A Phase 2 interventional study of NGM621 and NGM621 in Geographic Atrophy, sponsored by NGM Biopharmaceuticals, Inc. Completed at 65 sites in United States. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2025-07-01.
Sponsored by NGM Biopharmaceuticals, Inc · Phase 2, Interventional, and Treatment
Among 131 studies in Geographic Atrophy with a site in United States — 35 open to participants now, 45 under way, 5 of them phase 3. Geographic Atrophy · United States.
Among the 131 studies in Geographic Atrophy with a site in United States, this one is the 21st largest by enrollment of the 107 interventional ones that give a count, is one of 10 that started in 2020, is one of 43 in phase 2, and was the 70th registered.
188 studies on the registry are indexed under Geographic Atrophy; 52 are open to participants now.
Browse Geographic Atrophy studies →35 of the 131 studies in Geographic Atrophy with a site in United States are open now. Recruiting first, the newest first:
Genentech, Inc. · Sites in United States
Ages 50+
Biojiva LLC · Sites in United States, Australia
Ages 55+
Sitala Bio LTD · Sites in United States, Argentina, Australia and 4 more countries
Ages 60+
University of Utah · Sites in United States
Ages 65–90
Cellio Therapeutics Inc · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 40 Geographic Atrophy studies recruiting now, 31 (78%) set no upper age limit and none (0%) stop at 75 or younger; 2 take children under 18; 4 take healthy volunteers.
This study: 55 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
131 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 33 · Phase 2 65 · Phase 3 20
First in 2000; this study’s year is marked. 10 started in 2020.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 320 is above the median of 70 across 141 interventional studies indexed under Geographic Atrophy.
Median enrollment 98 across the 107 interventional studies, 138 across the 24 observational. Of the 79 that completed or were terminated, 40 (51%) have results posted.
This tab as a report to print or save as PDF → With an account.
109 of 131 have an industry lead sponsor. The 10 most frequent:
NGM Biopharmaceuticals, Inc is the lead sponsor of 26 studies on the registry; 1 is open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.
NGM Biopharmaceuticals, Inc has 2 studies filed under Geographic Atrophy — fewer than ten, so there is no comparison to draw.
12 of the studies in Geographic Atrophy with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05949593Phase 3Belite Bio, IncPhase 3, Randomized, Placebo-Controlled Study of Tinlarebant to Explore Safety and Efficacy in Geographic Atrophy | 2027-06-30 |
| NCT06510816Phase 3Annexon, Inc.A Study Investigating the Efficacy and Safety of Intravitreal (IVT) Injections of Vonaprument (Formerly ANX007) in Participants With Dry Age-Related Macular Degeneration (AMD) With Geographic Atrophy (GA) | 2027-07-31 |
| NCT06769048Boehringer IngelheimA Study to Test Different Doses of BI 1584862 in People With a Distinct Form of Age-related Macular Degeneration (AMD) Called Geographic Atrophy | 2026-12-22 |
| NCT07747662University of Wisconsin, MadisonAdaptive Optics Scanning Light Ophthalmoscopy (AOSLO) and Microperimetry (MP) Sub-study | 2027-02 |
| NCT07144137Complement TherapeuticsA Non-Interventional Study Observing Short-Term Progression in Geographic Atrophy (GA) | 2027-03-31 |
Add all 12 to your calendar (.ics) → With an account.
Among the 131 studies in Geographic Atrophy with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Clinical diagnosis of GA secondary to AMD:
Exclusion Criteria:
Study Eye
Both Eyes
NGM621 single intravitreal (IVT) injection
Biological: NGM621
NGM621 single IVT injection
Biological: NGM621
Sham single IVT injection
Other: Sham Comparator
Sham single IVT injection
Other: Sham Comparator
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.
Time frame: 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.
Time frame: Baseline to end of study (Week 56)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline up to Week 52
Number of Anti-Drug Antibody (ADA)-Negative Participants
The incidence of anti-drug antibody (ADA) was assessed in serum.
