Neovascular Age-Related Macular Degeneration
Conditions
Keywords
Macular degeneration, age-related macular degeneration (ARMD), vision loss, macula damage, retina damage, dry macular degeneration, wet macular degeneration, AMD, diabetic macular edema, DME, neovascular age-related macular degeneration, nAMD, retinal vein occlusion, RVO, wetAMD, neovascular, choroidal neovascularization, disease control
Brief summary
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.
Detailed description
This is a prospective, single-arm, open-label, multicenter study to evaluate the efficacy and safety of brolucizumab 6 mg in pretreated suboptimal anatomically controlled patients with neovascular age-related macular degeneration (nAMD).
Interventions
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.
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single-arm, open-label study
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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 nAMD diagnosed \< 18 months prior to Screening/Baseline that affect the central subfield, including retinal angiomatous proliferation (RAP) with a CNV component, confirmed by presence of active leakage from CNV seen by FA and sequelae of CNV, e.g. pigment epithelial detachment (PED), subretinal hemorrhage or sub RPE hemorrhage, blocked fluorescence, or macular edema. 4. Previous treatment with only one licensed anti-VEGF drug (i.e. Lucentis®, Eylea®) with a ≥ Q4 and ≤ Q8 treatment (treatment interval of 26 to 62 days inclusive) with licensed anti-VEGF (a minimal washout period of at least 4 weeks / 26 days is required). Patients must have received at least 3 injections of this anti-VEGF in the 6 months prior to Screening/Baseline. 5. Presence of residual fluid (IRF or SRF that affects the central subfield under, as seen by OCT) 6. BCVA score must be ≤ 83 and ≥ 38 letters at an initial testing distance of 4 meters starting distance using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity charts at Screening/Baseline.
Exclusion criteria
Ocular conditions 1. 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. 2. Presence of amblyopia, amaurosis, or ocular disorders in the fellow eye with BCVA \< 35 ETDRS letters at Screening/Baseline (except when due to conditions whose surgery may improve visual acuity, e.g. cataract). 3. Medical history of intraocular inflammation and/or retinal vascular occlusion within 12 months prior to Screening/Baseline Study eye 4. Poor quality of OCT image at Screening/Baseline. 5. Atrophy or fibrosis involving the center of the fovea in the study eye, as assessed by CFP and fundus autofluorescence (FAF). 6. The total area of fibrosis or subretinal blood affecting the foveal center point comprising ≥ 50% of the lesion area in the study eye. 7. 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. 8. Structural damage within 0.5 disc diameter of the center of the macula in the study eye, e.g. vitreomacular traction, epiretinal membrane, RPE rip/tear scar, laser burn, at the time of Screening/Baseline that in the Investigator's opinion could preclude visual function improvement with treatment. 9. Current vitreous hemorrhage or history of vitreous hemorrhage in the study eye within 4 weeks prior to Screening/Baseline. 10. Uncontrolled glaucoma in the study eye defined as IOP \> 25 mmHg on medication or according to the Investigator's judgment, at Screening/Baseline. 11. Aphakia and/or absence of the posterior capsule in the study eye. Ocular treatments (study eye) 12. Patient has received any investigational treatment for nAMD (other than vitamin supplements) in the study eye at any time. 13. Previous use of intraocular or periocular of corticosteroids in the study eye within the 6 month period prior to Screening/Baseline. 14. Previous penetrating keratoplasty or vitrectomy at any time prior to Screening/Baseline. 15. History or evidence of the following in the study eye within the 90-day period prior to Screening/Baseline: * Intraocular or refractive surgery. * Previous panretinal and peripheral laser photocoagulation. * Previous macular surgery or other intraocular surgical intervention 16. Previous laser treatment for nAMD including photodynamic therapy (PDT) laser at any time prior to Screening/Baseline. 17. Previous treatment with investigational drugs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With no Disease Activity at Week 16 in the Study Eye | Week 16 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in CFST (Central Sub-Field Retinal Thickness) as Assessed by OCT (Optical Coherence Tomography) Over Time up to Week 48 in the Study Eye | Baseline, Weeks 4,8,16, 48 | Central Subfield Thickness Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center. |
