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This is a multi-center evaluation of NGM621 in a randomized, double-masked, sham-controlled study in participants with Geographic Atrophy secondary to Age-related Macular Degeneration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NGM621 Treatment Group A (every 4 weeks) | Experimental | NGM621 single intravitreal (IVT) injection |
|
| NGM621 Treatment Group C (every 8 weeks) | Experimental | NGM621 single IVT injection |
|
| Sham Group B (every 4 weeks) | Sham Comparator | Sham single IVT injection |
|
| Sham Group D (every 8 weeks) | Sham Comparator | Sham single IVT injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NGM621 | Biological | NGM621 Dose 1 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The Rate of Change From Baseline in Geographic Atrophy (GA) Lesion Area | The rate of change from baseline in GA lesion area was measured by a non-invasive imaging technique called fundus autofluorescence (FAF) over the 52 weeks of treatment. FAF refers to the spontaneous emission of light by certain substances within the eye when exposed to a specific wavelength of light and involves quantifying the area and progression of atrophic lesions. The minimal GA lesion area is zero, the maximal GA lesion area is unknown. The higher the GA lesion area, the worse the visual outcome. | Baseline to Week 52 |
| Number of Participants With Ocular Treatment-emergent Adverse Events in the Study Eye | A treatment-emergent adverse event (TEAE) was an adverse event (AE) that occurred during or after the first dose of study treatment. | Baseline to end of study (Week 56) |
| Measure | Description | Time Frame |
|---|---|---|
| The Change From Baseline in Geographic Atrophy (GA) Lesion Area | Geographic atrophy lesion area was measured by a non-invasive imaging technique called fundus autofluorescence (FAF). FAF refers to the spontaneous emission of light by certain substances within the eye when exposed to a specific wavelength of light and involves quantifying the area and progression of atrophic lesions. The minimal GA lesion area is zero, the maximal GA lesion area is unknown. The higher the GA lesion area, the worse the visual outcome. |
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Inclusion Criteria:
Male or female (non-pregnant, non-lactating) subjects ≥ 55 years
Standard luminance BCVA score of 34 letters or better using ETDRS charts at the starting distance of 4 meters (approximately 20/200 Snellen equivalent or better) in study eye
Clinical diagnosis of GA secondary to AMD:
Exclusion Criteria:
Study Eye
Both Eyes
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| Name | Affiliation | Role |
|---|---|---|
| NGM Study Director | NGM Biopharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Associated Retina Consultants | Phoenix | Arizona | 85020 | United States | ||
| California Retina Consultants |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37314061 | Derived | 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. |
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Since the study did not meet the study endpoints, there is no plan to make IPD available to other researchers.
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A total of 320 participants who met all inclusion criteria and no exclusion criteria were randomized to 1 of 4 treatment groups (NGM621 treatment or sham comparator administered either every 4 weeks or every 8 weeks) at 65 sites in the United States. Participants were randomized to 1 of the 4 treatment groups in a ratio of 2 (NGM621 Q4W):1 (Placebo Q4W):2 (NGM621 Q8W):1 (Placebo Q8W).