Time frame: Baseline up to Week 52
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).
| Milestone | NGM621 Q4W | NGM621 Q8W | Sham Q4W+Q8W |
|---|---|---|---|
| Started | 108 | 105 | 107 |
| Received treatment | 108 | 104 | 106 |
| Completed | 93 | 89 | 93 |
| Not completed | 15 | 16 | 14 |
| Withdrew: Withdrew consent | 6 | 10 | 7 |
| Withdrew: Adverse event | 6 | 5 | 1 |
| Withdrew: Lost to follow-up | 2 | 0 | 3 |
| Withdrew: Other | 1 | 1 | 3 |
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.
| mm^2 per year | NGM621 Q4W | NGM621 Q8W | Sham Q4W+Q8W |
|---|---|---|---|
| The Rate of Change From Baseline in Geographic Atrophy (GA) Lesion Area | 2.243 ± 0.138 | 2.237 ± 0.140 | 2.393 ± 0.138 |
A treatment-emergent adverse event (TEAE) was an adverse event (AE) that occurred during or after the first dose of study treatment.
| Participants | NGM621 Q4W | NGM621 Q8W | Sham Q4W+Q8W |
|---|---|---|---|
| Any TEAE | 57 | 51 | 49 |
| Any Treatment-related TEAE | 6 | 5 | 1 |
| Any Serious TEAE | 8 | 8 | 3 |
| Any TEAE Leading to Treatment Discontinuation | 0 | 1 | 0 |
| Any Sight Threatening TEAE | 6 | 6 | 3 |
| Any Severe TEAE | 1 | 3 | 0 |
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.
| mm^2 | NGM621 Q4W | NGM621 Q8W | Sham Q4W+Q8W |
|---|---|---|---|
| The Change From Baseline in Geographic Atrophy (GA) Lesion Area | 2.172 ± 1.5026 | 2.235 ± 1.4203 | 2.479 ± 1.4028 |
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.
| mm^2 per year | NGM621 Q4W | NGM621 Q8W | Sham Q4W+Q8W |
|---|---|---|---|
| The Rate of Change From Baseline in the Square Root of Geographic Atropy (GA) Lesion Area | 0.389 ± 0.2352 | 0.388 ± 0.2200 | 0.423 ± 0.2225 |
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.
| score on a scale | NGM621 Q4W | NGM621 Q8W | Sham Q4W+Q8W |
|---|---|---|---|
| The Change From Baseline in Best Corrected Visual Acuity Score | -2.7 ± 9.55 | -5.6 ± 12.80 | -2.7 ± 9.71 |
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.
| score on a scale | NGM621 Q4W | NGM621 Q8W | Sham Q4W+Q8W |
|---|---|---|---|
| The Change From Baseline in Low Luminance Visual Acuity Score | 0.1 ± 12.38 | -1.4 ± 12.45 | -2.31 ± 13.00 |
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.
| score on a scale | NGM621 Q4W | NGM621 Q8W | Sham Q4W+Q8W |
|---|---|---|---|
| The Change From Baseline in Low Luminance Deficit Score | -2.9 ± 13.48 | -5.3 ± 16.16 | -0.5 ± 14.10 |
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.
| words per minute | NGM621 Q4W | NGM621 Q8W | Sham Q4W+Q8W |
|---|---|---|---|
| The Change From Baseline in Average Binocular Reading Speed | -9.17 ± 39.154 | -16.90 ± 36.853 | -8.70 ± 39.844 |
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.
| logMAR | NGM621 Q4W | NGM621 Q8W | Sham Q4W+Q8W |
|---|---|---|---|
| The Change From Baseline in Binocular Critical Print Size | -0.01 ± 0.290 | -0.01 ± 0.334 | 0 ± 0.280 |
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.
| logMAR | NGM621 Q4W | NGM621 Q8W | Sham Q4W+Q8W |
|---|---|---|---|
| The Change From Baseline in Binocular Reading Acuity | 0.047 ± 0.2760 | 0.086 ± 0.2812 | 0.058 ± 0.2455 |
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.
| score on a scale | NGM621 Q4W | NGM621 Q8W | Sham Q4W+Q8W |
|---|---|---|---|
| The Change From Baseline in Functional Reading Independence Index Composite Score | -0.14 ± 0.597 | -0.15 ± 0.512 | -0.20 ± 0.675 |
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.
| score on a scale | NGM621 Q4W | NGM621 Q8W | Sham Q4W+Q8W |
|---|---|---|---|
| The Change From Baseline in National Eye Institute Visual Functioning Questionnaire Composite Score | -1.97 ± 11.075 | -3.74 ± 10.024 | -2.96 ± 11.549 |
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.