| 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 in the Study Eye | Baseline, Week 4, 8, 16, 48 | Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center. At week 8, for 1 patient, the fluid assessment was performed, but result is unknown; at week 16, for 1 patient, the fluid assessment was performed, but result is unknown; at week 48, for 2 patients, the fluid assessment was performed, but result is unknown. |
| Number of Patients With a Dry Retina (Neither IRF Nor SRF) up to Week 48 in the Study Eye | Baseline, Weeks 4, 8, 16, 48 | Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center. |
| Distribution of the Last Interval With no Disease Activity up to Week 48 in the Study Eye | Intervals of 0,4,5,6,7,8,9,10,11,12,13,14,15,16,17 Weeks | 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. |
| Number of Patients With no Disease Activity at Week 48 in the Study Eye | Week 48 | 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. |
| Average Change in BCVA (Best-Corrected Visual Acuity) From Baseline up to Week 48 in the Study Eye | Baseline, Weeks 4, 8, 16, 48 | BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual Function of the study eye was assessed using the ETDRS protocol. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning. |
| Summary of Treatment-emergent Adverse Events - Overall | Adverse events were reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum duration of 52 weeks. | An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study. |
| Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye) | Adverse events were reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum duration of 52 weeks. | An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study. |
| Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Non-ocular | Adverse events were reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum duration of 52 weeks. | An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study. |
| Distribution of the Maximal Intervals With no Disease Activity up to Week 48 in the Study Eye | Intervals of 0,4,5,6,7,8,9,10,11,12,13,14,15,16,17 Weeks | 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. |
Countries
France
Participant flow
Pre-assignment details
Before inclusion, patients underwent a 4-to-8-Week Washout Period (from 26 to 62 days) from the last administration of a licensed anti-VEGF drug (i.e., Lucentis®, Eylea®).
Participants by arm
| Arm | Count |
|---|---|
| RTH258/Brolucizumab This is a single arm study in which all patients are treated with brolucizumab 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 8 to up to 16 weeks; last treatment at week 44/46 based on the treatment regimen. | 295 |
| Total | 295 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 12 |
| Overall Study | Death | 2 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Physician Decision | 19 |
| Overall Study | Withdrawal by Subject | 11 |
Baseline characteristics
| Characteristic | RTH258/Brolucizumab | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 273 Participants | — |
| Age, Categorical Between 18 and 65 years | 22 Participants | — |
| Age, Continuous | 76.2 Years STANDARD_DEVIATION 8.13 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 183 Participants | — |
| Sex: Female, Male Male | 112 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 295 |
| other Total, other adverse events | 148 / 295 |
| serious Total, serious adverse events | 28 / 295 |
Outcome results
Primary
Number of Patients With no Disease Activity at Week 16 in the Study Eye
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.
Time frame: Week 16
Population: Full Analysis Set - The full analysis set (FAS) comprises all patients who received at least one IVT injection of study treatment without protocol deviation with impact and with an assessment of disease activity at Week 16.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RTH258/Brolucizumab | Number of Patients With no Disease Activity at Week 16 in the Study Eye | 89 Participants |
Secondary
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 in the Study Eye
Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center. At week 8, for 1 patient, the fluid assessment was performed, but result is unknown; at week 16, for 1 patient, the fluid assessment was performed, but result is unknown; at week 48, for 2 patients, the fluid assessment was performed, but result is unknown.
