Not provided
Not provided
Not provided
Not provided
The benefit to risk balance did not support further treatment with galegenimab (FHTR2163).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will evaluate the safety, tolerability, and efficacy of intravitreal injections of galegenimab (FHTR2163) administered every 4 weeks (Q4W) or every 8 weeks (Q8W) for approximately 76 weeks in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) compared with sham control. After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab (FHTR2163) injections.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Galegenimab Q4W | Experimental | Participants will receive galegenimab every 4 weeks (Q4W). After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab injections. |
|
| Sham Control Q4W | Sham Comparator | Participants will receive Sham-control Q4W. After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab injections. |
|
| Galegenimab Q8W | Experimental | Participants will receive galegenimab every 8 weeks (Q8W). After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab injections. |
|
| Sham Control Q8W | Sham Comparator | Participants will receive Sham-control Q8W. After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab injections. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Galegenimab | Drug | Intravitreal (ITV) injections of galegenimab |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Geographic Atrophy (GA) Area From Baseline to Week 72 as Measured by Fundus Autofluorescence (FAF) | GA is an advanced stage of age-related macular degeneration (AMD) and is characterized by loss of photoreceptors, retinal pigment epithelium, and choriocapillaris. In the early stages of GA, patients typically show minimal changes in central visual acuity although patients often still experience significant symptoms from visual dysfunction, such as reduced contrast sensitivity, and a decrease in reading speed. In the later stages, as the GA lesion expands into the fovea, a profound decrease in central visual acuity occurs with a decline in activities of daily living. The change in GA lesion area was measured by FAF and analysis of FAF images was performed by the central reading center. A positive change from baseline indicates an increase in size of GA lesion area (worsening; disease progression). | Baseline, Week 72 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Ocular Adverse Events in the Study Eye | An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, or any deterioration in a laboratory value or other clinical test. Ocular AEs are the events which are localized in the ocular region. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Ocular Exclusion Criteria, Study Eye:
Ocular Exclusion Criteria, Both Eyes:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Retina and Vitreous Consultants | Phoenix | Arizona | 85016 | United States | ||
| Retina Associates Southwest PC |
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Galegenimab Q4W | Participants will receive galegenimab every 4 weeks (Q4W). After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab injections. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 23, 2023 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Sham Control | Drug | Sham control |
|
| From baseline to Week 76 |
| Percentage of Participants With Ocular Adverse Events in the Fellow Eye | An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, or any deterioration in a laboratory value or other clinical test. Ocular AEs are the events which are localized in the ocular region. | From baseline to Week 76 |
| Percentage of Participants With Systemic Adverse Events | An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, or any deterioration in a laboratory value or other clinical test. Non-ocular AEs were the systemic events. | From baseline to Week 76 |
| Percentage of Participants With Serious Adverse Events (SAEs) | SAEs are defined as fatal, life threatening, requires or prolongs patient hospitalization, results in persistent or significant disability/incapacity, or is a significant medical event in the investigator's judgement. | From baseline to Week 76 |
| Percentage of Participants With Adverse Events of Special Interest (AESIs) | AESIs include 1.) cases of potential drug-induced liver injury that include an elevated alanine transaminase (ALT) or aspartate aminotransferase (AST) in combination with either an elevated bilirubin or clinical jaundice, as defined by Hy's Law 2.) Suspected transmission of an infectious agent by galegenimab 3.) AEs resulting from medication error 4.) Sight-threatening AEs of the following criteria: It causes a decrease of >= 30 letters in visual acuity (VA) score, compared with the most recent prior VA assessment, that lasts more than 1 hour and is attributable to galegenimab; it requires surgical intervention to prevent permanent loss of sight; associated with severe (Grade 4+) intraocular inflammation (IOI) and/or IOI-associated retinal vasculitis; in the opinion of the investigator, it may require medical intervention to prevent permanent loss of sight. | From baseline to Week 76 |
| Percentage of Participants With Adverse Events Leading to Study Discontinuation | An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, or any deterioration in a laboratory value or other clinical test. Non-ocular AEs were the systemic events. | From baseline to Week 76 |
