A Study to Assess the Effects of Brolucizumab in Adult Patients With Neovascular Age Related Macular Degeneration (OCTOPUS)
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|ClinicalTrials.gov Identifier: NCT04239027|
Recruitment Status : Not yet recruiting
First Posted : January 23, 2020
Last Update Posted : July 16, 2020
Neovascular age-related macular degeneration (nAMD) is characterized by the presence of choroidal neovascularization (CNV). Choroidal neovascularization consists of abnormal blood vessels originating from the choroid and can lead to hemorrhage, fluid exudation, and fibrosis, resulting in photoreceptor damage and vision loss.
The safety and efficacy of brolucizumab has been demonstrated in 2 randomized, multicenter, double-masked, active controlled Phase 3 studies in nAMD patients (RTH258-C001 and RTH258-C002). Anatomical changes were evaluated in these studies using spectral domain optical coherence tomography (SD-OCT), which relied on indirect parameters for the diagnosis of active CNV. The OCT-angiography (OCT A) that directly visualize retinal circulation and image CNV and vascular diseases of the retina was not included in previous brolcuizumab studies.
This single-arm, open-label, multicenter study is being performed to evaluate the efficacy and safety of brolucizumab 6 mg in patients with nAMD.
OCT-A will be used in this study to assess the morphological response of patients to brolucizumab in terms of percentage change in CNV lesion area in the short term (i.e. at Week 12) and in the long term (i.e. at Week 48), as well as changes in other OCT-A features up to Week 48.
Approximately 428 adult patients will be screened and included in approximately 75 centers in France.
The maximum study duration for 1 patient is 48 weeks.
Patients will be required to attend 6 mandatory study visits: Screening/Baseline Visit (Day 1), Week 4, Week 8, Week 12, Week 16 and Week 48 visits. The timing of the interim visits between Week 16 and Week 48 will depend on the patient's injection regimen, i.e. every 8 weeks or every 12 weeks according to disease activity assessed by the investigator.
|Condition or disease||Intervention/treatment||Phase|
|Neovascular Age Related Macular Degeneration||Drug: RTH258/Brolucizumab||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||428 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 Anatomic Outcomes of Brolucizumab Assessed by OCT-A in Adult Patients With Neovascular Age Related Macular Degeneration|
|Estimated Study Start Date :||September 21, 2020|
|Estimated Primary Completion Date :||November 15, 2021|
|Estimated Study Completion Date :||June 1, 2022|
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.
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 maintenance treatment from Week 16/Week 20 up to Week 40/Week 44.
- Percentage change in CNV lesion area measured by OCT-A from Baseline to Week 12 [ Time Frame: Week 12 ]To evaluate the short-term effect of brolucizumab on CNV lesion area as measured by Optical Coherence Tomography Angiography (OCT-A) in nAMD patients.
- Percentage change in CNV lesion area measured by OCT-A from Baseline to Week 48 [ Time Frame: Week 48 ]To evaluate the long-term effects of brolucizumab on Choroidal Neovascularization (CNV) morphology as measured by OCT-A in nAMD patients.
- Change in OCT-A features assessed by qualitative and quantitative criteria from Baseline by visit at Week 12 up to Week 48 [ Time Frame: Week 48 ]To evaluate the long-term effects of brolucizumab on Choroidal Neovascularization (CNV) morphology as measured by OCT-A in nAMD patients.
- Change in SD-OCT and FA features assessed by qualitative and quantitative criteria: Central Sub-Field Retinal Thickness (CSFT), sub and/or intraretinal fluid, sub-RPE (Retinal Pigmented Epithelium) fluid from Baseline by visit up to Week 48 [ Time Frame: Week 48 ]To evaluate the effect of brolucizumab on anatomical parameters as assessed by Spectral Domain Optical Coherence Tomography (SD-OCT) and Fluorescein Angiography (FA) from Week 12 up to Week 48.
- Change in Best Corrected Visual Acuity (BCVA) from Baseline up to Week 48 [ Time Frame: Week 48 ]To evaluate the efficacy of brolucizumab up to Week 48 by assessing changes in BCVA.
- Proportion of patients who are maintained on an exclusive treatment interval every 12 weeks (q12w) following the loading phase through to Week 48 [ Time Frame: Week 48 ]To estimate the proportion of patients treated at q12w frequency with brolucizumab.
- The probability of the first q12w interval for determining successful q12w maintenance at Week 48 [ Time Frame: Week 48 ]To estimate the predictive value of the first q12w cycle for maintenance of q12w treatment with brolucizumab.
- Time from last Intravitreal (IVT) injection in the initiation phase to first visit with no disease activity. [ Time Frame: Week 8 until Week 48 ]To evaluate the time from last IVT injection in the initiation phase to first visit with no disease activity.
- Change in self-completed auto evaluation tool from Baseline through to Week 48 [ Time Frame: Week 48 ]To describe Patient Reported Outcomes (PROs) collected by auto-evaluation tools.
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): NCT04239027
|Contact: Novartis Pharmaceuticalsemail@example.com|
|Contact: Novartis Pharmaceuticals|