A Study to Assess the Effects of Brolucizumab in Adult Patients With Neovascular Age Related Macular Degeneration
OCTOPUS
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
2 other identifiers
interventional
210
1 country
40
Brief Summary
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 brolucizumab studies. This single-arm, open-label, multicenter study was performed to evaluate the efficacy and safety of brolucizumab 6 mg in patients with nAMD. OCT-A was 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 2021
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 21, 2020
CompletedFirst Posted
Study publicly available on registry
January 23, 2020
CompletedStudy Start
First participant enrolled
January 26, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 23, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 2, 2023
CompletedResults Posted
Study results publicly available
June 4, 2024
CompletedOctober 9, 2024
October 1, 2024
1.3 years
January 21, 2020
April 28, 2023
October 7, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage Change in Choroidal Neovascularization (CNV) Lesion Area Measured by Optical Coherence Tomography-Angiograph (OCT-A) From Baseline to Week 12
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.
Baseline, Week 12
Secondary Outcomes (12)
Percentage Change in Choroidal Neovascularization (CNV) Lesion Area Measured by Optical Coherence Tomography-Angiograph (OCT-A) From Baseline to Week 48
Baseline, Weeks 4, 8, 48
Change in Choroidal Neovascularization (CNV) Lesion Area Measured by Optical Coherence Tomography-Angiograph (OCT-A) From Baseline to Week 48
Baseline, Weeks 4, 8, 12, 48
Presence of Choroidal Neovascularization (CNV) Lesion Area Measured by Optical Coherence Tomography-Angiograph (OCT-A) From Baseline to Week 48
Baseline, Week 48
Change in Best Corrected Visual Acuity (BCVA) From Baseline up to Week 48
Baseline, Weeks 4, 8, 12, 48
Percentage of Patients Who Are Maintained on an Exclusive Treatment Interval Every 12 Weeks (q12w) Following the Loading Phase to Week 48
Weeks 20, 32, 44, 48
- +7 more secondary outcomes
Study Arms (1)
RTH258/Brolucizumab
EXPERIMENTALThis 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Patients must provide written informed consent before any study related procedures are performed.
- Patients must be 50 years of age or older at Screening/Baseline.
- Study eye:
- Active CNV lesions secondary to AMD that affect the central subfield, including retinal angiomatous proliferation (RAP) with a CNV component, confirmed by presence of active leakage from CNV seen by fluorescein angiography and sequellae of CNV, e.g. pigment epithelial detachment (PED), subretinal hemorrhage or sub-retinal pigment epithelium (sub-RPE) hemorrhage, blocked fluorescence, macular edema.
- Intra- and/or subretinal fluid affecting the central subfield of the study eye at Screening/Baseline.
- BCVA between 83 and 23 letters, inclusive, in the study eye at Screening/Baseline using early treatment diabetic retinopathy study (ETDRS) at an initial testing distance of 4 meters.
You may not qualify if:
- Ocular conditions:
- Any active intraocular or periocular infection or active intraocular inflammation (e.g. infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis) in either eye at Screening/Baseline.
- Presence of amblyopia, amaurosis or ocular disorders in the fellow eye with BCVA \< 35 ETDRS letters at Screening (except when due to conditions whose surgery may improve visual acuity, e.g. cataract).
- Medical history of intraocular inflammation and/or retinal vascular occlusion within 12 months prior to Screening/Baseline.
- Study eye:
- Poor quality of OCT-A and SD-OCT images at Screening/Baseline.
- Atrophy or fibrosis involving the center of the fovea in the study eye, as assessed by color fundus photography and fundus autofluorescence (FAF) at Screening/Baseline.
- The total area of fibrosis or subretinal blood affecting the foveal center point comprising ≥ 50% of the lesion area in the study eye at Screening/Baseline.
- Concomitant conditions or ocular disorders in the study eye, including retinal diseases other than nAMD, that, in the judgment of the investigator, could require medical or surgical intervention during the course of the study to prevent or treat visual loss that might result from that condition, or that limits the potential to gain visual acuity upon treatment with the investigational product.