| Mean Change in Best Corrected Visual Acuity (BCVA) Score From Baseline to Week 72 as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart Under Low-luminance Conditions | BCVA score was based on the number of letters read correctly on the ETDRS visual acuity chart assessed at a starting distance of 4 meters (m) under low-luminance conditions. A decrease in the VA score indicates a worsening in visual acuity. BCVA score testing was performed prior to dilating the eyes. BCVA score ranges from 0 to 100 letters in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A negative change from baseline indicates a decrease in the visual acuity. | Baseline, Week 72 |
| Mean Change in BCVA Score From Baseline to Week 72 as Assessed by ETDRS Chart | BCVA score was based on the number of letters read correctly on the ETDRS visual acuity chart assessed at a starting distance of 4 meters (m). A decrease in the VA score indicates a worsening in visual acuity. BCVA score testing was performed prior to dilating the eyes. BCVA score ranges from 0 to 100 letters in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A negative change from baseline indicates a decrease in the visual acuity. | Baseline, Week 72 |
| Tucson |
| Arizona |
| 85704 |
| 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 |
| Retina Consultants of Orange County | Fullerton | California | 92835-3424 | United States |
| Jules Stein Eye Institute/ UCLA | Los Angeles | California | 90095-7000 | United States |
| Northern California Retina Vitreous Associates | Mountain View | California | 94040 | United States |
| Retina Consultants, San Diego | Poway | California | 92064 | United States |
| Retinal Consultants Med Group | Sacramento | California | 95825 | United States |
| W Coast Retina Med Group Inc | San Francisco | California | 94107 | United States |
| California Retina Consultants | Santa Barbara | California | 93103 | United States |
| California Retina Consultants - Santa Maria | Santa Maria | California | 93454 | United States |
| Bay Area Retina Associates | Walnut Creek | California | 94598 | United States |
| Retina Consultants of Southern Colorado PC | Colorado Springs | Colorado | 80909 | United States |
| Southwest Retina Consultants | Durango | Colorado | 81303 | United States |
| Colorado Retina Associates, PC | Lakewood | Colorado | 80228 | United States |
| Rand Eye | Deerfield Beach | Florida | 33064 | United States |
| Florida Eye Associates - Melbourne 2nd Office | Melbourne | Florida | 32901 | United States |
| Retina Specialty Institute | Pensacola | Florida | 32503 | United States |
| Retina Vitreous Assoc of FL | St. Petersburg | Florida | 33711 | United States |
| Southern Vitreoretinal Associates | Tallahassee | Florida | 32308 | United States |
| Southeast Retina Center | Augusta | Georgia | 30909 | United States |
| Georgia Retina PC | Marietta | Georgia | 30060-1137 | United States |
| Illinois Eye and Ear Infirmary | Chicago | Illinois | 60612 | United States |
| University Retina and Macula Associates, PC | Oak Forest | Illinois | 60452 | United States |
| Wolfe Eye Clinic | West Des Moines | Iowa | 50266 | United States |
| Vitreo Retinal Consultants | Wichita | Kansas | 67214 | United States |
| Maine Eye Center | Portland | Maine | 04101 | United States |
| The Retina Care Center | Baltimore | Maryland | 21209 | United States |
| Johns Hopkins Hospital. | Baltimore | Maryland | 21287 | United States |
| Retina Group of Washington | Chevy Chase | Maryland | 20815 | United States |
| Cumberland Valley Retina Consultants | Hagerstown | Maryland | 21740-5940 | United States |
| Mass Eye and Ear Infirmary | Boston | Massachusetts | 02114 | United States |
| Vitreo-Retinal Associates | Grand Rapids | Michigan | 49546 | United States |
| Associated Retinal Consultants PC | Royal Oak | Michigan | 48073 | United States |
| VitreoRetinal Surgery, PLLC.; DBA Retina Consultants of Minnesota | Edina | Minnesota | 55435 | United States |
| Midwest Vision Research Foundation | Chesterfield | Missouri | 63017 | United States |
| The Retina Institute | St Louis | Missouri | 63128 | United States |
| Sierra Eye Associates | Reno | Nevada | 89502 | United States |
| Envision Ocular, LLC | Bloomfield | New Jersey | 07003 | United States |
| Mid Atlantic Retina | Cherry Hill | New Jersey | 08034 | United States |
| Retina Associates of NJ | Teaneck | New Jersey | 07666 | United States |
| Retina Vitreous Center, PA | Toms River | New Jersey | 08755 | United States |
| Long Is. Vitreoretinal Consult | Hauppauge | New York | 11788 | United States |
| Ophthalmic Consultants of Long Island | Oceanside | New York | 11572 | United States |
| Retina Associates of Western New York | Rochester | New York | 14620 | United States |
| The Retina Consultants | Slingerlands | New York | 12159 | United States |
| Western Carolina Retinal Associate PA | Asheville | North Carolina | 28803 | United States |
| Charlotte Eye Ear Nose and Throat Associates PA | Charlotte | North Carolina | 28210 | United States |
| Cincinnati Eye Institute | Cincinnati | Ohio | 45242 | United States |
| Retina Assoc of Cleveland Inc | Cleveland | Ohio | 44122 | United States |
| Cleveland Clinic Foundation; Cole Eye Institute | Cleveland | Ohio | 44195-0001 | United States |
| Ohio State University | Columbus | Ohio | 43212-3153 | United States |
| Retina Associates of Cleveland - Middleburg Heights Location | Middleburg Heights | Ohio | 44130 | United States |
| Retina Associates of Cleveland - Youngstown Location | Youngstown | Ohio | 44505 | United States |
| Casey Eye Institute | Portland | Oregon | 97239 | United States |
