Study to Compare the Efficacy and Safety of Intravitreal... | NCT03525600 | Trialant
NCT03525600
Sponsor
Apellis Pharmaceuticals, Inc.
Status
Completed
Last Update Posted
Jun 18, 2023Actual
Enrollment
621Actual
Phase
Phase 3
Conditions
Geographic Atrophy
Interventions
APL-2
APL-2
Sham Procedure
Sham Procedure
Countries
United States
Argentina
Australia
Brazil
Canada
Czechia
France
Germany
Israel
Italy
New Zealand
Poland
Puerto Rico
Spain
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT03525600
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
APL2-303
Secondary IDs
Not provided
Brief Title
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
May 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 21, 2021Actual
Completion Date
Jun 20, 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 24, 2023
Results First Submitted that Met QC Criteria
May 24, 2023
Results First Posted Date
Jun 18, 2023Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Jun 20, 2022
Certification/Extension First Submitted that Passed QC Review
Jun 20, 2022
Certification/Extension First Posted Date
Jun 22, 2022Actual
Last Update Submitted Date
May 24, 2023
Last Update Posted Date
Jun 18, 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
621Actual
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 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 the 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 MMRM 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.
Female subjects must be:
Women of non-child-bearing potential (WONCBP), or
Women of child-bearing potential (WOCBP) with a negative serum 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.
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.
Wykoff CC, Holz FG, Chiang A, Boyer D, Dhoot DS, Loewenstein A, Mones J, Heier J, Abbey AM, Singerman LJ, Vajzovic L, Lin J, Li C, Vilupuru A, Baumal CR; OAKS, DERBY, and GALE Investigators. Pegcetacoplan Treatment for Geographic Atrophy in Age-Related Macular Degeneration Over 36 Months: Data From OAKS, DERBY, and GALE. Am J Ophthalmol. 2025 Aug;276:350-364. doi: 10.1016/j.ajo.2025.04.016. Epub 2025 Apr 23.
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 621 subjects were randomized 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 122 sites in 14 countries between 31 Aug 2018 and 20 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, and 18 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 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
Phoenix
Arizona
85020
United States
Retina Institute of California dba Acuity Eye Grp
Arcadia
California
91007
United States
California Retina Consultants
Bakersfield
California
93309
United States
Retina Vitreous Associates Medical Group
Beverly Hills
California
90211
United States
The Retina Partners
Encino
California
91436
United States
The Gavin Herbert Eye Institute/UC Irvine
Irvine
California
92697
United States
Northern California Retina Vitreous Associates
Mountain View
California
94040
United States
Retina Institute of California Medical Group
Palm Desert
California
92260
United States
Byers Eye Institute at Standford, Stanford School of Medicine
Palo Alto
California
94303
United States
Retina Consultants San Diego
Poway
California
92064
United States
Retina Consultants of Southern California
Redlands
California
92374
United States
California Retina Consultants
Santa Barbara
California
93103
United States
Bay Area Retina Associates
Walnut Creek
California
94598
United States
Danbury Eye Physicians & Surgeons, P.C. - Danbury
Danbury
Connecticut
06810
United States
New England Retina Associates
Hamden
Connecticut
06518
United States
Retina Group of New England,PC
Waterford
Connecticut
06385
United States
Florida Eye Microsurgical Institute, Inc.
Boynton Beach
Florida
33426
United States
Pinnacle Research Institute
Fort Lauderdale
Florida
33309
United States
Retina Health Center
Fort Myers
Florida
33907
United States
Bascom Palmer Eye Institute
Palm Beach Gardens
Florida
33418
United States
Eye Associates of Pinellas
Pinellas Park
Florida
33782
United States
East Florida Eye Institute
Stuart
Florida
34994
United States
Southern Vitreoretinal Associates
Tallahassee
Florida
32308
United States
Retina Associates of Florida
Tampa
Florida
33609
United States
University of South Florida (USF) Eye Institute
Tampa
Florida
33612
United States
Southeast Retina Center, PC
Augusta
Georgia
30909
United States
Georgia Retina
Marietta
Georgia
30060
United States
Midwest Eye Institute
Indianapolis
Indiana
46290
United States
Sabates Eye Center
Leawood
Kansas
66211
United States
Elman Retina Group, PA
Baltimore
Maryland
21236
United States
Cumberland Valley Retina Consultants, PC
Hagerstown
Maryland
21740
United States
Mid Atlantic Retina Specialists
Hagerstown
Maryland
21740
United States
Retina Specialists
Towson
Maryland
21204
United States
Ophthalmic Consultants of Boston
Boston
Massachusetts
02114
United States
New England Retina Consultants, PC
Springfield
Massachusetts
01107
United States
Associated Retinal Consultants, P.C
Grand Rapids
Michigan
49546
United States
Retina Specialists of Michigan / Foundation for Vision
Grand Rapids
Michigan
49546
United States
Retina Consultants of Michigan
Southfield
Michigan
48034
United States
Associated Retinal Consultants PC
Traverse City
Michigan
49686
United States
Sierra Eye Associates
Reno
Nevada
89503
United States
Retina Associates of New Jersey (NJ Retina)
Teaneck
New Jersey
07666
United States
Long Island Vitreoretinal Consultants
Great Neck
New York
11021
United States
Vitreous Retina Macula Consultants of NY
New York
New York
10022
United States
Western Carolina Retinal Associates
Asheville
North Carolina
28803
United States
Charlotte Eye Ear Nose and Throat Associates, PS
Charlotte
North Carolina
28210
United States
Graystone Eye
Hickory
North Carolina
28602
United States
Retina Associates of Cleveland, Inc.