Time frame: Baseline, Week 4, 8, 16, 48
Population: Full Analysis Set - The full analysis set (FAS) comprises all patients who received at least one IVT injection of study treatment without protocol deviation with impact
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RTH258/Brolucizumab | 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 in the Study Eye | Baseline - Intraretinal fluid | 104 Participants |
| RTH258/Brolucizumab | 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 in the Study Eye | Baseline - Subretinal fluid | 245 Participants |
| RTH258/Brolucizumab | 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 in the Study Eye | Baseline - Sub-RPE fluid | 204 Participants |
| RTH258/Brolucizumab | 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 in the Study Eye | Baseline - Without any fluid (IRF/SRF) | 4 Participants |
| RTH258/Brolucizumab | 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 in the Study Eye | Baseline - With any fluid (IRF/SRF) | 285 Participants |
| RTH258/Brolucizumab | 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 in the Study Eye | Week 4 - Intraretinal fluid (n=260) | 61 Participants |
| RTH258/Brolucizumab | 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 in the Study Eye | Week 4 - Subretinal fluid (n=260) | 102 Participants |
| RTH258/Brolucizumab | 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 in the Study Eye | Week 4 - Sub-RPE fluid (n=260) | 102 Participants |
| RTH258/Brolucizumab | 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 in the Study Eye | Week 4 - Without any fluid (IRF/SRF) (n=260) | 114 Participants |
| RTH258/Brolucizumab | 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 in the Study Eye | Week 4 - With any fluid (IRF/SRF) (n=260) | 146 Participants |
| RTH258/Brolucizumab | 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 in the Study Eye | Week 8 - Intraretinal fluid (n=229) | 50 Participants |
| RTH258/Brolucizumab | 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 in the Study Eye | Week 8 - Subretinal fluid (n=229) | 72 Participants |
| RTH258/Brolucizumab | 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 in the Study Eye | Week 8 - Sub-RPE fluid (n=229) | 74 Participants |
| RTH258/Brolucizumab | 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 in the Study Eye | Week 8 - Without any fluid (IRF/SRF) (n=229) | 122 Participants |
| RTH258/Brolucizumab | 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 in the Study Eye | Week 8 - With any fluid (IRF/SRF) (n=229) | 106 Participants |
| RTH258/Brolucizumab | 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 in the Study Eye | Week 16 - Intraretinal fluid (n=222) | 70 Participants |
| RTH258/Brolucizumab | 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 in the Study Eye | Week 16 - Subretinal fluid (n=222) | 117 Participants |
| RTH258/Brolucizumab | 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 in the Study Eye | Week 16 - Sub-RPE fluid (n=222) | 99 Participants |
| RTH258/Brolucizumab | 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 in the Study Eye | Week 16 - Without any fluid (IRF/SRF) (n=222) | 69 Participants |
| RTH258/Brolucizumab | 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 in the Study Eye | Week 16 - With any fluid (IRF/SRF) (n=222) | 152 Participants |
| RTH258/Brolucizumab | 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 in the Study Eye | Week 48 - Intraretinal fluid (n=198) | 64 Participants |
| RTH258/Brolucizumab | 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 in the Study Eye | Week 48 - Subretinal fluid (n=198) | 84 Participants |
| RTH258/Brolucizumab | 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 in the Study Eye | Week 48 - Sub-RPE fluid (n=198) | 85 Participants |
| RTH258/Brolucizumab | 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 in the Study Eye | Week 48 - Without any fluid (IRF/SRF) (n=198) | 80 Participants |
| RTH258/Brolucizumab | 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 in the Study Eye | Week 48 - With any fluid (IRF/SRF) (n=198) | 116 Participants |
Secondary
Average Change in BCVA (Best-Corrected Visual Acuity) From Baseline up to Week 48 in the Study Eye
BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual Function of the study eye was assessed using the ETDRS protocol. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning.