| Mid Atlantic Retina - Wills Eye Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| Palmetto Retina Center | West Columbia | South Carolina | 29169 | United States |
| Southeastern Retina Associates Chattanooga | Chattanooga | Tennessee | 37421 | United States |
| Charles Retina Institute | Germantown | Tennessee | 38138 | United States |
| Tennessee Retina PC | Nashville | Tennessee | 37203 | United States |
| Retina Res Institute of Texas | Abilene | Texas | 79606 | United States |
| Austin Retina Associates | Austin | Texas | 78705-1169 | United States |
| Austin Clinical Research LLC | Austin | Texas | 78750 | United States |
| Retina Foundation of the Southwest | Dallas | Texas | 75231 | United States |
| Medical Center Ophthalmology Associates | San Antonio | Texas | 78240 | United States |
| Retina Consultants of Texas | The Woodlands | Texas | 77384-4167 | United States |
| Retina Consultants of Houston | The Woodlands | Texas | 77384 | United States |
| Rocky Mountain Retina | Salt Lake City | Utah | 84107 | United States |
| Spokane Eye Clinical Research | Spokane | Washington | 99204 | United States |
| University of Wisconsin | Madison | Wisconsin | 53705 | United States |
| Galegenimab Q8W |
Participants will receive galegenimab every 8 weeks (Q8W). After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab injections. |
| FG002 | All Sham | Participants will receive Sham-control Q4W or Q8W. After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab injections. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Galegenimab Q4W | Participants will receive galegenimab every 4 weeks (Q4W). After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab injections. |
| BG001 | Galegenimab Q8W | Participants will receive galegenimab every 8 weeks (Q8W). After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab injections. |
| BG002 | All Sham | Participants will receive Sham-control Q4W or Q8W. After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab injections. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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 | Mean Change in Geographic Atrophy (GA) Area From Baseline to Week 72 as Measured by Fundus Autofluorescence (FAF) | GA is an advanced stage of age-related macular degeneration (AMD) and is characterized by loss of photoreceptors, retinal pigment epithelium, and choriocapillaris. In the early stages of GA, patients typically show minimal changes in central visual acuity although patients often still experience significant symptoms from visual dysfunction, such as reduced contrast sensitivity, and a decrease in reading speed. In the later stages, as the GA lesion expands into the fovea, a profound decrease in central visual acuity occurs with a decline in activities of daily living. The change in GA lesion area was measured by FAF and analysis of FAF images was performed by the central reading center. A positive change from baseline indicates an increase in size of GA lesion area (worsening; disease progression). | Modified intent-to-treat (mITT) population includes all randomized patients who received at least one dose of study drug, and have a baseline measurement and at least one post-baseline measurement of GA area by FAF, subjects grouped according to treatment assigned at randomization. Participants analyzed in this outcome measure were those included in mixed models for repeated measures (MMRM) analysis. | Posted | Mean | Standard Error | mm^2 | Baseline, Week 72 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Ocular Adverse Events in the Study Eye | An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, or any deterioration in a laboratory value or other clinical test. Ocular AEs are the events which are localized in the ocular region. | Safety analysis population included all randomized participants who received at least one dose of study drug. | Posted | Number | percentage of participants | From baseline to Week 76 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Ocular Adverse Events in the Fellow Eye | An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, or any deterioration in a laboratory value or other clinical test. Ocular AEs are the events which are localized in the ocular region. | Safety analysis population included all randomized participants who received at least one dose of study drug. | Posted | Number | percentage of participants | From baseline to Week 76 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Systemic Adverse Events | An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, or any deterioration in a laboratory value or other clinical test. Non-ocular AEs were the systemic events. | Safety analysis population included all randomized participants who received at least one dose of study drug. | Posted | Number | percentage of participants | From baseline to Week 76 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Serious Adverse Events (SAEs) | SAEs are defined as fatal, life threatening, requires or prolongs patient hospitalization, results in persistent or significant disability/incapacity, or is a significant medical event in the investigator's judgement. | Safety analysis population included all randomized participants who received at least one dose of study drug. | Posted | Number | Percentage of Participants | From baseline to Week 76 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Adverse Events of Special Interest (AESIs) | AESIs include 1.) cases of potential drug-induced