- Structural damage within 0.5 disc diameter of the center of the macula in the study eye, e.g. vitreomacular traction, epiretinal membrane, retinal pigment epithelium (RPE) rip/tear scar, laser burn, at the time of Screening that in the investigator's opinion could preclude visual function improvement with treatment.
- Current vitreous hemorrhage or history of vitreous hemorrhage in the study eye within 4 weeks prior to Screening/Baseline.
- Uncontrolled glaucoma in the study eye defined as IOP \> 25 mmHg on medication or according to the investigator's judgment at Screening/Baseline.
- Aphakia and/or absence of the posterior capsule in the study eye at Screening/Baseline.
- Ocular treatments (study eye):
- Patient has received any approved or investigational treatment for nAMD (other than vitamin supplements) in the study eye at any time.
- +19 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
Novartis Investigative Site
Nice, Cedex1, 06001, France
Novartis Investigative Site
Rennes, FRA, 35033, France
Novartis Investigative Site
Saint-Cyr-sur-Loire, Indre Et Loire, 37540, France
Novartis Investigative Site
Lyon, Rhone, 69317, France
Novartis Investigative Site
Bobigny, Seine Saint Denis, 93009, France
Novartis Investigative Site
Aix-en-Provence, 13090, France
Novartis Investigative Site
Angers, 49044, France
Novartis Investigative Site
Avignon, 84000, France
Novartis Investigative Site
Bordeaux, 33000, France
Novartis Investigative Site
Boulogne-sur-Mer, 62321, France
Novartis Investigative Site
Caen, 14000, France
Novartis Investigative Site
Caen, 14033, France
Novartis Investigative Site
Créteil, 94000, France
Novartis Investigative Site
Dijon, 21034, France
Novartis Investigative Site
Floirac, 33270, France
Novartis Investigative Site
Grenoble, 38000, France
Novartis Investigative Site
La Rochelle, 17019, France
Novartis Investigative Site
Lagord, 17140, France
Novartis Investigative Site
Le Chesnay, 78157, France
Novartis Investigative Site
Lille, 59000, France
Novartis Investigative Site
Lyon, 69002, France
Novartis Investigative Site
Marseille, F 13008, France
Novartis Investigative Site
Montargis, 45200, France
Novartis Investigative Site
Montauban, 82000, France
Novartis Investigative Site
Montpellier, 34000, France
Novartis Investigative Site
Mulhouse, 68070, France
Novartis Investigative Site
Nantes, 44093, France
Novartis Investigative Site
Nantes, 44300, France
Novartis Investigative Site
Paris, 75007, France
Novartis Investigative Site
Paris, 75010, France
Novartis Investigative Site
Perpignan, 66000, France
Novartis Investigative Site
Plérin, 22190, France
Novartis Investigative Site
Poitiers, 86021, France
Novartis Investigative Site
Rouen, 76100, France
Novartis Investigative Site
Royan, 17200, France
Novartis Investigative Site
Rueil-Malmaison, 92500, France
Novartis Investigative Site
Saint-Herblain, 44819, France
Novartis Investigative Site
Saint-Martin-des-Champs, 50300, France
Novartis Investigative Site
Strasbourg, 67000, France
Novartis Investigative Site
Toulouse, 31059, France
Related Publications (1)
Bodaghi B, Souied EH, Tadayoni R, Weber M, Ponthieux A, Kodjikian L. Detection and Management of Intraocular Inflammation after Brolucizumab Treatment for Neovascular Age-Related Macular Degeneration. Ophthalmol Retina. 2023 Oct;7(10):879-891. doi: 10.1016/j.oret.2023.06.009. Epub 2023 Jun 19.
PMID: 37343623DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 21, 2020
First Posted
January 23, 2020
Study Start
January 26, 2021
Primary Completion
May 23, 2022
Study Completion
February 2, 2023
Last Updated
October 9, 2024
Results First Posted
June 4, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com