A Study to Compare the Efficacy and Safety of Intravitrea... | NCT03525613 | Trialant
NCT03525613
Sponsor
Apellis Pharmaceuticals, Inc.
Status
Completed
Last Update Posted
Jul 6, 2023Actual
Enrollment
637Actual
Phase
Phase 3
Conditions
Geographic Atrophy
Interventions
APL-2
APL-2
Sham Procedure
Sham Procedure
Countries
United States
Australia
Brazil
Canada
Czechia
France
Germany
Israel
Italy
Netherlands
New Zealand
Poland
Spain
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT03525613
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
APL2-304
Secondary IDs
Not provided
Brief Title
A Study to Compare the Efficacy and Safety of Intravitreal APL-2 Therapy With Sham Injections in Patients With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration
Official Title
A Phase 3, Multi-Center, Randomized, Double-Masked, Sham-Controlled Study to Compare the Efficacy and Safety of Intravitreal Pegcetacoplan Therapy With Sham Injections in Patients With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)
Acronym
Not provided
Organization
Apellis Pharmaceuticals, Inc.INDUSTRY
Status Module
Record Verification Date
Jun 2023
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
Not provided
Start Date
Aug 31, 2018Actual
Primary Completion Date
Jun 28, 2021Actual
Completion Date
Jun 28, 2022Actual
First Submitted Date
Apr 20, 2018
First Submission Date that Met QC Criteria
May 3, 2018
First Posted Date
May 15, 2018Actual
Results Waived
Not provided
Results First Submitted Date
May 15, 2023
Results First Submitted that Met QC Criteria
Jun 29, 2023
Results First Posted Date
Jul 6, 2023Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Jun 20, 2022
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Jul 6, 2023Actual
Last Update Submitted Date
Jun 29, 2023
Last Update Posted Date
Jul 6, 2023Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Apellis Pharmaceuticals, Inc.INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is a 24-month, Phase III, multicenter, randomized, double-masked, sham-injection controlled study to assess the efficacy and safety of multiple IVT injections of APL-2 in subjects with GA secondary to AMD.
Detailed Description
Not provided
Conditions Module
Conditions
Geographic Atrophy
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
637Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
APL-2 15mg 0.1 mL Monthly for 24 months
Experimental
A single dose of 15 mg APL-2/0.1 mL will be administered via intravitreal injection in this study. Subjects will receive an injection every month
Drug: APL-2
APL-2 15mg 0.1 mL EOM for 24 months
Experimental
A single dose of 15 mg APL-2/0.1 mL will be administered via intravitreal injection in this study. Subjects will receive an injection every other month
Drug: APL-2
Sham Procedure Monthly for 24 months
Experimental
Sham Procedure monthly for 24 months
Other: Sham Procedure
Sham Procedure Every Other Month for 24 months
Experimental
Sham Procedure every other month for 24 months
Other: Sham Procedure
Interventions
Name
Type
Description
Arm Group Labels
Other Names
APL-2
Drug
Complement (C3) Inhibitor
APL-2 15mg 0.1 mL Monthly for 24 months
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Least Squares (LS) Mean Change From Baseline in Total Area of GA Lesions in the Study Eye at Month 12
The GA lesion area was measured by a quantified central reading center based on FAF images. LS mean was calculated using a mixed effect model for repeated measure (MMRM) model. Baseline was defined as the last available, non-missing observation prior to first study drug administration.
Baseline (screening) and Month 12
Secondary Outcomes
Measure
Description
Time Frame
LS Mean Change From Baseline in Total Area of GA Lesions in the Study Eye at Month 24
The GA lesion area was measured by a quantified central reading center based on FAF images. LS mean was calculated using a mixed effect model for repeated measure model. Baseline was defined as the last available, non-missing observation prior to first study drug administration.
Baseline (screening) and Month 24
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
The study eye must meet all inclusion criteria. If both eyes meet the inclusion criteria, the eye with the worst visual acuity at the screening visit will be designated as the study eye. If both eyes have the same visual acuity, the right eye will be selected as the study eye.
Ocular- specific inclusion criteria apply to the study eye only, unless otherwise specified.
Age ≥ 60 years.
Normal Luminance best corrected visual acuity of 24 letters or better using Early Treatment Diabetic Retinopathy Study (ETDRS) charts (approximately 20/320 Snellen equivalent).
Clinical diagnosis of GA of the macula secondary to AMD as determined by the Investigator and confirmed by the Reading Center.
The GA lesion must meet the following criteria as determined by the central reading center's assessment of Fundus Autofluorescence (FAF) imaging at screening:
Total GA area must be ≥ 2.5 and ≤ 17.5 mm2 (1 and 7 disk areas [DA] respectively)
If GA is multifocal, at least one focal lesion must be ≥ 1.25 mm2 (0.5 DA), with the overall aggregate area of GA, as specified above in 4a.
The entire GA lesion must be completely visualized on the macula centered image and must be able to be imaged in its entirety and not contiguous with any areas of peripapillary atrophy.
Presence of any pattern of hyperautofluorescence in the junctional zone of GA. Absence of hyperautofluorescence (i.e. pattern = none) is exclusionary.
Adequate clarity of ocular media, adequate pupillary dilation, and fixation to permit the collection of good quality images as determined by the Investigator.
Meets the following criteria related to microperimetry:
Able to detect fixation target.