Time frame: Baseline, Weeks 4, 8, 16, 48
Population: Full Analysis Set - The full analysis set (FAS) comprises all patients who received at least one IVT injection of study treatment without protocol deviation with impact with at least one valid post baseline assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RTH258/Brolucizumab | Average Change in BCVA (Best-Corrected Visual Acuity) From Baseline up to Week 48 in the Study Eye | Week 4 | 2.6 Letters read | Standard Deviation 6.09 |
| RTH258/Brolucizumab | Average Change in BCVA (Best-Corrected Visual Acuity) From Baseline up to Week 48 in the Study Eye | Week 8 (n=231) | 4.1 Letters read | Standard Deviation 6.68 |
| RTH258/Brolucizumab | Average Change in BCVA (Best-Corrected Visual Acuity) From Baseline up to Week 48 in the Study Eye | Week 16 (n=218) | 4.1 Letters read | Standard Deviation 7.41 |
| RTH258/Brolucizumab | Average Change in BCVA (Best-Corrected Visual Acuity) From Baseline up to Week 48 in the Study Eye | Week 48 (n=199) | 3.2 Letters read | Standard Deviation 9.22 |
Secondary
Change From Baseline in CFST (Central Sub-Field Retinal Thickness) as Assessed by OCT (Optical Coherence Tomography) Over Time up to Week 48 in the Study Eye
Central Subfield Thickness Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center.
Time frame: Baseline, Weeks 4,8,16, 48
Population: Full Analysis Set - The full analysis set (FAS) comprises all patients who received at least one IVT injection of study treatment without protocol deviation with impact and had at least one valid post-baseline assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RTH258/Brolucizumab | Change From Baseline in CFST (Central Sub-Field Retinal Thickness) as Assessed by OCT (Optical Coherence Tomography) Over Time up to Week 48 in the Study Eye | Week 4 | -79.19 μm | Standard Deviation 79.874 |
| RTH258/Brolucizumab | Change From Baseline in CFST (Central Sub-Field Retinal Thickness) as Assessed by OCT (Optical Coherence Tomography) Over Time up to Week 48 in the Study Eye | Week 8 (n=227) | -88.08 μm | Standard Deviation 91.505 |
| RTH258/Brolucizumab | Change From Baseline in CFST (Central Sub-Field Retinal Thickness) as Assessed by OCT (Optical Coherence Tomography) Over Time up to Week 48 in the Study Eye | Week 16 (n=220) | -48.87 μm | Standard Deviation 84.345 |
| RTH258/Brolucizumab | Change From Baseline in CFST (Central Sub-Field Retinal Thickness) as Assessed by OCT (Optical Coherence Tomography) Over Time up to Week 48 in the Study Eye | Week 48 (n = 195) | -66.75 μm | Standard Deviation 101.496 |
Secondary
Distribution of the Last Interval With no Disease Activity up to Week 48 in the Study Eye
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.
Time frame: Intervals of 0,4,5,6,7,8,9,10,11,12,13,14,15,16,17 Weeks
Population: Full Analysis Set - The full analysis set (FAS) comprises all patients who received at least one IVT injection of study treatment without protocol deviation with impact
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RTH258/Brolucizumab | Distribution of the Last Interval With no Disease Activity up to Week 48 in the Study Eye | q0wk | 10 Participants |
| RTH258/Brolucizumab | Distribution of the Last Interval With no Disease Activity up to Week 48 in the Study Eye | q4wk | 24 Participants |
| RTH258/Brolucizumab | Distribution of the Last Interval With no Disease Activity up to Week 48 in the Study Eye | q5wk | 13 Participants |
| RTH258/Brolucizumab | Distribution of the Last Interval With no Disease Activity up to Week 48 in the Study Eye | q6wk | 7 Participants |
| RTH258/Brolucizumab | Distribution of the Last Interval With no Disease Activity up to Week 48 in the Study Eye | q7wk | 19 Participants |
| RTH258/Brolucizumab | Distribution of the Last Interval With no Disease Activity up to Week 48 in the Study Eye | q8wk | 102 Participants |
| RTH258/Brolucizumab | Distribution of the Last Interval With no Disease Activity up to Week 48 in the Study Eye | q9wk | 28 Participants |
