Phase 2
N=320
A Study of NGM621 in Participants With Geographic Atrophy
Geographic Atrophy
Bottom Line
View on ClinicalTrials.gov: NCT04465955 ↗Enrolled (actual)
320
Serious AEs
26.7%
Results posted
Jul 2025
Primary outcome: Primary: The Rate of Change From Baseline in Geographic Atrophy (GA) Lesion Area — 2.243; 2.237; 2.393 mm^2 per year — p=0.4345
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- NGM621 (Biological); Sham Comparator (Other)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- NGM Biopharmaceuticals, Inc
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Rate of Change From Baseline in Geographic Atrophy (GA) Lesion Area |
2.243; 2.237; 2.393 | 0.4345 |
| PRIMARY Number of Participants With Ocular Treatment-emergent Adverse Events in the Study Eye |
57; 51; 49; 6; 5; 1 | — |
| SECONDARY The Change From Baseline in Geographic Atrophy (GA) Lesion Area |
2.172; 2.235; 2.479 | — |
| SECONDARY The Rate of Change From Baseline in the Square Root of Geographic Atropy (GA) Lesion Area |
0.389; 0.388; 0.423 | — |
| SECONDARY The Change From Baseline in Best Corrected Visual Acuity Score |
-2.7; -5.6; -2.7 | — |
| SECONDARY The Change From Baseline in Low Luminance Visual Acuity Score |
0.1; -1.4; -2.31 | — |
| SECONDARY The Change From Baseline in Low Luminance Deficit Score |
-2.9; -5.3; -0.5 | — |
| SECONDARY The Change From Baseline in Average Binocular Reading Speed |
-9.17; -16.90; -8.70 | — |
| SECONDARY The Change From Baseline in Binocular Critical Print Size |
-0.01; -0.01; 0 | — |
| SECONDARY The Change From Baseline in Binocular Reading Acuity |
0.047; 0.086; 0.058 | — |
| SECONDARY The Change From Baseline in Functional Reading Independence Index Composite Score |
-0.14; -0.15; -0.20 | — |
| SECONDARY The Change From Baseline in National Eye Institute Visual Functioning Questionnaire Composite Score |
-1.97; -3.74; -2.96 | — |
| SECONDARY The Change From Baseline in Systemic Complement Activity (CH50) |
18.16; 24.17; 26.595 | — |
| SECONDARY Number of Anti-Drug Antibody (ADA)-Negative Participants |
93; 86; 85 | — |
Summary
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.
Eligibility Criteria
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:
- Total GA area must be ≥ 2.5 and ≤ 17.5 mm²
- If GA is multifocal, at least one focal lesion must be ≥ 1.25 mm² (0.5 DA), with the overall area of GA ≥ 2.5 and ≤ 17.5 mm²
- Well demarcated GA with no anatomical evidence of current or prior CNV in the study eye
Exclusion Criteria
Study Eye
- GA secondary to a condition other than AMD in either eye (e.g., monogenetic macular dystrophies like Stargardt disease, cone rod dystrophy, or toxic maculopathies)
- Any history of or active choroidal neovascularization (CNV)
Both Eyes
- Any history of or active bacterial, viral, fungal, or parasitic infection in either eye in the 3 months prior to randomization
Data sourced from ClinicalTrials.gov (NCT04465955). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.