Total elapsed time to complete the 10-2 68 point exam is ≤ 30 minutes in duration.
Reliability test ratio must be ≤ 20%.
Subject is willing and able to undertake microperimetry assessment in the opinion of the investigator.
Female subjects must be:
Women of non-child-bearing potential (WONCBP), or
Women of child-bearing potential (WOCBP) with a negative pregnancy test at screening and must agree to use protocol defined methods of contraception for the duration of the study and refrain from breastfeeding for the duration of the study.
Males with female partners of child-bearing potential must agree to use protocol defined methods of contraception and agree to refrain from donating sperm for the duration of the study.
Willing and able to give informed consent and to comply with the study procedures and assessments.
Exclusion Criteria:
Ocular specific exclusion criteria apply to the study eye only, unless otherwise specified.
GA secondary to a condition other than AMD such as Stargardt disease, cone rod dystrophy or toxic maculopathies like plaquenil maculopathy in either eye.
Spherical equivalent of the refractive error demonstrating > 6 diopters of myopia or an axial length >26 mm.
Any history or active choroidal neovascularization (CNV), associated with AMD or any other cause, including any evidence of retinal pigment epithelium rips or evidence of neovascularization anywhere based on SD-OCT imaging and/or fluorescein angiography as assessed by the Reading Center.
Presence of an active ocular disease that in the opinion of the Investigator compromises or confounds visual function, including but not limited to, uveitis, other macular diseases (e.g. clinically significant epiretinal membrane (ERM), full thickness macular hole or uncontrolled glaucoma/ocular hypertension. Benign conditions in the opinion of the investigator such as peripheral retina dystrophy are not exclusionary).
Intraocular surgery (including lens replacement surgery) within 3 months prior to randomization.
History of laser therapy in the macular region.
Aphakia or absence of the posterior capsule. Note: YAG laser posterior capsulotomy for posterior capsule opacification done at least 60 days prior to screening is not exclusionary.
Any ocular condition other than GA secondary to AMD that may require surgery or medical intervention during the study period or, in the opinion of the Investigator, could compromise visual function during the study period.
Any contraindication to IVT injection including current ocular or periocular infection.
History of prior intravitreal injection.
Unable to perform microperimetry reliably in the opinion of the investigator
Prior participation in another interventional clinical study for intravitreal therapies in either eye (including subjects receiving sham).
Prior participation in another interventional clinical study for geographic atrophy in either eye including investigational oral medication and placebo.
Participation in any systemic experimental treatment or any other systemic investigational new drug within 6 weeks or 5 half-lives of the active ingredient (whichever is longer) prior to the start of study treatment. Note: clinical trials solely involving observation, over-the-counter vitamins, supplements, or diets are not exclusionary.
Medical or psychiatric conditions that, in the opinion of the investigator, make consistent follow-up over the 24-month treatment period unlikely, or would make the subject an unsafe study candidate.
Any screening laboratory value (hematology, serum chemistry or urinalysis) that in the opinion of the Investigator is clinically significant and not suitable for study participation.
Known hypersensitivity to fluorescein sodium for injection or hypersensitivity to APL-2 or any of the excipients in APL-2 solution.
Sadda S, Hatcher KA, Shah BK, Kondapalli SS, Li C, Baumal CR. Outer Retinal Tubulation and Geographic Atrophy: A Natural History Analysis of Sham Observed Eyes from the OAKS and DERBY Trials. Ophthalmol Ther. 2025 Jul;14(7):1611-1619. doi: 10.1007/s40123-025-01156-5. Epub 2025 May 19.
Fu DJ, Bagga P, Naik G, Glinton S, Faes L, Liefers B, Lima R, Wignall G, Keane PA, Ioannidou E, Ribeiro Reis AP, McKeown A, Scheibler L, Patel PJ, Moghul I, Pontikos N, Balaskas K. Pegcetacoplan Treatment and Consensus Features of Geographic Atrophy Over 24 Months. JAMA Ophthalmol. 2024 Jun 1;142(6):548-558. doi: 10.1001/jamaophthalmol.2024.1269.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
This study consisted of a screening period (up to 30 days), a randomization visit on Day 1, and a treatment period (up to 24 months). Subjects were randomized in a 2:2:1:1 ratio on Day 1 to receive treatment with pegcetacoplan monthly, pegcetacoplan every other month (EOM), sham injection monthly or sham injection EOM, respectively. A total of 637 subjects were enrolled in this study.
Recruitment Details
This Phase III, randomized, double-masked, sham injection-controlled study was conducted in subjects with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) at 110 sites in 13 countries between 31 Aug 2018 and 28 Jun 2022.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Pegcetacoplan Monthly
Subjects received intravitreal (IVT) injections of pegcetacoplan 15 milligram (mg)/0.1 milliliter (mL) once monthly for 24 months.
Subjects will receive a Sham procedure every month
Sham Procedure Monthly for 24 months
Sham Procedure
Other
Subjects will receive a Sham procedure every other month
Sham Procedure Every Other Month for 24 months
Mean Change in Total Area of GA Lesions in the Study Eye Through Month 24
The mean change in GA lesion area through Month 24 was measured by assuming a piecewise linear trend in time with knots by FAF images at Months 6, 12, 18, and 24 and was calculated using a MMRM model. Baseline was defined as the last available, non-missing observation prior to first study drug administration.