| RTH258/Brolucizumab | Distribution of the Last Interval With no Disease Activity up to Week 48 in the Study Eye | q10wk | 10 Participants |
| RTH258/Brolucizumab | Distribution of the Last Interval With no Disease Activity up to Week 48 in the Study Eye | q11wk | 13 Participants |
| RTH258/Brolucizumab | Distribution of the Last Interval With no Disease Activity up to Week 48 in the Study Eye | q12wk | 29 Participants |
| RTH258/Brolucizumab | Distribution of the Last Interval With no Disease Activity up to Week 48 in the Study Eye | q13wk | 10 Participants |
| RTH258/Brolucizumab | Distribution of the Last Interval With no Disease Activity up to Week 48 in the Study Eye | q14wk | 3 Participants |
| RTH258/Brolucizumab | Distribution of the Last Interval With no Disease Activity up to Week 48 in the Study Eye | q15wk | 4 Participants |
| RTH258/Brolucizumab | Distribution of the Last Interval With no Disease Activity up to Week 48 in the Study Eye | q16wk | 13 Participants |
| RTH258/Brolucizumab | Distribution of the Last Interval With no Disease Activity up to Week 48 in the Study Eye | q17wk | 4 Participants |
Secondary
Distribution of the Maximal Intervals With no Disease Activity up to Week 48 in the Study Eye
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.
Time frame: Intervals of 0,4,5,6,7,8,9,10,11,12,13,14,15,16,17 Weeks
Population: Full Analysis Set - The full analysis set (FAS) comprises all patients who received at least one IVT injection of study treatment without protocol deviation with impact
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RTH258/Brolucizumab | Distribution of the Maximal Intervals With no Disease Activity up to Week 48 in the Study Eye | q0wk | 10 Participants |
| RTH258/Brolucizumab | Distribution of the Maximal Intervals With no Disease Activity up to Week 48 in the Study Eye | q4wk | 19 Participants |
| RTH258/Brolucizumab | Distribution of the Maximal Intervals With no Disease Activity up to Week 48 in the Study Eye | q5wk | 18 Participants |
| RTH258/Brolucizumab | Distribution of the Maximal Intervals With no Disease Activity up to Week 48 in the Study Eye | q6wk | 3 Participants |
| RTH258/Brolucizumab | Distribution of the Maximal Intervals With no Disease Activity up to Week 48 in the Study Eye | q7wk | 6 Participants |
| RTH258/Brolucizumab | Distribution of the Maximal Intervals With no Disease Activity up to Week 48 in the Study Eye | q8wk | 51 Participants |
| RTH258/Brolucizumab | Distribution of the Maximal Intervals With no Disease Activity up to Week 48 in the Study Eye | q9wk | 48 Participants |
| RTH258/Brolucizumab | Distribution of the Maximal Intervals With no Disease Activity up to Week 48 in the Study Eye | q10wk | 19 Participants |
| RTH258/Brolucizumab | Distribution of the Maximal Intervals With no Disease Activity up to Week 48 in the Study Eye | q11wk | 14 Participants |
| RTH258/Brolucizumab | Distribution of the Maximal Intervals With no Disease Activity up to Week 48 in the Study Eye | q12wk | 56 Participants |
| RTH258/Brolucizumab | Distribution of the Maximal Intervals With no Disease Activity up to Week 48 in the Study Eye | q13wk | 16 Participants |
| RTH258/Brolucizumab | Distribution of the Maximal Intervals With no Disease Activity up to Week 48 in the Study Eye | q14wk | 3 Participants |
| RTH258/Brolucizumab | Distribution of the Maximal Intervals With no Disease Activity up to Week 48 in the Study Eye | q15wk | 5 Participants |
| RTH258/Brolucizumab | Distribution of the Maximal Intervals With no Disease Activity up to Week 48 in the Study Eye | q16wk | 16 Participants |
| RTH258/Brolucizumab | Distribution of the Maximal Intervals With no Disease Activity up to Week 48 in the Study Eye | q17wk | 4 Participants |
| RTH258/Brolucizumab | Distribution of the Maximal Intervals With no Disease Activity up to Week 48 in the Study Eye | q20wk | 1 Participants |
Secondary
Number of Patients With a Dry Retina (Neither IRF Nor SRF) up to Week 48 in the Study Eye
Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center.
