Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABP 938 · 3 trials · 4 indications
A successful injection was defined by whether the retinal specialist administering the IVT injection answered 'yes' to the following question: Did the PFS allow for the safe and effective administration of the prescribed dose? Percentage of successful injections and Clopper-Pearson 95% Confidence Interval is reported.
BCVA score was assessed based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart by the study eye at 4 meters. ETDRS letters score could range from 0 to 100 letters at each assessment. A positive change from Baseline in ETDRS letter score indicated an improvement in visual acuity in the study eye. Change from Baseline calculated as observed post-baseline value - Baseline value.
| Arm | Type | Description |
|---|---|---|
| ABP 938 8 mg | EXPERIMENTAL | Participants will receive intravitreal ABP 938 8 mg injections at Baseline, Week 4, and Week 8. Participants will then be assessed at scheduled study visits, with Dose Regimen Adjustment (DRA) decisions beginning at Week 16 based on predefined disease-activity criteria. Injections will be administered at protocol-defined intervals ranging from every 4 to 16 weeks through the end of the study. |
| Aflibercept (US) 8 mg | ACTIVE_COMPARATOR | Participants will receive intravitreal Aflibercept (US) 8 mg injections at Baseline, Week 4, and Week 8. Participants will then be assessed at scheduled study visits, with DRA decisions beginning at Week 16 based on predefined disease-activity criteria. Injections will be administered at protocol-defined intervals ranging from every 4 to 16 weeks through the end of the study. |
| ABP 938 | EXPERIMENTAL | Participants will be randomized in a ratio of 2:1 to receive either a single IVT injection of ABP 938 in a PFS or a single injection of aflibercept in a PFS. |
| Aflibercept | EXPERIMENTAL | Participants will be randomized in a ratio of 2:1 to receive either a single IVT injection of ABP 938 in a PFS or a single injection of aflibercept in a PFS. |
| ABP 938-Treatment Group A | EXPERIMENTAL | Subjects will receive 2 mg (0.05 mL) of ABP 938 by intravitreal (IVT) injection every 4 weeks for the first 3 doses (ie, baseline/day 1, week 4, and week 8) and every 8 weeks from week 16 until week 48. |
| Aflibercept-Treatment Group B1 | ACTIVE_COMPARATOR | Subjects will receive 2 mg (0.05 mL) of aflibercept (Treatment Group B) by IVT injection every 4 weeks for the first 3 doses (ie, baseline/day 1, week 4, and week 8). Subjects will be re-randomized to receive aflibercept by IVT injection every 8 weeks from week 16 until week 48. |
| ABP 938-Treatment group B2 | ACTIVE_COMPARATOR | Subjects will receive 2 mg (0.05 mL) of aflibercept (Treatment Group B) by IVT injection every 4 weeks for the first 3 doses (ie, baseline/day 1, week 4, and week 8). Subjects will be re-randomized to receive ABP 938 by IVT injection every 8 weeks from week 16 until week 48 |
| Name | Type | Description |
|---|---|---|
| ABP 938 8 mg | DRUG | IVT injection |
| Aflibercept (US) 8 mg | DRUG | IVT injection |
| ABP 938 | DRUG | IVT injection |
| Aflibercept | DRUG | IVT injection |
Inclusion Criteria: * Men or women ≥ 50 years old, capable of giving signed informed consent * Active, treatment-naïve subfoveal CNV lesions secondary to nAMD including juxtafoveal lesions that affect the fovea as confirmed by SD-OCT and FA in the study eye (SE) * Total area of CNV (including both ...
ABP 938 is an investigational small molecule being developed for neovascular (wet) age-related macular degeneration (AMD), a condition that causes vision loss due to abnormal blood vessel growth. It is also being studied in chorioretinal vascular disease. The drug is administered to patients aged 50 years and older in clinical trials.
ABP 938 is designed to treat neovascular (wet) age-related macular degeneration by targeting the underlying disease process. It is being compared to aflibercept (Eylea) in clinical trials, suggesting it works through a similar pathway to inhibit abnormal blood vessel growth in the eye. The specific molecular target is not disclosed.
ABP 938 is being developed by Amgen Inc., a biopharmaceutical company traded on NASDAQ under the ticker AMGN. Amgen is conducting Phase 3 clinical trials to evaluate the drug's effectiveness and safety in patients with neovascular age-related macular degeneration.
ABP 938 is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Multiple Phase 3 trials are ongoing or completed to assess its efficacy and safety compared to aflibercept in patients with neovascular age-related macular degeneration.
ABP 938 has been studied in several Phase 3 trials. NCT04270747 compared ABP 938 to aflibercept in 576 patients with wet AMD. NCT05704725 evaluated it in 49 patients with chorioretinal vascular disease. NCT07614776 is currently recruiting 304 patients to compare ABP 938 8 mg to Eylea HD.
ABP 938 8 mg refers to a specific dose of ABP 938 being tested in clinical trials. The ongoing trial NCT07614776 evaluates ABP 938 8 mg against Eylea HD (aflibercept) in patients with neovascular age-related macular degeneration, indicating this higher dose is under investigation for potential efficacy.