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| Name | Class |
|---|---|
| Tigermed Consulting Co., Ltd | INDUSTRY |
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This study will evaluate the safety and efficacy of 700 μg dexamethasone versus laser photocoagulation in participants with diabetic macular edema (DME).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laser Photocoagulation | Other | Laser photocoagulation was administered in the study eye on Day 1, and on Months 3, 6, and 9, if retreatment indicated. |
|
| Dexamethasone | Experimental | Dexamethasone 700 μg was administered as intravitreal injection in the study eye on Day 1, Months 5, and 10. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | Dexamethasone 700 μg intravitreal injection in the study eye on Day 1, Months 5, and 10. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Average Change From Baseline (CFB) in Best Corrected Visual Acuity (BCVA) in the Study Eye | BCVA was measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The eligible eye with worse visual acuity was selected as the study eye. The average change was computed by subtracting the baseline BCVA from the area under the BCVA curve (AUC) divided by the total follow-up time for each participant. Analysis of covariance (ANCOVA) model was used for the analysis. | Baseline to Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With BCVA Improvement ≥15 Letters From Baseline in the Study Eye | BCVA was measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The eligible eye with worse visual acuity was selected as the study eye. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joanne Li | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Beijing | Beijing Municipality | 100034 | China | ||
| People's Hospital of Peking University |
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| ID | Title | Description |
|---|---|---|
| FG000 | Laser Photocoagulation | Laser photocoagulation was administered in the study eye on Day 1, and on Months 3, 6, and 9, if retreatment indicated. |
| FG001 | Dexamethasone | Dexamethasone 700 μg was administered as intravitreal injection in the study eye on Day 1, Months 5, and 10. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 13, 2020 | Oct 27, 2020 |
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| Laser Photocoagulation | Procedure | Laser photocoagulation on Day 1, and on Months 3, 6, and 9, if retreatment indicated. |
|
| Baseline to Month 12 |
| Change From Baseline in CRT by Spectral Domain Optical Coherence Tomography (SD-OCT) in the Study Eye | CRT was assessed using SD-OCT, a non-invasive diagnostic system that provides high-resolution imaging sections of the retina. SD-OCT is performed in the study eye after pupil dilation. A negative change from Baseline indicates improvement and a positive change from baseline indicates worsening. The eligible eye with worse visual acuity was selected as the study eye. ANCOVA model was used for the analysis. | Baseline to Month 12 |
| Change From Baseline in Total Macular Leakage Area by FA in the Study Eye | FA is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. Early and transit images were taken of the study eye. Mid- and late-phase images were taken of the study and non-study eye. Electronic FA images were collected for evaluation by a reading center. The eligible eye with worse visual acuity was selected as the study eye. ANCOVA model was used for the analysis. | Baseline to Month 12 |
| Beijing |
| Beijing Municipality |
| 100044 |
| China |
| Beijing Friendship Hospital of Capital Medical University | Beijing | Beijing Municipality | 100050 | China |
| Beijing Hospital | Beijing | Beijing Municipality | 100730 | China |
| Beijing TongRen Hospital | Beijing | Beijing Municipality | 100730 | China |
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | 100730 | China |
| Zhongshan Ophthalmic Center, Sun Yet-Sen University | Guangzhou | Guangdong | 510060 | China |
| Renmin Hospital of Wuhan University | Wuhan | Hubei | 430060 | China |
| The Second Xiangya Hospital of Central South University | Changsha | Hunan | 410011 | China |
| The First Hospital of Nanjing Medical University | Nanjing | Jiangsu | 210029 | China |
| The 2nd hospital of JiLin University | Changchun | Jilin | 130041 | China |
| The Eye and ENT Hospital, Affiliated of Fudan University | Shanghai | Shanghai Municipality | 200031 | China |
| West China Hospital, Sichuan University | Chengdu | Sichuan | 610041 | China |
| Tianjin Eye Hospital | Tianjin | Tianjin Municipality | 300020 | China |
| TianJin Medical University Eye Hospital | Tianjin | Tianjin Municipality | 300384 | China |
| Wenzhou Ophthalmic Centre | Wenzhou | Zhejiang | 325027 | China |
| Asian Eye Institute | Makati City | National Capital Region | 1200 | Philippines |
| Peregrine Eye and Laser Institute | Makati City | National Capital Region | 1209 | Philippines |
| Treated |
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| Modified Intent-to-treat Population |
|
| COMPLETED |
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| NOT COMPLETED |
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Modified Intent-to-treat (mITT) population included all randomized and treated participants with at least one postbaseline best corrected visual acuity (BCVA) measurement.
