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| Name | Class |
|---|---|
| ICON Bioscience Inc | INDUSTRY |
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The primary purpose of this study is to assess the safety & tolerability of an investigational drug 20089 TA (6.9 mg or 13.8 mg) when used adjunctively with Lucentis 0.5 mg in subjects with sub-foveal neovascular AMD.
The study is being done to test the safety and effectiveness of an investigational drug 20089 TA that will be used in combination with Lucentis for the treatment of CNVM. In CNVM, tiny abnormal blood vessels grow through the retinal layers in the eye. These vessels are very fragile and can leak or bleed. The severity of the symptoms depends on the size of the CNVM and its proximity to the macula (the center of visual field). Symptoms may be mild such as a blurry or distorted area of vision, or more severe, like a central blind spot. Although Lucentis has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of CNVM, the study drug 20089 TA has not yet been approved, and therefore is considered an investigational drug.
Triamcinolone Acetonide (TA) is a corticosteroid (an anti-inflammatory drug) that is used to treat many eye diseases, such as: macular edema (where inflammation causes thickening of the macula), diabetic eye disease, and age-related macular degeneration. TA has also been shown to be effective in treating neovascular AMD (also known as "wet AMD") where there is an abnormal growth of blood vessels in the macula.
Study drug 20089 is an experimental form of the corticosteroid, Triamcinolone Acetonide(TA). 20089 is a new slow-release formula (longer lasting) for intravitreal (into the eye) delivery of TA. This drug releases the active agent TA over a period of approximately 6 months thereby allowing for the improvement of inflammation and/or complications following neovascular AMD.
Although intravitreal Lucentis has been shown to prevent the loss of vision in most neovascular AMD patients and help gain visual acuity (how well we can see), results can only be assured if monthly injections are given. Since monthly injections are a burden on the patient and caregiver, attempts are being made to reduce the burden by combining available treatment options. We hope that by combining 20089 TA with Lucentis a decrease in retinal inflammation, closure of the leaky vessels with a decrease in the number of monthly injections could be achieved.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBI-20089/Lucentis | Experimental | Alternate treatment of either 6.9 mg IBI-20089/Lucentis or 13.8 mg IBI-20089/Lucentis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBI-20089/Lucentis | Drug | Combining a single dose of IBI-20089 (6.9 mg or 13.8 mg) intravitreal injection adjunctively with Lucentis 0.5 mg intravitreal injection at baseline and monthly intravitreal Lucentis injection PRN based on clinical and OCT results. |
| Measure | Description | Time Frame |
|---|---|---|
| To Assess the Safety & Tolerability of 20089 TA (6.9 mg or 13.8 mg) When Used Adjunctively With Lucentis 0.5 mg in Subjects With Sub-foveal Neovascular AMD | The primary objective is to assess the ocular safety of 20089 TA (6.9 mg or 13.8 mg)treatment in combination with Lucentis. The ocular safety endpoints to be assessed include the number of participants with ocular Adverse Events such as: evidence of endophthalmitis, uveitis, ocular hemorrhage, retinal tear or detachment to be assessed during ophthalmic examinations. Elevated IOP as measured by an applanation tonometer at every visit. | 360 Days |
| Measure | Description | Time Frame |
|---|---|---|
| To Determine the Number of Retreatments With Lucentis in Eyes Initially Treated With 20089 TA and Lucentis | Because of the combination - 20089/Lucentis - treatment, patients may not require monthly Lucentis injections as is the current standard of care practice for AMD. | 30 to 360 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer I Lim, MD | University of Illinois at Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UIC Eye and Ear Infirmary | Chicago | Illinois | 60612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25376617 | Derived | Lim JI, Niec M, Wong V. One year results of a phase 1 study of the safety and tolerability of combination therapy using sustained release intravitreal triamcinolone acetonide and ranibizumab for subfoveal neovascular AMD. Br J Ophthalmol. 2015 May;99(5):618-23. doi: 10.1136/bjophthalmol-2014-306002. Epub 2014 Nov 6. |
| Label | URL |
|---|---|
| UIC-Ophthalmology Home Page | View source |