From Baseline (screening) through Month 24
LS Mean Change From Baseline in Mean Threshold Sensitivity of All Points of the Study Eye at Month 24
Mean threshold sensitivity of all points was determined from the mesopic microperimetry as an assessment of the macular functional response. Microperimetry offers the option to test retinal light sensitivity while directly observing the fundus and allows for monitoring of macular function loss associated with GA progression. The microperimetry reading center overlaid the baseline FAF images with GA lesions traced by the imaging reading center and the corresponding macular integrity assessment microperimetry baseline scanning laser ophthalmoscope image and identified perilesional (within 500 microns outside the atrophy border), paralesional (beyond 500 microns outside the atrophy border), and extralesional (outside the atrophy border) loci on the microperimetry grid to determine the mean threshold sensitivity for these 3 areas. LS mean was calculated using a MMRM model. Baseline was defined as the last available, non-missing observation prior to first study drug administration.
Baseline (screening) and Month 24
LS Mean Change From Baseline in Monocular Maximum Reading Speed of the Study Eye at Month 24
The maximum reading speed of the study eye was calculated per Minnesota Low-Vision Reading Test (MNREAD) or Radner Reading Charts user manuals, with no adjustment for reading inaccuracy. An additional step to cap resulting reading speed values at a maximum of 300 words per minute (wpm) was implemented. Maximum reading speed was calculated as the mean of the 3 highest non-zero reading speeds (or 2, or 1 value, as available), except when all wpm were calculated as 0 then the maximum reading speed was calculated as 0. LS mean was calculated using a MMRM model. Baseline was defined as the last available, non-missing observation prior to first study drug administration.
Baseline (screening) and Month 24
LS Mean Change From Baseline in Mean Functional Reading Independence (FRI) Index Score at Month 24
The FRI was an interviewer-administered questionnaire with 7 items on functional reading activities most relevant to GA AMD subjects. It had 1 total index score. For each FRI Index reading activity performed in the past 7 days, subjects were asked about the extent to which they required assistance beyond eyeglasses/contact lenses, including the use of low-vision aids, adjustments in the activity, or help from another subject. Mean FRI Index scores ranged from 1 (unable to do independently) to 4 (totally independent), with higher scores indicating higher functional reading independence. A negative change from baseline indicated a decrease in the FRI; disease worsening. LS mean was calculated using a MMRM model. Baseline was defined as the last available, non-missing observation prior to first study drug administration.
Baseline (screening) and Month 24
LS Mean Change From Baseline in Normal-Luminance Best-Corrected Visual Acuity (NL-BCVA) Score of the Study Eye at Month 24
The NL-BCVA was assessed by early treatment diabetic retinopathy study (ETDRS) chart prior to dilating the eyes at a starting distance of 4 meters and ranged from 0 (least score) to 100 (best score). If the 4-meter score was >19 letters read correctly, the visual acuity score was the sum of total letters correctly read at 4 meters plus the addition of 30. If the 4-meter score was ≤19 letters read correctly, the visual acuity score was the sum of total letters read correctly at 4 meters and total letters read correctly at the 1-meter distance. If no letters were read correctly at either the 4-meter distance or the 1-meter distance, the visual acuity score was 0. A positive change in the value indicated improvement in visual acuity. LS mean was calculated using a MMRM model. Baseline was defined as the last available, non-missing observation prior to first study drug administration.
Baseline (screening) and Month 24
Bakersfield
California
93309
United States
Retina Vitreous Associates Medical Group
Beverly Hills
California
90211
United States
Retinal Diagnostic Center
Campbell
California
95508
United States
Retina Consultants of Orange County
Fullerton
California
92835
United States
Atlantis Eyecare
Huntington Beach
California
92647
United States
University of California, San Diego, Jacobs Retina
La Jolla
California
92093
United States
Byers Eye Institute at Stanford, Stanford School of Medicine
Palo Alto
California
94303
United States
Doheny Eye Center UCLA
Pasadena
California
91105
United States
Retina Consultants San Diego
Poway
California
92064
United States
Retinal Consultants Med Group, Inc.
Sacramento
California
95819
United States
Orange County Retina Medical Group
Santa Ana
California
92705
United States
California Retina Consultants
Santa Barbara
California
93103
United States
Southwest Retina Research Center, LLC
Durango
Colorado
81301
United States
Colorado Retina Associates
Golden
Colorado
80401
United States
Retina Group of New England
Waterford
Connecticut
06385
United States
Blue Ocean Clinical Research / The Macula Center
Clearwater
Florida
33761
United States
National Ophthalmic Research Institute (Retina Consultants of Southwest Florida)
Fort Myers
Florida
33912
United States
Bascom Palmer Eye Institute
Miami
Florida
33136
United States
Bascom Palmer Eye Institute of Naples
Naples
Florida
34103
United States
Retina Specialty Institute
Pensacola
Florida
32503
United States
Center for Retina and Macular Disease
Winter Haven
Florida
33880
United States
Southeast Retina Center, PC
Augusta
Georgia
30909
United States
Gailey Eye Clinic Retina Center
Bloomington
Illinois
61704
United States
Northwestern Feinberg School of Medicine
Chicago
Illinois
60611
United States
Rush University Medical Center
Chicago
Illinois
60612
United States
Midwest Eye Institute
Indianapolis
Indiana
46290
United States
Retina and Vitreous Associates of Kentucky, PSC dba Retina Associates of Kentucky
Tzoumas N, Riding G, Williams MA, Steel DH. Complement inhibitors for age-related macular degeneration. Cochrane Database Syst Rev. 2023 Jun 14;6(6):CD009300. doi: 10.1002/14651858.CD009300.pub3.