Time frame: Baseline, Weeks 4, 8, 16, 48
Population: Full Analysis Set - The full analysis set (FAS) comprises all patients who received at least one IVT injection of study treatment without protocol deviation with impact.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RTH258/Brolucizumab | Number of Patients With a Dry Retina (Neither IRF Nor SRF) up to Week 48 in the Study Eye | Baseline | 4 Participants |
| RTH258/Brolucizumab | Number of Patients With a Dry Retina (Neither IRF Nor SRF) up to Week 48 in the Study Eye | Week 4 (n=260) | 114 Participants |
| RTH258/Brolucizumab | Number of Patients With a Dry Retina (Neither IRF Nor SRF) up to Week 48 in the Study Eye | Week 8 (n=229) | 122 Participants |
| RTH258/Brolucizumab | Number of Patients With a Dry Retina (Neither IRF Nor SRF) up to Week 48 in the Study Eye | Week 16 (n=222) | 69 Participants |
| RTH258/Brolucizumab | Number of Patients With a Dry Retina (Neither IRF Nor SRF) up to Week 48 in the Study Eye | Week 48 (n=198) | 80 Participants |
Secondary
Number of Patients With no Disease Activity at Week 48 in the Study Eye
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.
Time frame: Week 48
Population: Full Analysis Set - The full analysis set (FAS) comprises all patients who received at least one IVT injection of study treatment without protocol deviation with impact and with an assessment of disease activity at Week 48.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RTH258/Brolucizumab | Number of Patients With no Disease Activity at Week 48 in the Study Eye | 102 Participants |
Secondary
Summary of Treatment-emergent Adverse Events - Overall
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study.
Time frame: Adverse events were reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum duration of 52 weeks.
Population: Safety Analysis Set (SAF) - Includes all patients who were randomized to treatment, which includes 6 patients who were randomized but not treated.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RTH258/Brolucizumab | Summary of Treatment-emergent Adverse Events - Overall | Any adverse event | 165 Participants |
| RTH258/Brolucizumab | Summary of Treatment-emergent Adverse Events - Overall | Any adverse event - Treatment-related | 34 Participants |
| RTH258/Brolucizumab | Summary of Treatment-emergent Adverse Events - Overall | Any adverse event - Procedure-related | 33 Participants |
| RTH258/Brolucizumab | Summary of Treatment-emergent Adverse Events - Overall | Serious adverse events | 28 Participants |
| RTH258/Brolucizumab | Summary of Treatment-emergent Adverse Events - Overall | Serious adverse events- Treatment-related | 14 Participants |
| RTH258/Brolucizumab | Summary of Treatment-emergent Adverse Events - Overall | Serious adverse events - Procedure-related | 4 Participants |
| RTH258/Brolucizumab | Summary of Treatment-emergent Adverse Events - Overall | Fatal SAEs | 2 Participants |
| RTH258/Brolucizumab | Summary of Treatment-emergent Adverse Events - Overall | Fatal SAEs - Treatment-related | 0 Participants |
| RTH258/Brolucizumab | Summary of Treatment-emergent Adverse Events - Overall | Fatal SAEs - Procedure-related | 0 Participants |
| RTH258/Brolucizumab | Summary of Treatment-emergent Adverse Events - Overall | AEs causing treatment discontinuation | 39 Participants |
| RTH258/Brolucizumab | Summary of Treatment-emergent Adverse Events - Overall | AEs causing treatment discontinuation - Treatment-related | 30 Participants |
| RTH258/Brolucizumab | Summary of Treatment-emergent Adverse Events - Overall | AEs causing treatment discontinuation - Procedure-related | 5 Participants |
| RTH258/Brolucizumab | Summary of Treatment-emergent Adverse Events - Overall | AEs leading to treatment interruption | 0 Participants |
Secondary
Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Non-ocular
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study.
