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The benefit to risk balance did not support further treatment with galegenimab (FHTR2163).
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The purpose of this study is to evaluate the long-term safety and tolerability of intravitreal (ITV) injections of galegenimab (FHTR2163) administered every 4 weeks (Q4W) or every 8 weeks (Q8W) in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) who completed the parent study (NCT03972709/GR40973).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Galegenimab 20 mg Q4W | Experimental | Participants will receive 20 milligrams (mg) galegenimab via ITV injection every 4 weeks (Q4W). |
|
| Galegenimab 20 mg Q8W | Experimental | Participants will receive 20 mg galegenimab via ITV injection every 8 weeks (Q8W). |
|
| Galegenimab 10 mg Q4W | Experimental | Participants will receive 10 mg galegenimab via ITV injection Q4W. |
|
| Galegenimab 10 mg Q8W | Experimental | Participants will receive 10 mg galegenimab via ITV injection Q8W. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Galegenimab | Drug | Intravitreal (ITV) injections of galegenimab |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Ocular 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. Ocular AEs are the events which are localized in the ocular region. | From baseline up to Week 104 |
| Percentage of Participants With Systemic (Non-Ocular) 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. | From Baseline up to Week 104 |
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Inclusion Criteria:
Ocular Inclusion Criteria: Study Eye - If the study eye best corrected visual acuity (BCVA) letter score is ≥69 letters (Snellen equivalent of 20/40 or better), the non-study eye must have a BCVA letter score of ≥44 letters (Snellen equivalent of 20/125 or better) on visit Day 1 of the open label extension (OLE)/Week 76 of parent study.
Ocular Inclusion Criteria: Non-Study Eye
- The non-study eye must have a BCVA letter score of ≥44 letters (Snellen equivalent of 20/125 or better) if the study eye BCVA letter score is ≥69 letters (Snellen equivalent of 20/40 or better) on visit Day 1 OLE/Week 76 of parent study.
Exclusion Criteria:
Ocular Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Retina Consultants | Bakersfield | California | 93309 | United States | ||
| The Retina Partners |
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).
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| ID | Title | Description |
|---|---|---|
| FG000 | Galegenimab 10MG Q4W | Participants will receive 10 milligrams (mg) galegenimab via intravitreal (ITV) injection every 4 weeks (Q4W). |
| FG001 | Galegenimab 20MG Q4W | Participants will receive 20 mg galegenimab via ITV injection Q4W. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 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 | Sep 22, 2021 |
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The study will be masked until database lock of the parent study (NCT03972709/GR40973). After the masked period, the study will follow an open-label design. The Outcome Assessor is masked for BCVA assessments.
|
| Encino |
| California |
| 91436 |
| United States |
| Retina Consultants of Orange County | Fullerton | California | 92835-3424 | 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 |
| West Coast Retina | San Francisco | California | 94109-5520 | 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 |
| Wolfe Eye Clinic | West Des Moines | Iowa | 50266 | United States |
| Vitreo Retinal Consultants | Wichita | Kansas | 67214 | United States |
| Johns Hopkins University | Baltimore | Maryland | 21287 | United States |
| Vitreo-Retinal Associates | Grand Rapids | Michigan | 49546 | United States |
| Associated Retinal Consultants PC | Royal Oak | Michigan | 48073 | 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 |
| NJ Retina Teaneck Clinic | Toms River | New Jersey | 08755 | United States |
| NJ Retina-Toms River | Toms River | New Jersey | 08755 | United States |
| Ophthalmic Consultants of Long Island | Oceanside | New York | 11572 | 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 |
| Cleveland Clinic Foundation; Cole Eye Institute | Cleveland | Ohio | 44195-0001 | 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 |
| 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 |
| Retina Consultants of Texas | The Woodlands | Texas | 77384-4167 | United States |
| Spokane Eye Clinical Research | Spokane | Washington | 99204 | United States |
| University of Wisconsin | Madison | Wisconsin | 53705 | United States |
| FG002 | Galegenimab 10MG Q8W | Participants will receive 10 mg galegenimab via ITV injection Q8W. |
| FG003 | Galegenimab 20MG Q8W | Participants will receive 20 mg galegenimab via ITV injection Q8W. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Galegenimab 10MG Q4W | Participants will receive 10 milligrams (mg) galegenimab via intravitreal (ITV) injection every 4 weeks (Q4W). |
| BG001 | Galegenimab 20MG Q4W | Participants will receive 20 mg galegenimab via ITV injection Q4W. |
| BG002 | Galegenimab 10MG Q8W | Participants will receive 10 mg galegenimab via ITV injection Q8W. |
| BG003 | Galegenimab 20MG Q8W | Participants will receive 20 mg galegenimab via ITV injection Q8W. |
| BG004 | 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 | Percentage of Participants With Ocular 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. 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 up to Week 104 |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Systemic (Non-Ocular) 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. | Safety analysis population included all randomized participants who received at least one dose of study drug. | Posted | Number | Percentage of Participants | From Baseline up to Week 104 |