Subjects received IVT injections of pegcetacoplan 15 mg/0.1 mL EOM for 24 months.
FG002
Sham Monthly
Subjects received sham injections once monthly for 24 months. The procedure for sham injection was the same as that used for IVT injection until the actual injection but no actual injection occurred.
FG003
Sham EOM
Subjects received sham injections EOM for 24 months. The procedure for sham injection was the same as that used for IVT injection until the actual injection but no actual injection occurred.
FG000213 subjects
FG001212 subjects
FG002106 subjects
FG003106 subjects
COMPLETED
FG000144 subjects
FG001169 subjects
FG00276 subjects
FG00382 subjects
NOT COMPLETED
FG00069 subjects
FG00143 subjects
FG00230 subjects
FG00324 subjects
Type
Comment
Reasons
Adverse Event
FG00011 subjects
FG0018 subjects
FG0023 subjects
FG0033 subjects
Lost to Follow-up
FG0004 subjects
FG0015 subjects
FG0023 subjects
FG0032 subjects
Physician Decision
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
Consent Withdrawal
FG00025 subjects
FG00116 subjects
FG00212 subjects
FG0039 subjects
Death
FG00020 subjects
FG0019 subjects
FG0027 subjects
FG0031 subjects
Due to Coronavirus Disease-2019 (COVID-19) impact
FG0009 subjects
FG0014 subjects
FG0025 subjects
FG0038 subjects
The intent-to-treat (ITT) analysis set included all subjects assigned to treatment.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Pegcetacoplan Monthly
Subjects received IVT injections of pegcetacoplan 15 mg/0.1 mL once monthly for 24 months.
BG001
Pegcetacoplan EOM
Subjects received IVT injections of pegcetacoplan 15 mg/0.1 mL EOM for 24 months.
BG002
Sham Pooled
Sham Monthly: Subjects received sham injections once monthly for 24 months.
Sham EOM: Subjects received sham injections EOM for 24 months.
The procedure for sham injection was the same as that used for IVT injection until the actual injection but no actual injection occurred.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000213
BG001212
BG002212
BG003637
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00079.0± 7.21
BG00178.1± 7.81
BG00278.6± 7.20
BG003
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG000134
BG001122
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
No
Title
Denominators
Categories
White
Title
Measurements
BG000193
BG001196
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
No
Title
Denominators
Categories
Hispanic or Latino
Title
Measurements
BG0005
BG0017
BG002
Region of Enrollment
Count of Participants
Participants
No
Title
Denominators
Categories
United States
Title
Measurements
BG000152
BG001148
BG002
GA Lesion Size [fundus autofluorescence (FAF)] in the Study Eye
Mean
Standard Deviation
millimeter square (mm^2)
Title
Denominators
Categories
Title
Measurements
BG0008.2150± 3.91483
BG0018.3452± 3.95679
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Least Squares (LS) Mean Change From Baseline in Total Area of GA Lesions in the Study Eye at Month 12
The GA lesion area was measured by a quantified central reading center based on FAF images. LS mean was calculated using a mixed effect model for repeated measure (MMRM) model. Baseline was defined as the last available, non-missing observation prior to first study drug administration.
The modified intent-to-treat (mITT) analysis set included all subjects assigned to treatment who received at least 1 injection of pegcetacoplan or sham and had baseline and at least 1 post-baseline value of GA lesion area in the study eye as assessed by FAF. Subjects with a baseline and at least 1 post-baseline value of the outcome at a scheduled visit by Month 12 were included in the analysis.
Posted
Least Squares Mean
Standard Error
mm^2
Baseline (screening) and Month 12
ID
Title
Description
OG000
Pegcetacoplan Monthly
Subjects received IVT injections of pegcetacoplan 15 mg/0.1 mL once monthly for 24 months.
OG001
Pegcetacoplan EOM
Subjects received IVT injections of pegcetacoplan 15 mg/0.1 mL EOM for 24 months.
OG002
Sham Pooled
Sham Monthly: Subjects received sham injections once monthly for 24 months.
Sham EOM: Subjects received sham injections EOM for 24 months.
The procedure for sham injection was the same as that used for IVT injection until the actual injection but no actual injection occurred.
Units
Counts
Participants
OG000202
OG001204
OG002205
Title
Denominators
Categories
Title
Measurements
OG0001.5579± 0.08350
OG0011.6512± 0.08118
OG0021.9692± 0.08218
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Model included treatment + baseline GA lesion area (<7.5 mm^2 or ≥7.5 mm^2) + analysis visit + presence of choroidal neovascularization (CNV) in the fellow eye (yes or no) + analysis visit × treatment + baseline GA lesion area × analysis visit.
MMRM model
0.0004
LS Mean Difference
-0.4114
2-Sided
95
-0.6397
-0.1831
Superiority
OG001
Secondary
LS Mean Change From Baseline in Total Area of GA Lesions in the Study Eye at Month 24
The GA lesion area was measured by a quantified central reading center based on FAF images. LS mean was calculated using a mixed effect model for repeated measure model. Baseline was defined as the last available, non-missing observation prior to first study drug administration.