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Patients were recruited from Sept 2010 to January 2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | IBI-20089/Lucentis | Alternate treatment of either 6.9 mg IBI-20089/Lucentis or 13.8 mg IBI-20089/Lucentis IBI-20089/Lucentis : Combining a single dose of IBI-20089 (6.9 mg or 13.8 mg) intravitreal injection adjunctively with Lucentis 0.5 mg intravitreal injection at baseline and monthly intravitreal Lucentis injection PRN based on clinical and OCT results. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | IBI-20089/Lucentis | Alternate treatment of either 6.9 mg IBI-20089/Lucentis or 13.8 mg IBI-20089/Lucentis IBI-20089/Lucentis : Combining a single dose of IBI-20089 (6.9 mg or 13.8 mg) intravitreal injection adjunctively with Lucentis 0.5 mg intravitreal injection at baseline and monthly intravitreal Lucentis injection PRN based on clinical and OCT results. |
| 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 | Participants |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | 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 | To Assess the Safety & Tolerability of 20089 TA (6.9 mg or 13.8 mg) When Used Adjunctively With Lucentis 0.5 mg in Subjects With Sub-foveal Neovascular AMD | The primary objective is to assess the ocular safety of 20089 TA (6.9 mg or 13.8 mg)treatment in combination with Lucentis. The ocular safety endpoints to be assessed include the number of participants with ocular Adverse Events such as: evidence of endophthalmitis, uveitis, ocular hemorrhage, retinal tear or detachment to be assessed during ophthalmic examinations. Elevated IOP as measured by an applanation tonometer at every visit. | Posted | Number | Number-participants with adverse events | 360 Days |
|
|
| |||||||||||||||||||||||||||
| Secondary | To Determine the Number of Retreatments With Lucentis in Eyes Initially Treated With 20089 TA and Lucentis | Because of the combination - 20089/Lucentis - treatment, patients may not require monthly Lucentis injections as is the current standard of care practice for AMD. | Posted | Median | Full Range | retreatments | 30 to 360 days |
|
|
1 year
Number of subjects who developed progression of cataract Number of subjects with intraocular pressure (IOP) elevation above 25 mmHg Number of subjects with any severe ocular adverse event Number of subjects with any severe systemic adverse event
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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 | IBI-20089/Lucentis | Alternate treatment of either 6.9 mg IBI-20089/Lucentis or 13.8 mg IBI-20089/Lucentis IBI-20089/Lucentis : Combining a single dose of IBI-20089 (6.9 mg or 13.8 mg) intravitreal injection adjunctively with Lucentis 0.5 mg intravitreal injection at baseline and monthly intravitreal Lucentis injection PRN based on clinical and OCT results. | 1 | 10 | 7 | 10 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| fracture of sacrum | Musculoskeletal and connective tissue disorders | SNOMED CT | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ocular hypertension | Eye disorders | SNOMED CT | Systematic Assessment |
| |
| subconjunctival hemorrhage | Eye disorders | SNOMED CT | Systematic Assessment |
| |
| cataract surgery | Eye disorders | SNOMED CT | Systematic Assessment |
| |
| vitreous floaters | Eye disorders | SNOMED CT | Systematic Assessment |
| |
| temporal pallor of optic nerve | Eye disorders | SNOMED CT | Systematic Assessment | Secondary and due to retinal atrophy. |
|
| posterior vitreous detachment | Eye disorders | SNOMED CT | Systematic Assessment |
| |
| retinal hemorrhage | Eye disorders | SNOMED CT | Systematic Assessment |
| |
| infective vaginitis | Reproductive system and breast disorders | SNOMED CT | Non-systematic Assessment | Unrelated to eye condition or treatment. |
|
| ptosis of eyelid | Eye disorders | SNOMED CT | Systematic Assessment |
| |
| food poisoning | Gastrointestinal disorders | SNOMED CT | Non-systematic Assessment |
| |
| anxiety | Psychiatric disorders | SNOMED CT | Non-systematic Assessment |
| |
| watery eye | Eye disorders | SNOMED CT | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer I Lim MD | University of Illinois at Chicago | 312-413-0704 | jennylim@uic.edu |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D020256 | Choroidal Neovascularization |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D015862 | Choroid Diseases |
| D014603 | Uveal Diseases |
| D009389 | Neovascularization, Pathologic |
| D008679 | Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| D014222 | Triamcinolone Acetonide |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D014221 | Triamcinolone |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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