|
From baseline up to Week 104
Safety analysis population included all randomized participants who received at least one dose of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Galegenimab 10MG Q4W | Participants will receive 10 milligrams (mg) galegenimab via intravitreal (ITV) injection every 4 weeks (Q4W). | 0 | 14 | 1 | 14 | 13 | 14 |
| EG001 | Galegenimab 20MG Q4W | Participants will receive 20 mg galegenimab via ITV injection Q4W. | 3 | 70 | 13 | 70 | 26 | 70 |
| EG002 | Galegenimab 10MG Q8W | Participants will receive 10 mg galegenimab via ITV injection Q8W. | 0 | 12 | 2 | 12 | 6 | 12 |
| EG003 | Galegenimab 20MG Q8W | Participants will receive 20 mg galegenimab via ITV injection Q8W. | 1 | 48 | 10 | 48 | 14 | 48 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Blindness cortical | Eye disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Iridocyclitis | Eye disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Neovascular age-related macular degeneration | Eye disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Optic neuropathy | Eye disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Retinal artery spasm | Eye disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Uveitis | Eye disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Vitritis | Eye disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Incarcerated inguinal hernia | Gastrointestinal disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA v25.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA v25.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA v25.1 | Systematic Assessment |
| |
| Cholecystitis infective | Infections and infestations | MedDRA v25.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v25.1 | Systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA v25.1 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA v25.1 | Systematic Assessment |
| |
| Blood sodium decreased | Investigations | MedDRA v25.1 | Systematic Assessment |
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| Intraocular pressure increased | Investigations | MedDRA v25.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Hepatocellular carcinoma | 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 |
| |
| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v25.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA v25.1 | Systematic Assessment |
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| Transient ischaemic attack | Nervous system disorders | MedDRA v25.1 | Systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | Systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Gastric operation | Surgical and medical procedures | MedDRA v25.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | MedDRA v25.1 | Systematic Assessment |
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| Eye pain | Eye disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Iridocyclitis | Eye disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Iritis | Eye disorders | MedDRA v25.1 | Systematic Assessment |
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| Periorbital pain | Eye disorders | MedDRA v25.1 | Systematic Assessment |
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| Posterior capsule opacification | Eye disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Retinal haemorrhage | Eye disorders | MedDRA v25.1 | Systematic Assessment |
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| Visual impairment | Eye disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Vitreous floaters | 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 |
| |
| Toothache | Gastrointestinal disorders | MedDRA v25.1 | Systematic Assessment |
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| Pain | General disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA v25.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA v25.1 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA v25.1 | Systematic Assessment |
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| Ear infection | Infections and infestations | MedDRA v25.1 | Systematic Assessment |
| |
| Fungal foot infection | Infections and infestations | MedDRA v25.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v25.1 | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA v25.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA v25.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v25.1 | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA v25.1 | Systematic Assessment |
| |
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA v25.1 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA v25.1 | Systematic Assessment |
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| Fluid retention | Metabolism and nutrition disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Exostosis | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | Systematic Assessment |
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| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | Systematic Assessment |
| |
| Wisdom teeth removal | Surgical and medical procedures | 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 |
| Sep 19, 2023 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D057092 | Geographic Atrophy |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| 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 |
|
Participants will receive 20 mg galegenimab via ITV injection Q8W.
|
|