The mITT analysis set included all subjects assigned to treatment who received at least 1 injection of pegcetacoplan or sham and had baseline and at least 1 post-baseline value of GA lesion area in the study eye as assessed by FAF. Subjects with a baseline and at least 1 post-baseline value of the outcome at a scheduled visit by Month 24 were included in the analysis.
Posted
Least Squares Mean
Standard Error
mm^2
Baseline (screening) and Month 24
ID
Title
Description
OG000
Pegcetacoplan Monthly
Subjects received IVT injections of pegcetacoplan 15 mg/0.1 mL once monthly for 24 months.
OG001
Pegcetacoplan EOM
Subjects received IVT injections of pegcetacoplan 15 mg/0.1 mL EOM for 24 months.
OG002
Sham Pooled
Sham Monthly: Subjects received sham injections once monthly for 24 months.
Sham EOM: Subjects received sham injections EOM for 24 months.
The procedure for sham injection was the same as that used for IVT injection until the actual injection but no actual injection occurred.
Secondary
Mean Change in Total Area of GA Lesions in the Study Eye Through Month 24
The mean change in GA lesion area through Month 24 was measured by assuming a piecewise linear trend in time with knots by FAF images at Months 6, 12, 18, and 24 and was calculated using a MMRM model. Baseline was defined as the last available, non-missing observation prior to first study drug administration.
The mITT analysis set included all subjects assigned to treatment who received at least 1 injection of pegcetacoplan or sham and had baseline and at least 1 post-baseline value of GA lesion area in the study eye as assessed by FAF.
Posted
Mean
Standard Error
mm^2
From Baseline (screening) through Month 24
ID
Title
Description
OG000
Pegcetacoplan Monthly
Subjects received IVT injections of pegcetacoplan 15 mg/0.1 mL once monthly for 24 months.
OG001
Pegcetacoplan EOM
Subjects received IVT injections of pegcetacoplan 15 mg/0.1 mL EOM for 24 months.
OG002
Sham Pooled
Sham Monthly: Subjects received sham injections once monthly for 24 months.
Sham EOM: Subjects received sham injections EOM for 24 months.
The procedure for sham injection was the same as that used for IVT injection until the actual injection but no actual injection occurred.
Secondary
LS Mean Change From Baseline in Mean Threshold Sensitivity of All Points of the Study Eye at Month 24
Mean threshold sensitivity of all points was determined from the mesopic microperimetry as an assessment of the macular functional response. Microperimetry offers the option to test retinal light sensitivity while directly observing the fundus and allows for monitoring of macular function loss associated with GA progression. The microperimetry reading center overlaid the baseline FAF images with GA lesions traced by the imaging reading center and the corresponding macular integrity assessment microperimetry baseline scanning laser ophthalmoscope image and identified perilesional (within 500 microns outside the atrophy border), paralesional (beyond 500 microns outside the atrophy border), and extralesional (outside the atrophy border) loci on the microperimetry grid to determine the mean threshold sensitivity for these 3 areas. LS mean was calculated using a MMRM model. Baseline was defined as the last available, non-missing observation prior to first study drug administration.
The mITT analysis set included all subjects assigned to treatment who received at least 1 injection of pegcetacoplan or sham and had baseline and at least 1 post-baseline value of GA lesion area in the study eye as assessed by FAF. Subjects with a baseline and at least 1 post-baseline value of the outcome at a scheduled visit by Month 24 were included in the analysis.
Posted
Least Squares Mean
Standard Error
decibels (dB)
Baseline (screening) and Month 24
ID
Title
Description
OG000
Pegcetacoplan Monthly
Subjects received IVT injections of pegcetacoplan 15 mg/0.1 mL once monthly for 24 months.
Secondary
LS Mean Change From Baseline in Monocular Maximum Reading Speed of the Study Eye at Month 24
The maximum reading speed of the study eye was calculated per Minnesota Low-Vision Reading Test (MNREAD) or Radner Reading Charts user manuals, with no adjustment for reading inaccuracy. An additional step to cap resulting reading speed values at a maximum of 300 words per minute (wpm) was implemented. Maximum reading speed was calculated as the mean of the 3 highest non-zero reading speeds (or 2, or 1 value, as available), except when all wpm were calculated as 0 then the maximum reading speed was calculated as 0. LS mean was calculated using a MMRM model. Baseline was defined as the last available, non-missing observation prior to first study drug administration.
The mITT analysis set included all subjects assigned to treatment who received at least 1 injection of pegcetacoplan or sham and had baseline and at least 1 post-baseline value of GA lesion area in the study eye as assessed by FAF. Subjects with a baseline and at least 1 post-baseline value of the outcome at a scheduled visit by Month 24 were included in the analysis.
Posted
Least Squares Mean
Standard Error
wpm
Baseline (screening) and Month 24
ID
Title
Description
OG000
Pegcetacoplan Monthly
Subjects received IVT injections of pegcetacoplan 15 mg/0.1 mL once monthly for 24 months.
OG001
Pegcetacoplan EOM
Subjects received IVT injections of pegcetacoplan 15 mg/0.1 mL EOM for 24 months.