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| ID | Title | Description |
|---|---|---|
| FG000 | NGM621 Q4W | Participants who were randomized to a single intravitreal (IVT) injection of 15 mg of NGM621 every 4 weeks (Q4W). |
| FG001 | NGM621 Q8W | Participants who were randomized to a single intravitreal (IVT) injection of 15 mg of NGM621 every 8 weeks (Q8W). |
| 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 | May 13, 2021 |
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| NGM621 |
| Biological |
NGM621 Dose 2 |
|
| Sham Comparator | Other | Sham Comparator |
|
| Baseline up to Week 52 |
| The Rate of Change From Baseline in the Square Root of Geographic Atropy (GA) Lesion Area | Geographic atrophy lesion area was measured by fundus autofluorescence (FAF). FAF refers to the spontaneous emission of light by certain substances within the eye when exposed to a specific wavelength of light and involves quantifying the area and progression of atrophic lesions. | Baseline up to Week 52 |
| The Change From Baseline in Best Corrected Visual Acuity Score | Best Corrected Visual Acuity Score is the best possible vision an eye can achieve with corrective lenses, typically glasses or contact lenses. BCVA was assessed by the Early Treatment of Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. ETDRS letter score is calculated when >20 letters are read correctly at 4.0 meters; the visual acuity letter score is equal to the total number of letters read correctly at 4.0 meters plus 30. If <20 letters are read correctly at 4.0 meters, the visual acuity letter score is equal to the total number of letters read correctly at 4.0 meters (number of letters recorded on line 1.0), plus the total number of letters in the first six lines read correctly at 1.0 meter. Therefore, the ETDRS letter score could result in a score of 0-100, where lower scores indicate better vision. The change from baseline in BCVA is being report with negative scores indicating an improvement in vision. | Baseline up to Week 52 |
| The Change From Baseline in Low Luminance Visual Acuity Score | Low Luminance Visual Acuity Score measures vision in low-light conditions. It was assessed by the Early Treatment of Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. ETDRS letter score is calculated when >20 letters are read correctly at 4.0 meters; the visual acuity letter score is equal to the total number of letters read correctly at 4.0 meters plus 30. If <20 letters are read correctly at 4.0 meters, the visual acuity letter score is equal to the total number of letters read correctly at 4.0 meters (number of letters recorded on line 1.0), plus the total number of letters in the first six lines read correctly at 1.0 meter. Therefore, the ETDRS letter score could result in a score of 0-100, where lower scores indicate better vision. A lower (negative) LLVA score compared to baseline indicates a decline in visual acuity. A higher (positive) LLVA score compared to baseline indicates an improvement in visual acuity. | Baseline up to Week 52 |
| The Change From Baseline in Low Luminance Deficit Score | Low Luminance Deficit (LLD) Score was assessed by the Early Treatment of Diabetic Retinopathy Study (ETDRS) letters at a starting distance of 4 meters. ETDRS letter score is calculated when >20 letters are read correctly at 4.0 meters; the visual acuity letter score is equal to the total number of letters read correctly at 4.0 meters plus 30. If <20 letters are read correctly at 4.0 meters, the visual acuity letter score is equal to the total number of letters read correctly at 4.0 meters (number of letters recorded on line 1.0), plus the total number of letters in the first six lines read correctly at 1.0 meter. Therefore, the ETDRS letter score could result in a score of 0-100, where lower scores indicate better vision. A LLD is the difference between standard visual acuity and LLVA, with a LLD >13 ETDRS letters suggesting potential visual abnormality. The change from baseline in LLD is being report with negative scores indicating an improvement in vision. | Baseline up to Week 52 |
| The Change From Baseline in Average Binocular Reading Speed | Average binocular reading speed was assessed by Minnesota Low-Vision Reading Test (MNRead) or Radner reading charts. The change from baseline in average binocular reading speed is reported with a higher (positive) reading speed (wpm) indicates better reading ability, while a lower (negative) reading speed indicates poorer reading ability. | Baseline up to Week 52 |
| The Change From Baseline in Binocular Critical Print Size | Binocular critical print size was assessed by the Minnesota Low-Vision Reading Test (MNRead) or Radner reading charts. MNRead uses a logarithmic scale (LogMAR) to represent print sizes, with each step representing a 0.1 LogMAR difference. The chart ranges from +1.3 LogMAR (equivalent to 20/400 at 40 cm) to -0.5 LogMAR (equivalent to 20/6 at 40 cm). The change from baseline in binocular critical print size is being reported with a higher (positive) LogMAR value for critical print size indicating that a person needs larger print sizes to maintain their maximum reading speed, while a lower (negative) LogMAR value indicates that they can read smaller print sizes at their maximum speed. | Baseline up to Week 52 |