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| ID | Title | Description |
|---|---|---|
| BG000 | Laser Photocoagulation | Laser photocoagulation was administered in the study eye on Day 1, and on Months 3, 6, and 9, if retreatment indicated. |
| BG001 | Dexamethasone | Dexamethasone 700 μg was administered as intravitreal injection in the study eye on Day 1, Months 5, and 10. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| BCVA in the Study Eye | BCVA was measured using an eye chart and is reported as the number of letters read correctly using the early treatment diabetic retinopathy study (ETDRS) scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The eligible eye with worse visual acuity was selected as the study eye. | Mean | Standard Deviation | letters |
| ||||||||||||||
| Central Retinal Thickness (CRT) by Optical Coherence Tomography (OCT) in the Study Eye | CRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system that provides high-resolution imaging sections of the retina. SD-OCT is performed in the study eye after pupil dilation. The eligible eye with worse visual acuity was selected as the study eye. | Mean | Standard Deviation | microns |
| ||||||||||||||
| Total Macular Leakage Area by Fluorescein Angiography (FA) in the Study Eye | FA is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. Early and transit images were taken of the study eye. Mid- and late-phase images were taken of the study eye and non-study eye. Electronic FA images were collected for evaluation by a reading center to identify macular area of leakage. The eligible eye with worse visual acuity was selected as the study eye. | Data for Total Macular Leakage Area was only available for 125 participants in the Laser Photocoagulation arm. | Mean | Full Range | mm^2 |
|
| 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 | Percentage of Participants With BCVA Improvement ≥15 Letters From Baseline in the Study Eye | BCVA was measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The eligible eye with worse visual acuity was selected as the study eye. | mITT population included all randomized and treated participants with at least one postbaseline BCVA measurement. | Posted | Number | percentage of participants | Baseline to Month 12 |
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Average Change From Baseline (CFB) in Best Corrected Visual Acuity (BCVA) in the Study Eye | BCVA was measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The eligible eye with worse visual acuity was selected as the study eye. The average change was computed by subtracting the baseline BCVA from the area under the BCVA curve (AUC) divided by the total follow-up time for each participant. Analysis of covariance (ANCOVA) model was used for the analysis. | mITT population included all randomized and treated participants with at least one postbaseline BCVA measurement. | Posted | Least Squares Mean | Standard Error | letters | Baseline to Month 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in CRT by Spectral Domain Optical Coherence Tomography (SD-OCT) in the Study Eye | CRT was assessed using SD-OCT, a non-invasive diagnostic system that provides high-resolution imaging sections of the retina. SD-OCT is performed in the study eye after pupil dilation. A negative change from Baseline indicates improvement and a positive change from baseline indicates worsening. The eligible eye with worse visual acuity was selected as the study eye. ANCOVA model was used for the analysis. | mITT population included all randomized and treated participants with at least one postbaseline BCVA measurement. Last observation carried forward (LOCF) was used | Posted | Least Squares Mean | Standard Error | microns | Baseline to Month 12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Total Macular Leakage Area by FA in the Study Eye | FA is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. Early and transit images were taken of the study eye. Mid- and late-phase images were taken of the study and non-study eye. Electronic FA images were collected for evaluation by a reading center. The eligible eye with worse visual acuity was selected as the study eye. ANCOVA model was used for the analysis. | mITT population included all randomized and treated participants with at least one postbaseline BCVA measurement. LOCF was used. Overall number of participants analyzed is the number of participants with data available for analyses. | Posted | Least Squares Mean | Standard Error | mm^2 | Baseline to Month 12 |
|
|
From the first dose up to last dose (Up to Month 12)
Safety Population included all participants who received the study medication or had the study procedure performed on the study eye.