Secondary
LS Mean Change From Baseline in Mean Functional Reading Independence (FRI) Index Score at Month 24
The FRI was an interviewer-administered questionnaire with 7 items on functional reading activities most relevant to GA AMD subjects. It had 1 total index score. For each FRI Index reading activity performed in the past 7 days, subjects were asked about the extent to which they required assistance beyond eyeglasses/contact lenses, including the use of low-vision aids, adjustments in the activity, or help from another subject. Mean FRI Index scores ranged from 1 (unable to do independently) to 4 (totally independent), with higher scores indicating higher functional reading independence. A negative change from baseline indicated a decrease in the FRI; disease worsening. LS mean was calculated using a MMRM model. Baseline was defined as the last available, non-missing observation prior to first study drug administration.
The mITT analysis set included all subjects assigned to treatment who received at least 1 injection of pegcetacoplan or sham and had baseline and at least 1 post-baseline value of GA lesion area in the study eye as assessed by FAF. Subjects with a baseline and at least 1 post-baseline value of the outcome at a scheduled visit by Month 24 were included in the analysis.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline (screening) and Month 24
ID
Title
Description
OG000
Pegcetacoplan Monthly
Subjects received IVT injections of pegcetacoplan 15 mg/0.1 mL once monthly for 24 months.
OG001
Pegcetacoplan EOM
Secondary
LS Mean Change From Baseline in Normal-Luminance Best-Corrected Visual Acuity (NL-BCVA) Score of the Study Eye at Month 24
The NL-BCVA was assessed by early treatment diabetic retinopathy study (ETDRS) chart prior to dilating the eyes at a starting distance of 4 meters and ranged from 0 (least score) to 100 (best score). If the 4-meter score was >19 letters read correctly, the visual acuity score was the sum of total letters correctly read at 4 meters plus the addition of 30. If the 4-meter score was ≤19 letters read correctly, the visual acuity score was the sum of total letters read correctly at 4 meters and total letters read correctly at the 1-meter distance. If no letters were read correctly at either the 4-meter distance or the 1-meter distance, the visual acuity score was 0. A positive change in the value indicated improvement in visual acuity. LS mean was calculated using a MMRM model. Baseline was defined as the last available, non-missing observation prior to first study drug administration.
The mITT analysis set included all subjects assigned to treatment who received at least 1 injection of pegcetacoplan or sham and had baseline and at least 1 post-baseline value of GA lesion area in the study eye as assessed by FAF. Subjects with a baseline and at least 1 post-baseline value of the outcome at a scheduled visit by Month 24 were included in the analysis.
Posted
Least Squares Mean
Standard Error
ETDRS letters score
Baseline (screening) and Month 24
ID
Title
Description
OG000
Pegcetacoplan Monthly
Subjects received IVT injections of pegcetacoplan 15 mg/0.1 mL once monthly for 24 months.
Time Frame
Treatment-emergent adverse events (TEAEs) were reported from first study drug administration (Day 1) up to the last visit or early termination visit, 30 days after the last study drug administration for the monthly treatment groups and 60 days after the last study drug administration for the EOM treatment groups, a maximum of 24 months.
Description
The safety analysis set included all subjects randomly assigned to treatment who received at least 1 injection of pegcetacoplan or sham. Ocular TEAEs are presented separately for the study and fellow eyes, and non-ocular (systemic) TEAEs are also presented.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Pegcetacoplan Monthly: Ocular Study Eye
Ocular TEAEs were summarized for the study eye for all subjects who received IVT injections of pegcetacoplan 15 mg/0.1 mL once monthly for 24 months.
0
213
5
213
100
213
EG001
Pegcetacoplan EOM: Ocular Study Eye
Ocular TEAEs were summarized for the study eye for all subjects who received IVT injections of pegcetacoplan 15 mg/0.1 mL EOM for 24 months.
0
212
4
212
95
212
EG002
Sham Pooled: Ocular Study Eye
Ocular TEAEs were summarized for the study eye for all subjects who were randomized to sham monthly and sham EOM treatment groups.
Sham Monthly: Subjects received sham injections once monthly for 24 months.
Sham EOM: Subjects received sham injections EOM for 24 months.
The procedure for sham injection was the same as that used for IVT injection until the actual injection but no actual injection occurred.
0
211
1
211
59
211
EG003
Pegcetacoplan Monthly: Ocular Fellow Eye
Ocular TEAEs were summarized for the fellow eye for all subjects who received IVT injections of pegcetacoplan 15 mg/0.1 mL once monthly for 24 months.
0
213
1
213
69
213
EG004
Pegcetacoplan EOM: Ocular Fellow Eye
Ocular TEAEs were summarized for the fellow eye for all subjects who received IVT injections of pegcetacoplan 15 mg/0.1 mL EOM for 24 months.
0
212
0
212
56
212
EG005
Sham Pooled: Ocular Fellow Eye
Ocular TEAEs were summarized for the fellow eye for all subjects who were randomized to sham monthly and sham EOM treatment groups.
Sham Monthly: Subjects received sham injections once monthly for 24 months.
Sham EOM: Subjects received sham injections EOM for 24 months.
The procedure for sham injection was the same as that used for IVT injection until the actual injection but no actual injection occurred.
0
211
2
211
65
211
EG006
Pegcetacoplan Monthly: Non-ocular
Non-ocular (systemic) TEAEs were summarized for all subjects who received IVT injections of pegcetacoplan 15 mg/0.1 mL once monthly for 24 months.
20
213
77
213
86
213
EG007
Pegcetacoplan EOM: Non-ocular
Non-ocular (systemic) TEAEs were summarized for all subjects who received IVT injections of pegcetacoplan 15 mg/0.1 mL EOM for 24 months.