| The Change From Baseline in Binocular Reading Acuity | Binocular reading acuity was assessed by the Minnesota Low-Vision Reading Test (MNRead) or Radner reading charts. MNRead uses a logarithmic scale (LogMAR) to represent print sizes, with each step representing a 0.1 LogMAR difference. The chart ranges from +1.3 LogMAR (equivalent to 20/400 at 40 cm) to -0.5 LogMAR (equivalent to 20/6 at 40 cm). Binocular reading acuity is the smallest print size (in LogMAR) that a person can read easily and accurately. The change from baseline in binocular reading acuity is being reported with a higher LogMAR value for reading acuity indicates poorer reading ability, while a lower LogMAR value indicates better reading ability. | Baseline up to Week 52 |
| The Change From Baseline in Functional Reading Independence Index Composite Score | The Functional Reading Independence (FRI) Index Composite Score is a 7-item patient questionnaire developed to evaluate the effect of geography atrophy on a patient's ability to independently perform reading activities. The FRI Index yields mean scores ranging from 1-4, with 1=unable to do and 4=totally independent. The FRI Index composite score is calculated by averaging the item-level scores across the seven questions, higher sores indicate better FRI. The change from baseline in FRI is being reported with lower (negative) values indicating a decline in FRI. | Baseline up to Week 52 |
| The Change From Baseline in National Eye Institute Visual Functioning Questionnaire Composite Score | The National Eye Institute Visual Functioning Questionnaire Composite Score is calculated by averaging the scores of the 11 vision-targeted subscales, excluding the general health rating question, on a scale of 0 to 100, with higher scores indicating better vision-related function. The change from baseline is being reported with a negative value indicating a decline in vision function. | Baseline up to Week 52 |
| The Change From Baseline in Systemic Complement Activity (CH50) | Systemic Complement Activity is a blood test that measures the overall activity of the complement system, a group of proteins crucial for the immune system's function. Low CH50 levels can be associated with certain infections. CH50 levels of 41 to 90 hemolytic units per mL (U/mL) is considered normal. The change from baseline in CH50 is being reported. | Baseline up to Week 52 |
| Number of Anti-Drug Antibody (ADA)-Negative Participants | The incidence of anti-drug antibody (ADA) was assessed in serum. | Baseline up to Week 52 |
| Bakersfield |
| California |
| 93309 |
| United States |
| Retina Vitreous Associates | Beverly Hills | California | 90211 | United States |
| Retinal Diagnostic Center | Campbell | California | 95008 | United States |
| The Retina Partners | Encino | California | 91436 | United States |
| Retina Consultants of Orange County | Fullerton | California | 92835 | United States |
| Loma Linda University Health | Loma Linda | California | 92354 | United States |
| University of California Los Angeles | Los Angeles | California | 90095 | United States |
| Northern California Retina Vitreous Associates | Mountain View | California | 94040 | United States |
| Retina Institute of California | Palm Desert | California | 92260 | United States |
| California Eye Specialists | Pasadena | California | 91107 | United States |
| Retina Consultants San Diego | Poway | California | 92064 | United States |
| Retinal Consultants Medical Group Inc | Sacramento | California | 95841 | United States |
| University of California San Francisco | San Francisco | California | 94143 | United States |
| Orange County Retina Medical Group | Santa Ana | California | 92705 | United States |
| California Retina Consultants | Santa Barbara | California | 93103 | United States |
| Retina Consultants of Southern Colorado PC | Colorado Springs | Colorado | 80909 | United States |
| Colorado Retina Associates PC | Golden | Colorado | 80401 | United States |
| New England Retina Associates PC | Waterford | Connecticut | 06385 | United States |
| Florida Eye Microsurgical Institute | Boynton Beach | Florida | 33426 | United States |
| University of Miami | Coral Gables | Florida | 33146 | United States |
| Specialty Retina Center (Coral Springs) | Coral Springs | Florida | 33067 | United States |
| Retina Group of Florida | Fort Lauderdale | Florida | 33308 | United States |
| National Ophthalmic Research Institute | Fort Myers | Florida | 33912 | United States |
| Florida Eye Associates | Melbourne | Florida | 32901 | United States |
| Retina Specialty Institute | Pensacola | Florida | 32503 | United States |
| Southern Vitreoretinal Associates | Tallahassee | Florida | 32308 | United States |
| Retina Vitreous Associates of Florida | Tampa | Florida | 33607 | United States |
| Georgia Retina PC | Marietta | Georgia | 30060 | United States |
| Gailey Eye Clinic - Bloomington | Bloomington | Illinois | 61704 | United States |
| University of Illinois | Chicago | Illinois | 60612 | United States |
| University Retina and Macula Associates, PC | Lemont | Illinois | 60439 | United States |
| Raj K. Maturi, MD, PC | Indianapolis | Indiana | 46290 | United States |
| Retina Associates, PA | Shawnee Mission | Kansas | 66204 | United States |