liver injury that include an elevated alanine transaminase (ALT) or aspartate aminotransferase (AST) in combination with either an elevated bilirubin or clinical jaundice, as defined by Hy's Law 2.) Suspected transmission of an infectious agent by galegenimab 3.) AEs resulting from medication error 4.) Sight-threatening AEs of the following criteria: It causes a decrease of >= 30 letters in visual acuity (VA) score, compared with the most recent prior VA assessment, that lasts more than 1 hour and is attributable to galegenimab; it requires surgical intervention to prevent permanent loss of sight; associated with severe (Grade 4+) intraocular inflammation (IOI) and/or IOI-associated retinal vasculitis; in the opinion of the investigator, it may require medical intervention to prevent permanent loss of sight. | Safety analysis population included all randomized participants who received at least one dose of study drug. | Posted | Number | Percentage of Participants | From baseline to Week 76 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Adverse Events Leading to Study Discontinuation | An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, or any deterioration in a laboratory value or other clinical test. Non-ocular AEs were the systemic events. | Safety analysis population included all randomized participants who received at least one dose of study drug. | Posted | Number | Percentage of Participants | From baseline to Week 76 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change in Best Corrected Visual Acuity (BCVA) Score From Baseline to Week 72 as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart Under Low-luminance Conditions | BCVA score was based on the number of letters read correctly on the ETDRS visual acuity chart assessed at a starting distance of 4 meters (m) under low-luminance conditions. A decrease in the VA score indicates a worsening in visual acuity. BCVA score testing was performed prior to dilating the eyes. BCVA score ranges from 0 to 100 letters in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A negative change from baseline indicates a decrease in the visual acuity. | mITT population includes all randomized patients who received at least one dose of study drug, and have a baseline measurement and at least one post-baseline measurement of GA area by FAF, subjects grouped according to treatment assigned at randomization. Participants analyzed in this outcome measure were those included in mixed models for repeated measures (MMRM) analysis. | Posted | Mean | Standard Error | ETDRS letters | Baseline, Week 72 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change in BCVA Score From Baseline to Week 72 as Assessed by ETDRS Chart | BCVA score was based on the number of letters read correctly on the ETDRS visual acuity chart assessed at a starting distance of 4 meters (m). A decrease in the VA score indicates a worsening in visual acuity. BCVA score testing was performed prior to dilating the eyes. BCVA score ranges from 0 to 100 letters in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A negative change from baseline indicates a decrease in the visual acuity. | mITT population includes all randomized patients who received at least one dose of study drug, and have a baseline measurement and at least one post-baseline measurement of GA area by FAF, subjects grouped according to treatment assigned at randomization. Participants analyzed in this outcome measure were those included in mixed models for repeated measures (MMRM) analysis. | Posted | Mean | Standard Error | ETDRS letter | Baseline, Week 72 |
|
From baseline to Week 76
Safety analysis population included all randomized participants who received at least one dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Galegenimab Q4W | Participants will receive galegenimab every 4 weeks (Q4W). After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab injections. | 5 | 149 | 29 | 149 | 53 | 149 |
| EG001 | Galegenimab Q8W | Participants will receive galegenimab every 8 weeks (Q8W). After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab injections. | 1 | 75 | 16 | 75 | 21 | 75 |
| EG002 | All Sham | Participants will receive Sham-control Q4W or Q8W. After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab injections. | 4 | 148 | 34 | 148 | 38 | 148 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood loss anaemia | Blood and lymphatic system disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Normocytic anaemia | Blood and lymphatic system disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Torsade de pointes | Cardiac disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Deafness unilateral | Ear and labyrinth disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Choroidal neovascularisation | Eye disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Iridocyclitis | Eye disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Macular hole | Eye disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Ocular hypertension | Eye disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Retinal artery spasm | Eye disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Retinopathy proliferative | Eye disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Uveitis | Eye disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Vitritis | Eye disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Faecaloma | Gastrointestinal disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Pancreatitis relapsing | Gastrointestinal disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Tooth impacted | Gastrointestinal disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Swelling | General disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Swelling face | General disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Pneumobilia | Hepatobiliary disorders | MedDRA v25.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA v25.1 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA v25.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA v25.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA v25.1 | Systematic Assessment |
