15.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Malignant Hypertension | Vascular disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Extremity Necrosis | Vascular disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Deep Vein Thrombosis | Vascular disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Hypovolaemic Shock | Vascular disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Temporal Arteritis | Vascular disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Venous Insufficiency | Vascular disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Intraocular Pressure Increased | Investigations | MedDRA version 15.0 | Systematic Assessment |
|
| Conjunctival Haemorrhage | Eye disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Macular Oedema | Eye disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Visual Acuity Reduced | Eye disorders | MedDRA version 15.0 | Non-systematic Assessment |
|
| Cataract Subcapsular | Eye disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Diabetic Retinal Oedema | Eye disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Vitreous Haemorrhage | Eye disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Macular Fibrosis | Eye disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Ocular Hypertension | Eye disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Retinal Exudates | Eye disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Dry Eye | Eye disorders | MedDRA version 15.0 | Non-systematic Assessment |
|
| Vitreous Detachment | Eye disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Lenticular Opacities | Eye disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Retinal Haemorrhage | Eye disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
|
| Diabetic Retinopathy | Eye disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Conjunctival Oedema | Eye disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Conjunctival Hyperaemia | Eye disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Oedema Peripheral | General disorders | MedDRA version 15.0 | Non-systematic Assessment |
|
| Blood Creatinine Increased | Investigations | MedDRA version 15.0 | Systematic Assessment |
|
| Eye Pain | Eye disorders | MedDRA version 15.0 | Non-systematic Assessment |
|
| Punctate Keratitis | Eye disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Retinal Neovascularisation | Eye disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Cataract Cortical | Eye disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Retinal Aneurysm | Eye disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA version 15.0 | Non-systematic Assessment |
|
| Blepharitis | Eye disorders | MedDRA version 15.0 | Non-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 |
| 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 |
|
|
|
| Title | Measurements |
|---|---|
|
| Month 9 |
|
| Month 12 |
|
| Month 15 |
|
| Month 18 |
|
| Month 21 |
|
| Month 24 |
|
| Month 27 |
|
| Month 30 |
|
| Month 33 |
|
| Month 36 |
|
| Month 39/Final Visit |
|