Cleveland
Ohio
44122
United States
Retina Associates of Cleveland, Inc
Cleveland
Ohio
44122
United States
Retina Associates of Cleveland
Cleveland
Ohio
44130
United States
Cleveland Clinic, Cole Eye Institute
Cleveland
Ohio
44195
United States
The Ohio State University
Columbus
Ohio
43212
United States
Retina Associates of Cleveland, Inc.
Youngstown
Ohio
44505
United States
Retina Northwest, PC
Portland
Oregon
97221
United States
Eye Health Northwest
Portland
Oregon
97225
United States
Mid Atlantic Retina
Philadelphia
Pennsylvania
19006
United States
Black Hills Regional Eye Institute
Rapid City
South Dakota
57701
United States
Tennessee Retina, PC
Nashville
Tennessee
37203
United States
Retina Research Institute of Texas
Abilene
Texas
79606
United States
Southwest Retina Specialists
Amarillo
Texas
79106
United States
Retina Consultants of Austin (Retina Research Center)
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.
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.
FG000206 subjects
FG001208 subjects
FG002102 subjects
FG003105 subjects
COMPLETED
FG000147 subjects
FG001161 subjects
FG00278 subjects
FG00383 subjects
NOT COMPLETED
FG00059 subjects
FG00147 subjects
FG00224 subjects
FG00322 subjects
Type
Comment
Reasons
Adverse Event
FG0009 subjects
FG0016 subjects
FG0025 subjects
FG0033 subjects
Lost to Follow-up
FG0002 subjects
FG0014 subjects
FG0024 subjects
FG0030 subjects
Physician Decision
FG0001 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
Consent withdrawal
FG00036 subjects
FG00120 subjects
FG0026 subjects
FG00313 subjects
Death
FG0007 subjects
FG0016 subjects
FG0024 subjects
FG0033 subjects
Due to Coronavirus Disease-2019 (COVID-19) impact
FG0004 subjects
FG00110 subjects
FG0023 subjects
FG0033 subjects
Other
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
The Intent-to-treat (ITT) analysis set consisted of 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
BG000206
BG001208
BG002207
BG003621
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
BG00078.8± 6.91
BG00179.2± 7.06
BG00278.5± 7.24
BG003
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG000121
BG001126
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
No
Title
Denominators
Categories
White
Title
Measurements
BG000192
BG001192
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
No
Title
Denominators
Categories
Hispanic or Latino
Title
Measurements
BG00032
BG00137
BG002
Region of Enrollment
Count of Participants
Participants
No
Title
Denominators
Categories
United States
Title
Measurements
BG000146
BG001126
BG002
GA Lesion Size (fundus autofluorescence [FAF]) in the Study Eye
Mean
Standard Deviation
Millimeter square (mm^2)
Title
Denominators
Categories
Title
Measurements
BG0008.3606± 4.16892
BG0018.2076± 3.91213
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 ITT (mITT) analysis set consisted of 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
OG000200
OG001199
OG002193
Title
Denominators
Categories
Title
Measurements
OG0001.7344± 0.07924
OG0011.7563± 0.07446
OG0021.9640± 0.09592
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
0.0615
LS Mean Difference
-0.2296
2-Sided
95
-0.4703
0.0111
Superiority
OG001
Secondary
LS Mean Change From Baseline in the 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 MMRM model. Baseline was defined as the last available, non-missing observation prior to first study drug administration.
The mITT analysis set consisted of 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, and 18 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 consisted of 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
Least Squares 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 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 consisted of 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 consisted of 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
scores 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 consisted of 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 letter 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 consisted of all randomized subjects 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
206
4
206
113
206
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
208
2
208
82
208
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
206
2
206
61
206
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
206
1
206
35
206
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
208
1
208
34
208
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
206
0
206
29
206
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.
8
206
61
206
90
206
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.