9
212
56
212
72
212
EG008
Sham Pooled: Non-ocular
Non-ocular (systemic) TEAEs were summarized for all subjects who were randomized to sham monthly and sham EOM treatment groups.
Sham Monthly: Subjects received sham injections once monthly for 24 months.
Sham EOM: Subjects received sham injections EOM for 24 months.
The procedure for sham injection was the same as that used for IVT injection until the actual injection but no actual injection occurred.
8
211
55
211
67
211
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Blood loss anaemia
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG0030 events0 affected213 at risk
EG0040 events0 affected212 at risk
EG0050 events0 affected211 at risk
EG0060 events0 affected213 at risk
EG0071 events1 affected212 at risk
EG0081 events1 affected211 at risk
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Splenic infarction
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Arrhythmia
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Cardiac failure acute
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Cardiogenic shock
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Coronary artery stenosis
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Mitral valve incompetence
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Sinus node dysfunction
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Supraventricular extrasystoles
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Coronary artery occlusion
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Right ventricular failure
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Vertigo positional
Ear and labyrinth disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Optic ischaemic neuropathy
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0002 events2 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Retinal detachment
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected213 at risk
EG0011 events1 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Papilloedema
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Visual acuity reduced
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0021 events1 affected211 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Colitis ulcerative
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Abdominal hernia
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Gastric ulcer
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Intestinal perforation
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Large intestine polyp
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Peptic ulcer haemorrhage
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Diverticular perforation
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Duodenal ulcer haemorrhage
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Hypoaesthesia oral
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Intestinal haemorrhage
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Intestinal ischaemia
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Death
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
General physical health deterioration
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Disease complication
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Multiple organ dysfunction syndrome
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Asthenia
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Chest discomfort
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Sudden death
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Cirrhosis alcoholic
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Hepatic failure
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Endophthalmitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0002 events2 affected213 at risk
EG0013 events3 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
COVID-19
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
COVID-19 pneumonia
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Septic shock
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Sepsis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Acute sinusitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Bronchiolitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Enterococcal bacteraemia
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Influenza
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Klebsiella bacteraemia
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Post procedural infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Postoperative wound infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Pyelonephritis acute
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Arthritis infective
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Blastocystis infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Bronchitis bacterial
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Localised infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Urosepsis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Hyphaema
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Anaemia postoperative
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Cervical vertebral fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Jaw fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Lower limb fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Meniscus injury
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Multiple injuries
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Pelvic fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Post procedural haematuria
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Postoperative thrombosis
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Sternal fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Subcutaneous haematoma
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Urinary retention postoperative
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Face injury
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Splenic rupture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Upper limb fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Hypernatraemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Rheumatoid arthritis
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Synovial cyst
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Acute myeloid leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Chronic myeloid leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Skin cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Anal squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Benign lung neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Colon cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Endometrial cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Fibrosarcoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Lung neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Malignant melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Non-small cell lung cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Ovarian cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Pancreatic carcinoma metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Urethral cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Adenocarcinoma of colon
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Brain cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Brain neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Lung adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Lung adenocarcinoma stage III
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Lung cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Metastases to thorax
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected213 at risk
EG0010 events0 affected212 at risk
EG0020 events0 affected211 at risk
EG003
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Model included treatment + baseline GA lesion area (<7.5 mm^2 or ≥7.5 mm^2) + analysis visit + presence of CNV in the fellow eye (yes or no) + analysis visit × treatment + baseline GA lesion area × analysis visit.
MMRM model
0.0055
LS Mean Difference
-0.3180
2-Sided
95
-0.5423
-0.0937
Superiority
Units
Counts
Participants
OG000202
OG001204
OG002206
Title
Denominators
Categories
Title
Measurements
OG0003.1237± 0.14327
OG0013.2826± 0.13238
OG0024.0252± 0.14642
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Model included treatment + baseline GA lesion area (<7.5 mm^2 or ≥7.5 mm^2) + analysis visit + baseline presence of CNV in the fellow eye (yes or no) + analysis visit × treatment + baseline GA lesion area (<7.5 mm^2 or ≥7.5 mm^2) × analysis visit.
MMRM model
<0.0001
LS Mean Difference
-0.9015
2-Sided
95
-1.3026
-0.5004
Superiority
OG001
OG002
Model included treatment + baseline GA lesion area (<7.5 mm^2 or ≥7.5 mm^2) + analysis visit + baseline presence of CNV in the fellow eye (yes or no) + analysis visit × treatment + baseline GA lesion area (<7.5 mm^2 or ≥7.5 mm^2) × analysis visit.
MMRM model
0.0002
LS Mean Difference
-0.7426
2-Sided
95
-1.1282
-0.3570
Superiority
Units
Counts
Participants
OG000202
OG001205
OG002207
Title
Denominators
Categories
From Baseline to Month 6
Title
Measurements
OG0000.7604± 0.04629
OG0010.8220± 0.04346
OG0020.9838± 0.04666
From Month 6 to Month 12
Title
Measurements
OG0000.7848± 0.05958
OG0010.8184± 0.05660
OG0020.9710± 0.05163
From Month 12 to Month 18
Title
Measurements
OG0000.8004± 0.05034
OG0010.8682± 0.04959
OG0021.0269± 0.05288
From Month 18 to Month 24
Title
Measurements
OG0000.7617± 0.6650
OG0010.7499± 0.04372
OG0020.9958± 0.05824
From Baseline to Month 24
Title
Measurements
OG0003.1073± 0.14841
OG0013.2586± 0.13420
OG0023.9775± 0.14310
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Estimates for Baseline to Month 6: Model included Treatment + Baseline GA lesion area (< 7.5 mm^2 or >= 7.5 mm^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +
MMRM model
0.0007
Mean Difference
-0.2234
2-Sided
95
-0.3522
-0.0946
Superiority
Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.