| units/mL | NGM621 Q4W | NGM621 Q8W | Sham Q4W+Q8W |
|---|---|---|---|
| The Change From Baseline in Systemic Complement Activity (CH50) | 18.16 ± 51.339 | 24.17 ± 56.244 | 26.595 ± 54.077 |
The incidence of anti-drug antibody (ADA) was assessed in serum.
| Participants | NGM621 Q4W | NGM621 Q8W | Sham Q4W+Q8W |
|---|---|---|---|
| Number of Anti-Drug Antibody (ADA)-Negative Participants | 93 | 86 | 85 |
Collected over Adverse events were collected from screening, baseline, Week 1 and every 4 weeks thereafter up to end of study (Week 56).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| NGM621 Q4W | 4/108 (3.7%) | 32/108 (29.6%) | 33/108 (30.6%) |
| NGM621 Q8W | 2/104 (1.9%) | 24/104 (23.1%) | 34/104 (32.7%) |
| Sham Q4W+Q8W | 2/106 (1.9%) | 29/106 (27.4%) | 31/106 (29.2%) |
| Event | NGM621 Q4W | NGM621 Q8W | Sham Q4W+Q8W |
|---|---|---|---|
| Dry age-related macular degenerationEye disorders | 4/108 | 4/104 | 3/106 |
| Visual acuity reducedEye disorders | 2/108 | 3/104 | 0/106 |
| PneumoniaInfections and infestations | 0/108 | 2/104 | 3/106 |
| FallInjury, poisoning and procedural complications | 3/108 | 1/104 | 1/106 |
| Visual impairmentEye disorders | 1/108 | 2/104 | 1/106 |
| Atrial fibrillationCardiac disorders | 0/108 | 2/104 | 2/106 |
| Cardiac failure acuteCardiac disorders | 0/108 | 2/104 | 1/106 |
| COVID-19Infections and infestations | 2/108 | 0/104 | 2/106 |
| Cardiac failure congestiveCardiac disorders | 2/108 | 0/104 | 1/106 |
| COVID-19 pneumoniaInfections and infestations | 2/108 | 1/104 | 0/106 |
| Event | NGM621 Q4W | NGM621 Q8W | Sham Q4W+Q8W |
|---|---|---|---|
| Conjunctival haemorrhageEye disorders | 14/108 | 14/104 | 8/106 |
| Visual acuity reducedEye disorders | 5/108 | 8/104 | 6/106 |
| Visual impairmentEye disorders | 5/108 | 7/104 | 4/106 |
| Dry age-related macular degenerationEye disorders | 7/108 | 5/104 | 7/106 |
| Retinal haemorrhage (fellow eye)Eye disorders | 2/108 | 0/104 | 6/106 |
Demographic characteristics were assessed in the modified Intent-to-Treat population.
| Age, Continuous(years) | NGM621 Q4W | NGM621 Q8W | Sham Q4W+Q8W | Total |
|---|---|---|---|---|
| Mean | 78.5 ± 8.17 | 79.1 ± 7.51 | 77.6 ± 8.42 | 78.4 ± 8.04 |
| Sex: Female, Male(Participants) | NGM621 Q4W | NGM621 Q8W | Sham Q4W+Q8W | Total |
|---|---|---|---|---|
| Female | 67 | 63 | 68 | 198 |
| Male | 41 | 41 | 38 | 120 |
| Race/Ethnicity, Customized(Participants) | NGM621 Q4W | NGM621 Q8W | Sham Q4W+Q8W | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 1 | 1 |
| Asian | 0 | 1 | 2 | 3 |
| Black or African American | 0 | 0 | 1 | 1 |
| Multiple | 1 | 0 | 0 | 1 |
| Other | 0 | 1 | 1 | 2 |
| White | 107 | 102 | 101 | 310 |
| Region of Enrollment(participants) | NGM621 Q4W | NGM621 Q8W | Sham Q4W+Q8W | Total |
|---|---|---|---|---|
| United States | 108 | 104 | 106 | 318 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Since the study did not meet the study endpoints, there is no plan to make IPD available to other researchers.
Ran from Jul 2020 to primary completion in Aug 2022, 24 months.
Results were first posted in Jul 2025, 2 years 10 months after primary completion. A results delay was requested in May 2023.
Of 24 phase 2 interventional studies under Geographic Atrophy, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 54. This study's 24 months is below that.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: NGM-621