6
208
47
208
70
208
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
206
53
206
101
206
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Uveitis
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0012 events2 affected208 at risk
EG0020 events0 affected206 at risk
EG0030 events0 affected206 at risk
EG0040 events0 affected208 at risk
EG0050 events0 affected206 at risk
EG0060 events0 affected206 at risk
EG0070 events0 affected208 at risk
EG0080 events0 affected206 at risk
Vitritis
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0002 events2 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Iridocyclitis
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0011 events1 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Optic ischaemic neuropathy
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Retinal tear
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Visual acuity reduced
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0011 events1 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Dry age-related macular degeneration
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0021 events1 affected206 at risk
EG003
Macular hole
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0021 events1 affected206 at risk
EG003
Cataract
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Choroid melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Acute coronary syndrome
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Aortic valve stenosis
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Arrhythmia
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Atrioventricular block complete
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Cardiogenic shock
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Coronary artery stenosis
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Ischaemic cardiomyopathy
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Left ventricular failure
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Mitral valve incompetence
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Cardiac failure chronic
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Inappropriate antidiuretic hormone secretion
Endocrine disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Hiatus hernia
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Colitis microscopic
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Rectal prolapse
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Asthenia
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Fatigue
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Death
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Ill-defined disorder
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Influenza like illness
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Pyrexia
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
COVID-19
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Sepsis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Influenza
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Urosepsis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
COVID-19 pneumonia
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Infected skin ulcer
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Infective exacerbation of chronic obstructive airways disease
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Kidney infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Pathogen resistance
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Anaesthetic complication
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Back injury
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Cervical vertebral fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Femoral neck fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Joint injury
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Lower limb fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Procedural pneumothorax
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Radius fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Subdural haemorrhage
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Ulna fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Post procedural haemorrhage
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Spinal fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Breath sounds abnormal
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Electrolyte imbalance
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Fluid overload
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Fluid retention
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Dupuytren's contracture
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Lumbar spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Spondylolisthesis
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
B-cell lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Bladder cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Endometrial cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Hairy cell leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Laryngeal cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Laryngeal cancer recurrent
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Lip neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Lung adenocarcinoma stage II
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Lung adenocarcinoma stage III
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Plasma cell myeloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Squamous cell carcinoma of lung
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Squamous cell carcinoma of the oral cavity
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Superficial spreading melanoma stage III
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Acoustic neuroma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Adenocarcinoma of colon
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Bladder transitional cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Colon cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Lung carcinoma cell type unspecified stage I
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Lung neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Malignant melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected206 at risk
EG0010 events0 affected208 at risk
EG0020 events0 affected206 at risk
EG003
Neoplasm malignant
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
0.0854
LS Mean Difference
-0.2077
2-Sided
95
-0.4444
0.0290
Superiority
Units
Counts
Participants
OG000200
OG001200
OG002194
Title
Denominators
Categories
Title
Measurements
OG0003.2275± 0.12457
OG0013.3395± 0.13034
OG0023.9726± 0.16820
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
0.0004
LS Mean Difference
-0.7451
2-Sided
95
-1.1539
-0.3362
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
0.0030
LS Mean Difference
-0.6331
2-Sided
95
-1.0508
-0.2153
Superiority
Units
Counts
Participants
OG000201
OG001201
OG002195
Title
Denominators
Categories
From Baseline to Month 6
Title
Measurements
OG0000.9075± 0.04755
OG0010.8829± 0.04660
OG0020.9622± 0.04983
From Month 6 to Month 12
Title
Measurements
OG0000.8409± 0.05128
OG0010.8473± 0.05086
OG0021.0132± 0.05998
From Month 12 to Month 18
Title
Measurements
OG0000.9033± 0.04917
OG0010.8803± 0.05105
OG0021.0483± 0.05574
From Month 18 to Month 24
Title
Measurements
OG0000.6262± 0.06809
OG0010.6946± 0.05256
OG0020.9794± 0.05469
From Baseline to Month 24
Title
Measurements
OG0003.2780± 0.12525
OG0013.3051± 0.12871
OG0024.0031± 0.16880
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
0.4282
Mean Difference
-0.0547
2-Sided
95
-0.1899
0.0806
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
0.2457
Mean Difference
-0.0793
2-Sided
95
-0.2131
0.0546
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
0.0292
Mean Difference
-0.1722
2-Sided
95
-0.3270
-0.0174
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
0.0352
Mean Difference
-0.1659
2-Sided
95
-0.3202
-0.0115
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
0.0514
Mean Difference
-0.1450
2-Sided
95
-0.2909
0.0009
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
0.0265
Mean Difference
-0.1680
2-Sided
95
-0.3164
-0.0196
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
<0.0001
Mean Difference
-0.3532
2-Sided
95
-0.5245
-0.1819
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
0.0002
Mean Difference
-0.2848
2-Sided
95
-0.4336
-0.1361
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
0.0006
Mean Difference
-0.7251
2-Sided
95
-1.1373
-0.3129
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
0.0010
Mean Difference
-0.6980
2-Sided
95
-1.1142
-0.2817
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.
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
OG001163
OG002164
Title
Denominators
Categories
Title
Measurements
OG000-22.897± 4.1171
OG001-25.532± 2.7676
OG002-22.355± 2.9341
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
OG000186
OG001183
OG002178
Title
Denominators
Categories
Title
Measurements
OG000-0.408± 0.0570
OG001-0.371± 0.0562
OG002-0.360± 0.0601
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.