OG001
OG002
Estimates for Baseline to Month 6: Model included Treatment + Baseline GA lesion area (< 7.5 mm^2 or >= 7.5 mm^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +
MMRM model
0.0116
Mean Difference
-0.1618
2-Sided
95
-0.2874
-0.0361
Superiority
Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.
OG000
OG002
Estimates for Month 6 to Month 12: Model included Treatment + Baseline GA lesion area (< 7.5 mm^2 or >= 7.5 mm^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +
MMRM model
0.0181
Mean Difference
-0.1862
2-Sided
95
-0.3406
-0.0318
Superiority
Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.
OG001
OG002
Estimates for Month 6 to Month 12: Model included Treatment + Baseline GA lesion area (< 7.5 mm^2 or >= 7.5 mm^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +
MMRM model
0.0467
Mean Difference
-0.1526
2-Sided
95
-0.3030
-0.0023
Superiority
Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.
OG000
OG002
Estimates for Month 12 to Month 18: Model included Treatment + Baseline GA lesion area (< 7.5 mm^2 or >= 7.5 mm^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +
MMRM model
0.0019
Mean Difference
-0.2265
2-Sided
95
-0.3696
-0.0834
Superiority
Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.
OG001
OG002
Estimates for Month 12 to Month 18: Model included Treatment + Baseline GA lesion area (< 7.5 mm^2 or >= 7.5 mm^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +
MMRM model
0.0288
Mean Difference
-0.1586
2-Sided
95
-0.3009
-0.0164
Superiority
Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.
OG000
OG002
Estimates for Month 18 to Month 24: Model included Treatment + Baseline GA lesion area (< 7.5 mm^2 or >= 7.5 mm^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +
MMRM model
0.0080
Mean Difference
-0.2341
2-Sided
95
-0.4071
-0.0611
Superiority
Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.
OG001
OG002
Estimates for Month 18 to Month 24: Model included Treatment + Baseline GA lesion area (< 7.5 mm^2 or >= 7.5 mm^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +
MMRM model
0.0007
Mean Difference
-0.2459
2-Sided
95
-0.3886
-0.1031
Superiority
Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.
OG000
OG002
Estimates for Baseline to Month 24: Model included Treatment + Baseline GA lesion area (< 7.5 mm^2 or >= 7.5 mm^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +
MMRM model
<0.0001
Mean Difference
-0.8702
2-Sided
95
-1.2740
-0.4664
Superiority
Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.
OG001
OG002
Estimates for Baseline to Month 24: Model included Treatment + Baseline GA lesion area (< 7.5 mm^2 or >= 7.5 mm^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +
MMRM model
0.0003
Mean Difference
-0.7189
2-Sided
95
-1.1039
-0.3339
Superiority
Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.
OG001
Pegcetacoplan EOM
Subjects received IVT injections of pegcetacoplan 15 mg/0.1 mL EOM for 24 months.
OG002
Sham Pooled
Sham Monthly: Subjects received sham injections once monthly for 24 months.
Sham EOM: Subjects received sham injections EOM for 24 months.
The procedure for sham injection was the same as that used for IVT injection until the actual injection but no actual injection occurred.
Units
Counts
Participants
OG000179
OG001187
OG002186
Title
Denominators
Categories
Title
Measurements
OG000-3.319± 0.2969
OG001-3.064± 0.2331
OG002-2.954± 0.2156
OG002
Sham Pooled
Sham Monthly: Subjects received sham injections once monthly for 24 months.
Sham EOM: Subjects received sham injections EOM for 24 months.
The procedure for sham injection was the same as that used for IVT injection until the actual injection but no actual injection occurred.
Units
Counts
Participants
OG000168
OG001181
OG002181
Title
Denominators
Categories
Title
Measurements
OG000-22.446± 3.0329
OG001-17.533± 3.2886
OG002-16.211± 3.8129
Subjects received IVT injections of pegcetacoplan 15 mg/0.1 mL EOM for 24 months.
OG002
Sham Pooled
Sham Monthly: Subjects received sham injections once monthly for 24 months.
Sham EOM: Subjects received sham injections EOM for 24 months.
The procedure for sham injection was the same as that used for IVT injection until the actual injection but no actual injection occurred.
Units
Counts
Participants
OG000185
OG001193
OG002195
Title
Denominators
Categories
Title
Measurements
OG000-0.287± 0.0563
OG001-0.379± 0.0536
OG002-0.273± 0.0554
OG001
Pegcetacoplan EOM
Subjects received IVT injections of pegcetacoplan 15 mg/0.1 mL EOM for 24 months.
OG002
Sham Pooled
Sham Monthly: Subjects received sham injections once monthly for 24 months.
Sham EOM: Subjects received sham injections EOM for 24 months.
The procedure for sham injection was the same as that used for IVT injection until the actual injection but no actual injection occurred.