Trial · NCT03972709
A Study Assessing the Safety, Tolerability, and Efficacy of Galegenimab (FHTR2163) in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration (AMD)
NCT03972709, Phase 2, Terminated, Genentech, Inc.; results first posted 2024-03-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study Assessing the Safety, Tolerability, and Efficacy of Galegenimab (FHTR2163) in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration (AMD). Trials, record NCT03972709. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03972709
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Assessing the Safety, Tolerability, and Efficacy of Galegenimab (FHTR2163) in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration (AMD)
- NCT number
- NCT03972709
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 372 participants, actual
- Lead sponsor
- Genentech, Inc.
- Conditions
- Macular Degeneration, Age-Related, Geographic Atrophy
- Interventions
- Galegenimab, Sham Control
- First posted
- 2019-06-04
- Last updated
- 2024-03-27
- Results first posted
- 2024-03-27
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change in Geographic Atrophy (GA) Area From Baseline to Week 72 as Measured by Fundus Autofluorescence (FAF) | Baseline, Week 72 | 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). |
| Secondary | Percentage of Participants With Ocular Adverse Events in the Study Eye | From baseline to Week 76 | 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. |
| Secondary | Percentage of Participants With Ocular Adverse Events in the Fellow Eye | From baseline to Week 76 | 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. |
| Secondary | Percentage of Participants With Systemic Adverse Events | From baseline to Week 76 | 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. |
| Secondary | Percentage of Participants With Serious Adverse Events (SAEs) | From baseline to Week 76 | 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. |
| Secondary | Percentage of Participants With Adverse Events of Special Interest (AESIs) | From baseline to Week 76 | 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. |
| Secondary | Percentage of Participants With Adverse Events Leading to Study Discontinuation | From baseline to Week 76 | 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. |
| 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 | Baseline, Week 72 | 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. |
| Secondary | Mean Change in BCVA Score From Baseline to Week 72 as Assessed by ETDRS Chart | Baseline, Week 72 | 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. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change in Geographic Atrophy (GA) Area From Baseline to Week 72 as Measured by Fundus Autofluorescence (FAF) | Baseline, Week 72 | 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. | mm^2 | MEAN |
| SECONDARY | Percentage of Participants With Ocular Adverse Events in the Study Eye | From baseline to Week 76 | Safety analysis population included all randomized participants who received at least one dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Ocular Adverse Events in the Fellow Eye | From baseline to Week 76 | Safety analysis population included all randomized participants who received at least one dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Systemic Adverse Events | From baseline to Week 76 | Safety analysis population included all randomized participants who received at least one dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Serious Adverse Events (SAEs) | From baseline to Week 76 | Safety analysis population included all randomized participants who received at least one dose of study drug. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Adverse Events of Special Interest (AESIs) | From baseline to Week 76 | Safety analysis population included all randomized participants who received at least one dose of study drug. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Adverse Events Leading to Study Discontinuation | From baseline to Week 76 | Safety analysis population included all randomized participants who received at least one dose of study drug. | Percentage of Participants | NUMBER |
| 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 | Baseline, Week 72 | 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. | ETDRS letters | MEAN |
| SECONDARY | Mean Change in BCVA Score From Baseline to Week 72 as Assessed by ETDRS Chart | Baseline, Week 72 | 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. | ETDRS letter | MEAN |
Source ClinicalTrials.gov
Results by group27
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change in Geographic Atrophy (GA) Area From Baseline to Week 72 as Measured by Fundus Autofluorescence (FAF) | Galegenimab Q4W | 2.60 | Standard Error 0.133 | mm^2 | |
| Mean Change in Geographic Atrophy (GA) Area From Baseline to Week 72 as Measured by Fundus Autofluorescence (FAF) | Galegenimab Q8W | 2.43 | Standard Error 0.189 | mm^2 | |
| Mean Change in Geographic Atrophy (GA) Area From Baseline to Week 72 as Measured by Fundus Autofluorescence (FAF) | All Sham | 2.31 | Standard Error 0.133 | mm^2 | |
| Percentage of Participants With Ocular Adverse Events in the Study Eye | Galegenimab Q4W | 49.7 | percentage of participants | ||
| Percentage of Participants With Ocular Adverse Events in the Study Eye | Galegenimab Q8W | 48 | percentage of participants | ||
| Percentage of Participants With Ocular Adverse Events in the Study Eye | All Sham | 32.4 | percentage of participants | ||
| Percentage of Participants With Ocular Adverse Events in the Fellow Eye | Galegenimab Q4W | 29.5 | percentage of participants | ||
| Percentage of Participants With Ocular Adverse Events in the Fellow Eye | Galegenimab Q8W | 20.0 | percentage of participants | ||
| Percentage of Participants With Ocular Adverse Events in the Fellow Eye | All Sham | 22.3 | percentage of participants | ||
| Percentage of Participants With Systemic Adverse Events | Galegenimab Q4W | 57.7 | percentage of participants |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Galegenimab Q4W | 149 | |
| Overall Study | STARTED | Galegenimab Q8W | 75 | |
| Overall Study | STARTED | All Sham | 148 | |
| Overall Study | COMPLETED | Galegenimab Q4W | 67 | |
| Overall Study | COMPLETED | Galegenimab Q8W | 35 | |
| Overall Study | COMPLETED | All Sham | 72 | |
| Overall Study | NOT COMPLETED | Galegenimab Q4W | 82 | |
| Overall Study | NOT COMPLETED | Galegenimab Q8W | 40 | |
| Overall Study | NOT COMPLETED | All Sham | 76 |
Source ClinicalTrials.gov
Adverse events312
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Conjunctival haemorrhage | Eye disorders | Galegenimab Q4W | 15 | 149 | 19 |
| other | Conjunctival haemorrhage | Eye disorders | Galegenimab Q8W | 6 | 75 | 10 |
| other | Conjunctival haemorrhage | Eye disorders | All Sham | 6 | 148 | 9 |
| other | Posterior capsule opacification | Eye disorders | Galegenimab Q4W | 6 | 149 | 8 |
| other | Posterior capsule opacification | Eye disorders | Galegenimab Q8W | 3 | 75 | 3 |
| other | Posterior capsule opacification | Eye disorders | All Sham | 8 | 148 | 9 |
| other | Retinal haemorrhage | Eye disorders | Galegenimab Q4W | 7 | 149 | 8 |
| other | Retinal haemorrhage | Eye disorders | Galegenimab Q8W | 5 | 75 | 6 |
| other | Retinal haemorrhage | Eye disorders | All Sham | 8 | 148 | 14 |
| other | Vitreous detachment | Eye disorders | Galegenimab Q4W | 11 | 149 | 12 |
1 to 10 of 312Source ClinicalTrials.gov
See all 312 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Galegenimab Q4W | 5 | 149 |
| Total, all-cause mortality | Galegenimab Q8W | 1 | 75 |
| Total, all-cause mortality | All Sham | 4 | 148 |
| Total, other adverse events | Galegenimab Q4W | 53 | 149 |
| Total, other adverse events | Galegenimab Q8W | 21 | 75 |
| Total, other adverse events | All Sham | 38 | 148 |
| Total, serious adverse events | Galegenimab Q4W | 29 | 149 |
| Total, serious adverse events | Galegenimab Q8W | 16 | 75 |
| Total, serious adverse events | All Sham | 34 | 148 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42518791 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03972709
GET https://conductscience.org/api/trials/v1/NCT03972709/results?page=2