Time frame: Adverse events were reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum duration of 52 weeks.
Population: Safety Analysis Set (SAF) - Includes all patients who were randomized to treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RTH258/Brolucizumab | Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Non-ocular | 90 Participants |
Secondary
Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye)
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study.
Time frame: Adverse events were reported from first dose of study treatment until Week 48, plus 30 days post treatment, up to a maximum duration of 52 weeks.
Population: Safety Analysis Set (SAF) - Includes all patients who were randomized to treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RTH258/Brolucizumab | Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye) | Infections and infestations-Herpes ophthalmic | 1 Participants |
| RTH258/Brolucizumab | Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye) | Injury, poisoning and procedural complications | 3 Participants |
| RTH258/Brolucizumab | Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye) | Injury, poisoning and procedural complications-Foreign body in eye | 1 Participants |
| RTH258/Brolucizumab | Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye) | Injury, poisoning and procedural complications-Procedural pain | 1 Participants |
| RTH258/Brolucizumab | Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye) | Injury, poisoning and procedural complications-Thermal burn | 1 Participants |
| RTH258/Brolucizumab | Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye) | Investigations | 7 Participants |
| RTH258/Brolucizumab | Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye) | Investigations-Intraocular pressure increased | 7 Participants |
| RTH258/Brolucizumab | Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye) | Number of patients with at least one AE | 100 Participants |
| RTH258/Brolucizumab | Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye) | Eye disorders | 92 Participants |
| RTH258/Brolucizumab | Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye) | Eye disorders-Vitreous floaters | 15 Participants |
| RTH258/Brolucizumab | Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye) | Eye disorders-Ocular hypertension | 11 Participants |
| RTH258/Brolucizumab | Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye) | Eye disorders-Vitreous detachment | 9 Participants |
| RTH258/Brolucizumab | Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye) | Eye disorders-Uveitis | 8 Participants |
| RTH258/Brolucizumab | Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye) | Eye disorders-Vitritis | 8 Participants |
| RTH258/Brolucizumab | Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye) | Eye disorders-Cataract | 5 Participants |
| RTH258/Brolucizumab | Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye) | Eye disorders-Iridocyclitis | 5 Participants |
| RTH258/Brolucizumab | Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye) | Eye disorders-Dry eye | 4 Participants |
| RTH258/Brolucizumab | Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye) | Eye disorders-Eye inflammation | 4 Participants |
| RTH258/Brolucizumab | Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye) | Eye disorders-Eye irritation | 4 Participants |
| RTH258/Brolucizumab | Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye) | Eye disorders-Eye pain | 4 Participants |
| RTH258/Brolucizumab | Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye) | Eye disorders-Posterior capsule opacification | 4 Participants |
| RTH258/Brolucizumab | Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye) | Eye disorders-Retinal hemorrhage | 4 Participants |
| RTH258/Brolucizumab | Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye) | Eye disorders-Vision blurred | 4 Participants |
| RTH258/Brolucizumab | Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye) | Eye disorders-Conjunctival hemorrhage | 2 Participants |
| RTH258/Brolucizumab | Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye) | Eye disorders-Ocular vasculitis | 2 Participants |
| RTH258/Brolucizumab | Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye) | Eye disorders-Retinal artery occlusion | 2 Participants |
| RTH258/Brolucizumab | Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye) | Eye disorders-Retinal occlusive vasculitis | 2 Participants |