| |
| Empyema | Infections and infestations | MedDRA v25.1 | Systematic Assessment |
| |
| Endophthalmitis | Infections and infestations | MedDRA v25.1 | Systematic Assessment |
| |
| Kidney infection | Infections and infestations | MedDRA v25.1 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA v25.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v25.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v25.1 | Systematic Assessment |
| |
| Vascular graft infection | Infections and infestations | MedDRA v25.1 | Systematic Assessment |
| |
| Anaesthetic complication | Injury, poisoning and procedural complications | MedDRA v25.1 | Systematic Assessment |
| |
| Cervical vertebral fracture | Injury, poisoning and procedural complications | MedDRA v25.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v25.1 | Systematic Assessment |
| |
| Fracture displacement | Injury, poisoning and procedural complications | MedDRA v25.1 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA v25.1 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA v25.1 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA v25.1 | Systematic Assessment |
| |
| Blood sodium decreased | Investigations | MedDRA v25.1 | Systematic Assessment |
| |
| Intraocular pressure increased | Investigations | MedDRA v25.1 | Systematic Assessment |
| |
| SARS-CoV-2 test positive | Investigations | MedDRA v25.1 | Systematic Assessment |
| |
| Troponin increased | Investigations | MedDRA v25.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v25.1 | Systematic Assessment |
| |
| Chronic lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v25.1 | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v25.1 | Systematic Assessment |
| |
| Desmoplastic melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v25.1 | Systematic Assessment |
| |
| Gastric cancer stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v25.1 | Systematic Assessment |
| |
| Lung carcinoma cell type unspecified stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v25.1 | Systematic Assessment |
| |
| Metastatic renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v25.1 | Systematic Assessment |
| |
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v25.1 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v25.1 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Generalised tonic-clonic seizure | Nervous system disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Myoclonus | Nervous system disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Device dislocation | Product Issues | MedDRA v25.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Aortic stenosis | Vascular disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Hypertensive urgency | Vascular disorders | MedDRA v25.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival haemorrhage | Eye disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Posterior capsule opacification | Eye disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Retinal haemorrhage | Eye disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Vitreous detachment | Eye disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Vitreous floaters | Eye disorders | MedDRA v25.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA v25.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v25.1 | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 | genentech@druginfo.com |
| Oct 26, 2023 |
| Prot_SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D057092 | Geographic Atrophy |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Difference in Adjusted Means |
| 0.12 |
| Standard Error of the Mean |
| 0.231 |
| 95 |
| -0.34 |
| 0.57 |
| Superiority |
Participants will receive Sham-control Q4W or Q8W. After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab injections. |
|
|
Participants will receive Sham-control Q4W or Q8W. After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab injections. |
|
|
Participants will receive Sham-control Q4W or Q8W. After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab injections.
|
|
|
|
Participants will receive galegenimab every 8 weeks (Q8W). After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab injections.
| OG002 | All Sham | Participants will receive Sham-control Q4W or Q8W. After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab injections. |
|
|
Participants will receive Sham-control Q4W or Q8W. After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab injections. |
|
|
Participants will receive galegenimab every 8 weeks (Q8W). After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab injections.
| OG002 | All Sham | Participants will receive Sham-control Q4W or Q8W. After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab injections. |
|
|
|
| OG002 | All Sham | Participants will receive Sham-control Q4W or Q8W. After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab injections. |
|
|
|