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Also known as RTH258
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, also known as brolucizumab, is an investigational monoclonal antibody developed by Novartis AG for neovascular age-related macular degeneration, an eye condition in the ophthalmology therapeutic area. It has been studied in Phase 3 clinical trials. It is not described as approved, so it remains in clinical development.
RTH258, or brolucizumab, is being studied for the treatment of neovascular age-related macular degeneration, an ophthalmology condition. All three of its listed Phase 3 trials enrolled adults with this indication. The trials are completed, and the drug remains investigational rather than an approved therapy.
Brolucizumab, also called RTH258, is developed by Novartis AG, which trades under the ticker NVS. Novartis is the sponsor behind the Phase 3 clinical program evaluating the monoclonal antibody in neovascular age-related macular degeneration.
RTH258, or brolucizumab, is in Phase 3 clinical development. Three Phase 3 trials have been conducted, and all three are listed as completed. The drug is investigational and is not described as FDA approved for neovascular age-related macular degeneration.
Three completed Phase 3 trials have studied brolucizumab, also known as RTH258, in neovascular age-related macular degeneration. They are NCT04264819 with 295 patients in France, NCT04239027 with 210 patients in France, and NCT03930641, a safety study of the 6 mg prefilled syringe with 34 patients in the United States.
Yes, RTH258 and brolucizumab are two names for the same monoclonal antibody developed by Novartis AG. RTH258 is the code name, while brolucizumab is the drug name. Both refer to the Phase 3 investigational therapy for neovascular age-related macular degeneration.