Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
IBI-20089/Lucentis · 1 trial · 2 indications
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.
| Arm | Type | Description |
|---|---|---|
| IBI-20089/Lucentis | EXPERIMENTAL | Alternate treatment of either 6.9 mg IBI-20089/Lucentis or 13.8 mg IBI-20089/Lucentis |
| Name | Type | Description |
|---|---|---|
| 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. |
Inclusion Criteria: 1. Male or Female subjects, 55 years of age and older. 2. Diagnosis of active, subfoveal choroidal neovascular membranes (CNVM) due to age related macular degeneration (AMD) 3. Visual acuity from 20/25 to 20/400 in the study eye. Exclusion Criteria: 1. Subjects who have receiv...
IBI-20089/Lucentis is used for the treatment of neovascular age-related macular degeneration (AMD), a condition that causes choroidal neovascularization and vision loss. It is administered as an intravitreal injection in combination with Lucentis, and it is currently being studied in a Phase 1 clinical trial.
IBI-20089/Lucentis is a small molecule being developed for ophthalmology. The specific molecular target of IBI-20089 is not disclosed in the available information. It is studied in combination with Lucentis, which targets vascular endothelial growth factor (VEGF), but the target of IBI-20089 itself is not specified.
IBI-20089/Lucentis is being developed by Icon Plc, a company traded on the NASDAQ under the ticker symbol ICLR. The drug is in Phase 1 clinical development for age-related macular degeneration.
IBI-20089/Lucentis is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. One Phase 1 trial has been completed, involving 10 participants with age-related macular degeneration and choroidal neovascularization.
IBI-20089/Lucentis has one completed clinical trial, identified as NCT01175395. This Phase 1 study evaluated the combination of 20089 and Lucentis via intravitreal injections for the treatment of neovascular age-related macular degeneration. The trial was conducted in the United States and enrolled 10 participants aged 55 years and older.
IBI-20089 is not the same as Lucentis. IBI-20089 is an investigational small molecule being developed by Icon Plc, while Lucentis is a separate drug. In the clinical trial, IBI-20089 is studied in combination with Lucentis, meaning they are distinct agents used together for treating age-related macular degeneration.