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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 | Laser Photocoagulation | Laser photocoagulation was administered in the study eye on Day 1, and on Months 3, 6, and 9, if retreatment indicated. | 1 | 129 | 21 | 129 | 51 | 129 |
| EG001 | Dexamethasone | Dexamethasone 700 μg was administered as intravitreal injection in the study eye on Day 1, Months 5, and 10. | 2 | 145 | 35 | 145 | 99 | 145 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA: 22.0 | Systematic Assessment |
| |
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA: 22.0 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA: 22.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA: 22.0 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA: 22.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA: 22.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA: 22.0 | Systematic Assessment |
| |
| Vitreous haemorrhage | Eye disorders | MedDRA: 22.0 | Systematic Assessment |
| |
| Diabetic retinopathy | Eye disorders | MedDRA: 22.0 | Systematic Assessment |
| |
| Glaucoma | Eye disorders | MedDRA: 22.0 | Systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA: 22.0 | Systematic Assessment |
| |
| Macular hole | Eye disorders | MedDRA: 22.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA: 22.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA: 22.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA: 22.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA: 22.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA: 22.0 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA: 22.0 | Systematic Assessment |
| |
| Cholecystitis chronic | Hepatobiliary disorders | MedDRA: 22.0 | Systematic Assessment |
| |
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA: 22.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA: 22.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA: 22.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA: 22.0 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA: 22.0 | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA: 22.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA: 22.0 | Systematic Assessment |
| |
| Foreign body in eye | Injury, poisoning and procedural complications | MedDRA: 22.0 | Systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA: 22.0 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA: 22.0 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA: 22.0 | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA: 22.0 | Systematic Assessment |
| |
| Intraocular pressure increased | Investigations | MedDRA: 22.0 | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA: 22.0 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA: 22.0 | Systematic Assessment |
| |
| Diabetic complication | Metabolism and nutrition disorders | MedDRA: 22.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA: 22.0 | Systematic Assessment |
| |
| Hepatic cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA: 22.0 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA: 22.0 | Systematic Assessment |
| |
| Diabetic neuropathy | Nervous system disorders | MedDRA: 22.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA: 22.0 | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA: 22.0 | Systematic Assessment |
| |
| Diabetic nephropathy | Renal and urinary disorders | MedDRA: 22.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA: 22.0 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA: 22.0 | Systematic Assessment |
| |
| Diabetic foot | Skin and subcutaneous tissue disorders | MedDRA: 22.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA: 22.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cataract | Eye disorders | MedDRA: 22.0 | Systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA: 22.0 | Systematic Assessment |
| |
| Ocular hypertension | Eye disorders | MedDRA: 22.0 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA: 22.0 | Systematic Assessment |
| |
| Vitreous haemorrhage | Eye disorders | MedDRA: 22.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA: 22.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA: 22.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA: 22.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA: 22.0 | Systematic Assessment |
| |
| Intraocular pressure increased | Investigations | MedDRA: 22.0 | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area, Head | Allergan | 714-246-4500 | clinicaltrials@allergan.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Apr 25, 2013 | Oct 27, 2020 | Prot_001.pdf |
| ID | Term |
|---|---|
| D008269 | Macular Edema |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D002123 | Calcium Dobesilate |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| 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 |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
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| Other |
|
| Units |
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| Counts |
|---|
| Participants |
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| Participants |
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