| Thompson Sjaarda, PA | Baltimore | Maryland | 21204 | United States |
| Elman Retina Group PA | Baltimore | Maryland | 21237 | United States |
| Ophthalmic Consultants of Boston | Boston | Massachusetts | 02114 | United States |
| Associated Retina Consultants PC | Royal Oak | Michigan | 48073 | United States |
| Associated Retina Consultants PC | Traverse City | Michigan | 49686 | United States |
| Vitreoretinal Surgery PA | Minneapolis | Minnesota | 55435 | United States |
| Deep Blue Retina Clinical Research | Southaven | Mississippi | 38671 | United States |
| Sierra Eye Associates | Reno | Nevada | 89502 | 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 |
| Albany Troy Cataract & Laser Associates | Troy | New York | 12180 | United States |
| Western Carolina Retinal Associates | Asheville | North Carolina | 18803 | United States |
| Southeast Clinical Research | Charlotte | North Carolina | 28210 | United States |
| Duke University | Durham | North Carolina | 27705 | United States |
| Sterling Research Group, Ltd. | Cincinnati | Ohio | 45219 | United States |
| Retina Associates of Cleveland | Cleveland | Ohio | 44122 | United States |
| The Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Cascade Medical Research Institute | Springfield | Oregon | 97477 | United States |
| Eye Care Specialists | Kingston | Pennsylvania | 18704 | United States |
| Retinovitreous Associates | Philadelphia | Pennsylvania | 19107 | United States |
| Black Hills Regional Eye Institute | Rapid City | South Dakota | 57701 | United States |
| Southeastern Retina Associates | Knoxville | Tennessee | 37922 | United States |
| Tennessee Retina | Nashville | Tennessee | 37203 | United States |
| Texas Retina Associates | Arlington | Texas | 76012 | United States |
| Retina Foundation of the Southwest | Dallas | Texas | 75231 | United States |
| Texas Retina Associates-Plano | Dallas | Texas | 75231 | United States |
| Retina Consultants of Houston | Houston | Texas | 77030 | United States |
| Retina Consultants of Houston | The Woodlands | Texas | 77384 | United States |
| Strategic Clinical Research Group, LLC | Willow Park | Texas | 76087 | United States |
| University of Virginia | Charlottesville | Virginia | 22903 | United States |
| Spokane Eye Clinical Research | Spokane | Washington | 99204 | United States |
| FG002 | Sham Q4W+Q8W | Participants who were either randomized to a single intravitreal (IVT) injection of sham comparator every 4 weeks (Q4W) or every 8 weeks (Q8W). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes. |
|
| Received Treatment |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Demographic characteristics were assessed in the modified Intent-to-Treat population.
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| ID | Title | Description |
|---|---|---|
| BG000 | NGM621 Q4W | Participants who were randomized to a single intravitreal (IVT) injection of 15 mg of NGM621 every 4 weeks (Q4W). |
| BG001 | NGM621 Q8W | Participants who were randomized to a single intravitreal (IVT) injection of 15 mg of NGM621 every 8 weeks (Q8W). |
| BG002 | Sham Q4W+Q8W | Participants who were either randomized to a single intravitreal (IVT) injection of sham comparator every 4 weeks (Q4W) or every 8 weeks (Q8W). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes. |
| 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 |
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| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | 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 | The Rate of Change From Baseline in Geographic Atrophy (GA) Lesion Area | The rate of change from baseline in GA lesion area was measured by a non-invasive imaging technique called fundus autofluorescence (FAF) over the 52 weeks of treatment. FAF refers to the spontaneous emission of light by certain substances within the eye when exposed to a specific wavelength of light and involves quantifying the area and progression of atrophic lesions. The minimal GA lesion area is zero, the maximal GA lesion area is unknown. The higher the GA lesion area, the worse the visual outcome. | The rate of change from baseline in the GA lesion area was assessed in the modified Intent-to-Treat population. | Posted | Mean | Standard Error | mm^2 per year | Baseline to Week 52 |
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| Primary | Number of Participants With Ocular Treatment-emergent Adverse Events in the Study Eye | A treatment-emergent adverse event (TEAE) was an adverse event (AE) that occurred during or after the first dose of study treatment. | TEAEs were assessed in the Safety Analysis Set. | Posted | Count of Participants | Participants | Baseline to end of study (Week 56) |
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| Secondary | The Change From Baseline in Geographic Atrophy (GA) Lesion Area | Geographic atrophy lesion area was measured by a non-invasive imaging technique called fundus autofluorescence (FAF). FAF refers to the spontaneous emission of light by certain substances within the eye when exposed to a specific wavelength of light and involves quantifying the area and progression of atrophic lesions. The minimal GA lesion area is zero, the maximal GA lesion area is unknown. The higher the GA lesion area, the worse the visual outcome. | The change from baseline in GA lesion area was assessed in participants with available data in the modified Intent-to-Treat population. | Posted | Mean | Standard Deviation | mm^2 | Baseline up to Week 52 |
