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Study C11-01 started
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This study will test the efficacy and safety of IBI-10090 in the treatment of ocular inflammation after cataract surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose 1 | Experimental | 513ug |
|
| Dose 2 | Experimental | 776ug |
|
| Dose 3 | Experimental | 1046ug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBI-10090 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients With Anterior Chamber Cell Clearing at Day 8 Post-Treatment | This study will measure as its primary endpoint the anterior chamber cell count at Day 8 post-treatment in the study eye. The proportion of patients with anterior chamber cell count = 0 at Day 8 in the study eye for each dosage group will be compared. Only one eye was treated per participant. | 8 days post-treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Packer, MD | Drs. Fine, Hoffman, Packer | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Drs. Fine, Hoffman, and Packer | Eugene | Oregon | 97401 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dose 1 | IBI-10090 513ug |
| FG001 | Dose 2 | IBI-10090 776ug |
| FG002 | Dose 3 | IBI-10090 1046ug |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dose 1 | IBI-10090 513ug |
| BG001 | Dose 2 | IBI-10090 776ug |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Proportion of Patients With Anterior Chamber Cell Clearing at Day 8 Post-Treatment | This study will measure as its primary endpoint the anterior chamber cell count at Day 8 post-treatment in the study eye. The proportion of patients with anterior chamber cell count = 0 at Day 8 in the study eye for each dosage group will be compared. Only one eye was treated per participant. | Posted | Number | 95% Confidence Interval | percentage of patients with ACC clearing | 8 days post-treatment |
|
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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 | Dose 1 | IBI-10090 513ug |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neovascular age-related macular degeneration | Eye disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye Disorders | Eye disorders |
|
Early termination leading to small numbers of subjects analyzed
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wendy Murahashi, MD | Icon Bioscience, Inc. | 650-369-4049 | wendymurahashi@iconbioscience.com |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Dose 3 |
IBI-10090 1046ug |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Dose 3 |
IBI-10090 1046ug |
|
|
| 0 |
| 13 |
| 10 |
| 13 |
| EG001 | Dose 2 | IBI-10090 776ug | 1 | 16 | 13 | 16 |
| EG002 | Dose 3 | IBI-10090 1046ug | 3 | 13 | 13 | 13 |
| Pneumonia | Respiratory, thoracic and mediastinal disorders |
|
| Rib fracture | Musculoskeletal and connective tissue disorders |
|
| Endophthalmitis | Eye disorders |
|
| Infections and Infestations | Infections and infestations |
|
| Investigations | Investigations |
|
| Back pain | Musculoskeletal and connective tissue disorders |
|
| Headache | Nervous system disorders |
|
All information related to this study is considered confidential information belonging to Icon Bioscience, Inc. Data on the use of the study drug and results of all clinical and laboratory studies are considered private and confidential. None of the details, results, or other information for this study shall be published or made known to a third party without written consent from Icon Bioscience, Inc., except for disclosure to regulatory agencies if required by law.