Study of Brolucizumab in Adult Patients With Suboptimal Anatomically Controlled Neovascular Age-related Macular Degeneration (SWIFT)
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|ClinicalTrials.gov Identifier: NCT04264819|
Recruitment Status : Not yet recruiting
First Posted : February 11, 2020
Last Update Posted : July 16, 2020
Neovascular age-related macular degeneration is characterized by the presence of choroidal neovascularization (CNV), which consists of abnormal blood vessels originating from the choroid that can lead to hemorrhage, fluid exudation, and fibrosis, resulting in photoreceptor damage and vision loss.
The safety and efficacy of brolucizumab were assessed in 2 randomized, multicenter, double-masked, active treatment-controlled Phase 3 studies in nAMD patients (the HAWK study (RTH258-C001 [NCT02307682]) and the HARRIER study (RTH258-C002 [NCT02434328]). Accordingly, a new Phase 3b study (TALON, CRTH258A2303) is being conducted to evaluate the efficacy and safety of brolucizumab in a Treat-to-Control (TtC) regimen for the treatment of naïve patients with nAMD. In this TtC regimen, patients receive 3 consecutive injections every 4 weeks and then the injection interval is extended by 4 weeks up to a maximum of a 16-week interval. The decision to extend or reduce the injection interval is taken by the Investigator at each visit based on his/her judgment of disease activity, according to the patient visual and/or anatomic outcomes. If there is no disease activity, the injection interval can be extended by 4 weeks ; if disease activity occurs or recurs, the injection interval should be shortened accordingly by 4 weeks at a time or to a minimal interval of 4 weeks. The injection interval can also be maintained if the Investigator deems that the patient do not benefit from injection interval adjustment.
Since all these studies were conducted in a naïve nAMD patient population, no data are available on the efficacy and safety of brolucizumab in pretreated nAMD patients who still present active exudation.
|Condition or disease||Intervention/treatment||Phase|
|Neovascular Age-Related Macular Degeneration||Drug: RTH258/Brolucizumab||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||362 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single-arm, open-label study|
|Masking:||None (Open Label)|
|Official Title:||A One-year, Single-arm, Open-label, Multicenter Study Assessing the Effect of Brolucizumab on Disease Control in Adult Patients With Suboptimal Anatomically Controlled Neovascular Age-related Macular Degeneration (SWIFT)|
|Estimated Study Start Date :||September 21, 2020|
|Estimated Primary Completion Date :||September 9, 2021|
|Estimated Study Completion Date :||April 20, 2022|
This is a single arm study in which all patients will be treated with blolucizumab 6mg; 3 loading injections (at Screening/Baseline, week 4 and week 8) followed by treat-to-control phase with adjustable treatment frequency based on disease activity from every 4 to up to 16 weeks; last treatment at week 44/46 based on the treatment regimen.
Brolucizumab is a new generation of anti-VEGF (vascular endothelial growth factor). All patients will be treated with brolucizumab 6mg: 3 loading injections (at Screening/Baseline, Week 4 and Week 8), followed by Treat-to-Control regimen up to Week 44/46.
- Proportion of patients with no disease activity at Week 16 [ Time Frame: Week 16 ]To evaluate the effect of brolucizumab 6 mg on disease control
- Proportion of patients with no disease activity at Week 48 [ Time Frame: Week 48 ]To evaluate the long term effects of brolucizumab 6 mg on disease control
- Change from Baseline in CFST (Central Sub-Field Retinal Thickness) as assessed by OCT (Optical Coherence Tomography) over time up to Week 48 [ Time Frame: Week 48 ]To evaluate the effect of brolucizumab 6 mg on anatomical parameters
- Absence of IRF (Intraretinal Fluid), SRF (Subretinal Fluid), and sub-RPE (Retinal Pigmented Epithelium) fluid as assessed by OCT over time up to Week 48 [ Time Frame: Week 48 ]To evaluate the effect of brolucizumab 6 mg on anatomical parameters
- Proportion of patients with a dry retina (neither IRF nor SRF) up to Week 48 [ Time Frame: Week 48 ]To evaluate the effect of brolucizumab 6 mg on anatomical parameters
- Distribution of the last interval with no disease activity up to Week 48 [ Time Frame: Week 48 ]To evaluate the durability of brolucizumab 6 mg
- Distribution of the maximal intervals with no disease activity up to Week 48 [ Time Frame: Week 48 ]To evaluate the durability of brolucizumab 6 mg
- Average change in BCVA (Best-Corrected Visual Acuity) from Baseline up to Week 48 [ Time Frame: Week 48 ]To evaluate functional outcomes
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04264819
|Contact: Novartis Pharmaceuticalsemail@example.com|
|Contact: Novartis Pharmaceuticals|