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| Secondary | The Rate of Change From Baseline in the Square Root of Geographic Atropy (GA) Lesion Area | Geographic atrophy lesion area was measured by fundus autofluorescence (FAF). FAF refers to the spontaneous emission of light by certain substances within the eye when exposed to a specific wavelength of light and involves quantifying the area and progression of atrophic lesions. | The rate of change from baseline in the square root of GA lesion area was assessed in participants with available data in the modified Intent-to-Treat population. | Posted | Mean | Standard Deviation | mm^2 per year | Baseline up to Week 52 |
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| Secondary | The Change From Baseline in Best Corrected Visual Acuity Score | Best Corrected Visual Acuity Score is the best possible vision an eye can achieve with corrective lenses, typically glasses or contact lenses. BCVA was assessed by the Early Treatment of Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. ETDRS letter score is calculated when >20 letters are read correctly at 4.0 meters; the visual acuity letter score is equal to the total number of letters read correctly at 4.0 meters plus 30. If <20 letters are read correctly at 4.0 meters, the visual acuity letter score is equal to the total number of letters read correctly at 4.0 meters (number of letters recorded on line 1.0), plus the total number of letters in the first six lines read correctly at 1.0 meter. Therefore, the ETDRS letter score could result in a score of 0-100, where lower scores indicate better vision. The change from baseline in BCVA is being report with negative scores indicating an improvement in vision. | The change from baseline in Best Corrected Visual Acuity Score was assessed in participants with available data in the modified Intent-to-Treat population. | Posted | Mean | Standard Deviation | score on a scale | Baseline up to Week 52 |
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| Secondary | The Change From Baseline in Low Luminance Visual Acuity Score | Low Luminance Visual Acuity Score measures vision in low-light conditions. It was assessed by the Early Treatment of Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. ETDRS letter score is calculated when >20 letters are read correctly at 4.0 meters; the visual acuity letter score is equal to the total number of letters read correctly at 4.0 meters plus 30. If <20 letters are read correctly at 4.0 meters, the visual acuity letter score is equal to the total number of letters read correctly at 4.0 meters (number of letters recorded on line 1.0), plus the total number of letters in the first six lines read correctly at 1.0 meter. Therefore, the ETDRS letter score could result in a score of 0-100, where lower scores indicate better vision. A lower (negative) LLVA score compared to baseline indicates a decline in visual acuity. A higher (positive) LLVA score compared to baseline indicates an improvement in visual acuity. | The change from baseline in Low Luminance Visual Acuity Score was assessed in participants with available data in the modified Intent-to-Treat population. | Posted | Mean | Standard Deviation | score on a scale | Baseline up to Week 52 |
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| Secondary | The Change From Baseline in Low Luminance Deficit Score | Low Luminance Deficit (LLD) Score was assessed by the Early Treatment of Diabetic Retinopathy Study (ETDRS) letters at a starting distance of 4 meters. ETDRS letter score is calculated when >20 letters are read correctly at 4.0 meters; the visual acuity letter score is equal to the total number of letters read correctly at 4.0 meters plus 30. If <20 letters are read correctly at 4.0 meters, the visual acuity letter score is equal to the total number of letters read correctly at 4.0 meters (number of letters recorded on line 1.0), plus the total number of letters in the first six lines read correctly at 1.0 meter. Therefore, the ETDRS letter score could result in a score of 0-100, where lower scores indicate better vision. A LLD is the difference between standard visual acuity and LLVA, with a LLD >13 ETDRS letters suggesting potential visual abnormality. The change from baseline in LLD is being report with negative scores indicating an improvement in vision. | The change from baseline in Low Luminance Deficit Score was assessed in participants with available data in the modified Intent-to-Treat population. | Posted | Mean | Standard Deviation | score on a scale | Baseline up to Week 52 |
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| Secondary | The Change From Baseline in Average Binocular Reading Speed | Average binocular reading speed was assessed by Minnesota Low-Vision Reading Test (MNRead) or Radner reading charts. The change from baseline in average binocular reading speed is reported with a higher (positive) reading speed (wpm) indicates better reading ability, while a lower (negative) reading speed indicates poorer reading ability. | The change from baseline in Binocular Reading Speed was assessed in participants with available data in the modified Intent-to-Treat population. | Posted | Mean | Standard Deviation | words per minute | Baseline up to Week 52 |
