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RTH258/Brolucizumab · 3 trials · 2 indications
OCT-A is a dye-less angiographic procedure based on split-spectrum-decorrelation-amplitude angiography. It enables the capture of scattered intra-vessel particles (mainly erythrocyte cells) at all levels of the retinal and inner-choroidal vasculature, thus providing 3-D imaging of the retinal circulation. The literature suggests that OCT-A is a good marker for assessing anti-VEGF therapeutic response, especially lesion size. Inter-Quartile Range = q1 - q3.
Disease activity criteria were assessed by the Investigator based on whether neovascular age-related macular degeneration (nAMD) was still active or had been re-activated. The disease was defined as active if at least one of the following criteria was observed: * Best-corrected visual acuity (BCVA) decrease ≥ 5 letters from the best value since Baseline due to disease activity * Any significant increase in central retinal thickness (CRT) * Retinal hemorrhage * Intraretinal fluid or sub-retinal fluid (SRF) due to disease activity (degenerative cysts allowed) * Increase of sub-retinal pigmented epithelium (RPE) fluid These criteria were for guidance only, Investigators could define disease activity based on their own assessment.
The safety is defined as the incidence of ocular and non-ocular adverse events
| Arm | Type | Description |
|---|---|---|
| RTH258/Brolucizumab | EXPERIMENTAL | This is a single-arm study in which all patients will be treated with brolucizumab 6mg: 3 loading injections (at Screening/Baseline, Week 4 and Week 8), followed by maintenance treatment from Week 16/Week 20 up to Week 40/Week 44. |
| RTH258 | EXPERIMENTAL | brolucizumab 6 mg in a prefilled syringe |
| Name | Type | Description |
|---|---|---|
| RTH258/Brolucizumab | DRUG | Brolucizumab is a new generation of anti-VEGF (vascular endothelial growth factor). All patients were treated with brolucizumab 6mg: 3 loading injections (at Screening/Baseline, Week 4 and Week 8), followed by maintenance treatment every 8 weeks (Q8W) or every 12 weeks (Q12W) depending on disease activity from Week 16/Week20 to Week 40/Week 44. Brolucizumab was administered by an intravitreal (IVT) injection to the study. eye. |
| RTH258 | DRUG | 6 mg in prefilled syringe |
INCLUSION Criteria: 1. Patients must provide written informed consent before any study related procedures are performed. 2. Patients must be 50 years of age or older at Screening/Baseline. Study eye: 3. Active CNV lesions secondary to AMD that affect the central subfield, including retinal angi...
RTH258/Brolucizumab is used for neovascular age-related macular degeneration (nAMD), a chronic eye disease that causes vision loss due to abnormal blood vessel growth under the retina. It is being developed as a treatment for this condition and has been studied in adult patients aged 50 years and older.
RTH258/Brolucizumab is a small molecule designed to target and inhibit vascular endothelial growth factor (VEGF), a protein that promotes the growth of abnormal blood vessels in the eye. By blocking VEGF, it aims to reduce vessel leakage and swelling, potentially improving vision in patients with neovascular age-related macular degeneration.
RTH258/Brolucizumab is being developed by Novartis AG, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol NVS. Novartis is responsible for the clinical development and potential commercialization of this drug for neovascular age-related macular degeneration.
RTH258/Brolucizumab is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 3 trials have been completed, but the drug remains under investigation for its safety and efficacy in treating neovascular age-related macular degeneration.
RTH258/Brolucizumab has been studied in three completed Phase 3 trials: NCT03930641, NCT04239027, and NCT04264819. These trials evaluated the drug's safety and effects in patients with neovascular age-related macular degeneration, with enrollments of 34, 210, and 295 participants respectively, conducted in the United States and France.
Yes, RTH258/Brolucizumab is the same as brolucizumab. The name RTH258 is an investigational code, while brolucizumab is the generic name. Both refer to the same drug being developed by Novartis for neovascular age-related macular degeneration.