| RTH258/Brolucizumab | Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye) | Eye disorders-Retinal pigment epithelial tear | 2 Participants |
| RTH258/Brolucizumab | Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye) | Eye disorders-Retinal tear | 2 Participants |
| RTH258/Brolucizumab | Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye) | Eye disorders-Retinal vasculitis | 2 Participants |
| RTH258/Brolucizumab | Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye) | Eye disorders-Visual acuity reduced | 2 Participants |
| RTH258/Brolucizumab | Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye) | Eye disorders-Anterior chamber cell | 1 Participants |
| RTH258/Brolucizumab | Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye) | Eye disorders-Cyclitis | 1 Participants |
| RTH258/Brolucizumab | Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye) | Eye disorders-Diplopia | 1 Participants |
| RTH258/Brolucizumab | Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye) | Eye disorders-Dyschromatopsia | 1 Participants |
| RTH258/Brolucizumab | Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye) | Eye disorders-Eye hematoma | 1 Participants |
| RTH258/Brolucizumab | Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye) | Eye disorders-Eye pruritus | 1 Participants |
| RTH258/Brolucizumab | Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye) | Eye disorders-Glaucoma | 1 Participants |
| RTH258/Brolucizumab | Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye) | Eye disorders-Keratitis | 1 Participants |
| RTH258/Brolucizumab | Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye) | Eye disorders-Lacrimation increased | 1 Participants |
| RTH258/Brolucizumab | Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye) | Eye disorders-Macular hole | 1 Participants |
| RTH258/Brolucizumab | Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye) | Eye disorders-Ocular hyperemia | 1 Participants |
| RTH258/Brolucizumab | Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye) | Eye disorders-Ocular ischemic syndrome | 1 Participants |
| RTH258/Brolucizumab | Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye) | Eye disorders-Retinal aneurysm | 1 Participants |
| RTH258/Brolucizumab | Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye) | Eye disorders-Retinal degeneration | 1 Participants |
| RTH258/Brolucizumab | Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye) | Eye disorders-Retinal detachment | 1 Participants |
| RTH258/Brolucizumab | Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye) | Eye disorders-Retinal drusen | 1 Participants |
| RTH258/Brolucizumab | Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye) | Eye disorders-Retinal perivascular sheathing | 1 Participants |
| RTH258/Brolucizumab | Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye) | Eye disorders-Serous retinal detachment | 1 Participants |
| RTH258/Brolucizumab | Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye) | Eye disorders-Swelling of eyelid | 1 Participants |
| RTH258/Brolucizumab | Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye) | Eye disorders-Visual field defect | 1 Participants |
| RTH258/Brolucizumab | Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye) | Eye disorders-Vitreous hemorrhage | 1 Participants |
| RTH258/Brolucizumab | Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye) | Eye disorders-Vitreous opacities | 1 Participants |
| RTH258/Brolucizumab | Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye) | Infections and infestations | 3 Participants |
| RTH258/Brolucizumab | Summary of Treatment-emergent Adverse Events Regardless of Study Treatment Relationship by Primary System Organ Class, Preferred Term, and Maximum Severity - Ocular (Study Eye) | Infections and infestations-Conjunctivitis | 2 Participants |
Post Hoc
All Collected Deaths
On-treatment - up to 52 weeks; Post-treatment - greater than 30 days after last treatment, up to a maximum timeframe of 81 days after treatment
Time frame: On-treatment - up to 52 weeks; Post-treatment - greater than 30 days after last treatment, up to 81 days post-treatment
Population: Safety Analysis Set (SAF) - Includes all patients who were randomized to treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RTH258/Brolucizumab | All Collected Deaths | On-Treatment Deaths | 0 Participants |
| RTH258/Brolucizumab | All Collected Deaths | Post-Treatment Deaths | 2 Participants |
| RTH258/Brolucizumab | All Collected Deaths | All Deaths | 2 Participants |