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| Secondary | The Change From Baseline in Binocular Critical Print Size | Binocular critical print size was assessed by the Minnesota Low-Vision Reading Test (MNRead) or Radner reading charts. MNRead uses a logarithmic scale (LogMAR) to represent print sizes, with each step representing a 0.1 LogMAR difference. The chart ranges from +1.3 LogMAR (equivalent to 20/400 at 40 cm) to -0.5 LogMAR (equivalent to 20/6 at 40 cm). The change from baseline in binocular critical print size is being reported with a higher (positive) LogMAR value for critical print size indicating that a person needs larger print sizes to maintain their maximum reading speed, while a lower (negative) LogMAR value indicates that they can read smaller print sizes at their maximum speed. | The change from baseline in Binocular Critical Print Size was assessed in participants with available data in the modified Intent-to-Treat population. | Posted | Mean | Standard Deviation | logMAR | Baseline up to Week 52 |
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| Secondary | The Change From Baseline in Binocular Reading Acuity | Binocular reading acuity was assessed by the Minnesota Low-Vision Reading Test (MNRead) or Radner reading charts. MNRead uses a logarithmic scale (LogMAR) to represent print sizes, with each step representing a 0.1 LogMAR difference. The chart ranges from +1.3 LogMAR (equivalent to 20/400 at 40 cm) to -0.5 LogMAR (equivalent to 20/6 at 40 cm). Binocular reading acuity is the smallest print size (in LogMAR) that a person can read easily and accurately. The change from baseline in binocular reading acuity is being reported with a higher LogMAR value for reading acuity indicates poorer reading ability, while a lower LogMAR value indicates better reading ability. | The change from baseline in Binocular Reading Acuity was assessed in participants with available data in the modified Intent-to-Treat population. | Posted | Mean | Standard Deviation | logMAR | Baseline up to Week 52 |
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| Secondary | The Change From Baseline in Functional Reading Independence Index Composite Score | The Functional Reading Independence (FRI) Index Composite Score is a 7-item patient questionnaire developed to evaluate the effect of geography atrophy on a patient's ability to independently perform reading activities. The FRI Index yields mean scores ranging from 1-4, with 1=unable to do and 4=totally independent. The FRI Index composite score is calculated by averaging the item-level scores across the seven questions, higher sores indicate better FRI. The change from baseline in FRI is being reported with lower (negative) values indicating a decline in FRI. | The change from baseline in Functional Reading Independence Index was assessed in participants with available data in the modified Intent-to-Treat population. | Posted | Mean | Standard Deviation | score on a scale | Baseline up to Week 52 |
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| Secondary | The Change From Baseline in National Eye Institute Visual Functioning Questionnaire Composite Score | The National Eye Institute Visual Functioning Questionnaire Composite Score is calculated by averaging the scores of the 11 vision-targeted subscales, excluding the general health rating question, on a scale of 0 to 100, with higher scores indicating better vision-related function. The change from baseline is being reported with a negative value indicating a decline in vision function. | The change from baseline in National Eye Institute Visual Functioning Questionnaire was assessed in participants with available data in the modified Intent-to-Treat population. | Posted | Mean | Standard Deviation | score on a scale | Baseline up to Week 52 |
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| Secondary | The Change From Baseline in Systemic Complement Activity (CH50) | Systemic Complement Activity is a blood test that measures the overall activity of the complement system, a group of proteins crucial for the immune system's function. Low CH50 levels can be associated with certain infections. CH50 levels of 41 to 90 hemolytic units per mL (U/mL) is considered normal. The change from baseline in CH50 is being reported. | The change from baseline in Systemic Complement Activity was assessed in participants with available data in the modified Intent-to-Treat population. | Posted | Mean | Standard Deviation | units/mL | Baseline up to Week 52 |
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| Secondary | Number of Anti-Drug Antibody (ADA)-Negative Participants | The incidence of anti-drug antibody (ADA) was assessed in serum. | ADA-negative participants were assessed in participants with available data in the Safety Analysis Set. | Posted | Count of Participants | Participants | Baseline up to Week 52 |
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|
Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56).
As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
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 | NGM621 Q4W | Participants who were randomized to a single intravitreal (IVT) injection of 15 mg of NGM621 every 4 weeks (Q4W). | 4 | 108 | 32 | 108 | 33 | 108 |
| EG001 | NGM621 Q8W | Participants who were randomized to a single intravitreal (IVT) injection of 15 mg of NGM621 every 8 weeks (Q8W). | 2 | 104 | 24 | 104 | 34 | 104 |
| EG002 | Sham Q4W+Q8W | Participants who were either randomized to a single intravitreal (IVT) injection of sham comparator every 4 weeks (Q4W) or every 8 weeks (Q8W). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes. | 2 | 106 | 29 | 106 | 31 | 106 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry age-related macular degeneration | Eye disorders | MedDRA 23.0 | Systematic Assessment | Includes fellow eye serious TEAEs: N=1 NGM621 Q8W and N=2 Sham (Q4W+Q8W) |
|
| Visual acuity reduced | Eye disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Retinal artery occlusion | Eye disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Neovascular age-related macular degeneration | Eye disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Rhegmatogenous retinal detachment | Eye disorders | MedDRA 23.0 | Systematic Assessment | Only reported in fellow eye |
|
| Vitreous haemorrhage | Eye disorders | MedDRA 23.0 | Systematic Assessment | Only reported in fellow eye |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Faecaloma | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pharyngo-oesophageal diverticulum | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Confusion postoperative | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Skull fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Joint instability | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Lung squamous cell carcinoma stage II | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Intracranial haematoma | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Toxic encephalopathy | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Myelopathy | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Nervous system disorder | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Bladder outlet obstruction | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Aortic stenosis | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypertensive emergency | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival haemorrhage | Eye disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Visual acuity reduced | Eye disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dry age-related macular degeneration | Eye disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Retinal haemorrhage (fellow eye) | Eye disorders | MedDRA 23.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP, Clinical Operations | NGM Biopharmaceuticals | (650)243-5555 | ngm282@ngmbio.com |
| May 8, 2025 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D057092 | Geographic Atrophy |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
| Male |
|
| Asian |
|
| Black or African American |
|
| Multiple |
|
| Other |
|
| White |
|
Rate of Change Difference Between NGM621 Q8W and Pooled Sham |
| Random coefficient model |
Covariates included terms for time, treatment-by-time interaction, baseline fellow eye CNV status, baseline focality, and baseline GA lesion location |
| 0.4217 |
| Mean Difference (Final Values) |
| -0.155 |
| 2-Sided |
| 95 |
| -0.536 |
| 0.225 |
| Superiority |
| Participants |
|
|
|
|
|
|
| OG002 | Sham Q4W+Q8W | Participants who were either randomized to a single intravitreal (IVT) injection of sham comparator every 4 weeks (Q4W) or every 8 weeks (Q8W). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes. |
|
|
| OG002 | Sham Q4W+Q8W | Participants who were either randomized to a single intravitreal (IVT) injection of sham comparator every 4 weeks (Q4W) or every 8 weeks (Q8W). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes. |
|
|
| OG002 | Sham Q4W+Q8W | Participants who were either randomized to a single intravitreal (IVT) injection of sham comparator every 4 weeks (Q4W) or every 8 weeks (Q8W). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes. |
|
|
|
|
Participants who were either randomized to a single intravitreal (IVT) injection of sham comparator every 4 weeks (Q4W) or every 8 weeks (Q8W). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes. |
|
|
Participants who were either randomized to a single intravitreal (IVT) injection of sham comparator every 4 weeks (Q4W) or every 8 weeks (Q8W). As prespecified in the protocol, the sham comparator groups were pooled for analysis purposes.
|
|
|
|
|
|
|
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| Participants |
|
|