| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07160179 | Study to Assess the Adverse Events and How Intravitreal ABBV-6628 Moves Through the Body of Adult Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration | PHASE1 | RECRUITING | 66 | — | — | Aug 13, 2025 | Oct 1, 2029 | Feb 12, 2026 | 4 | United States |
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Number of participants with abnormal change in physical examinations in areas like cardiovascular, respiratory, gastrointestinal, and neurological systems will be assessed.
Number of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.
12-lead resting ECGs will be recorded. Parameters include heart rate, PR interval, QT interval, QRS duration, and QT interval corrected using Fridericia's formula (QTcF).
Number of participants with abnormal change in clinical laboratory test results like hematology will be assessed.
BCVA measured by Early Treatment Diabetic Retinopathy Study (ETDRS) (normal luminance and low luminance visual acuity)
Changes in Slit lamp biomicroscopy assessed by the physician will be assessed.
Measured by using Goldmann applanation tonometry (GAT) or hand-held tonometer
Changes in Lens examination assessed by the physician will be assessed.
Changes in Ophthalmoscopy assessed by the physician will be assessed.
Fundus autofluorescence (FAF) imaging assessed by Investigator
Measured by color fundus photography (CFP) imaging assessed by Investigator
Spectral domain optical coherence tomography (SD-OCT)
Fluorescein angiography (FA) assessed by Investigator
Choroidal Neovascularization (CNV) assessed by Investigator.
Post-treatment Administration Assessment (study eye only)
Cmax of ABBV-6628
Tmax of ABBV-6628
AUC0-Tlast of ABBV-6628
Ctrough of ABBV-6628
| Arm | Type | Description |
|---|---|---|
| ABBV-6628: Stage 1-Cohort 1 | EXPERIMENTAL | Participants will receive a single dose of ABBV-6628 in Cohort 1 on day 1. |
| ABBV-6628: Stage 1 -Cohort 2 | EXPERIMENTAL | Participants will receive a single dose of ABBV-6628 in Cohort 2 on day 1. |
| ABBV-6628: Stage 1 -Cohort 3 | EXPERIMENTAL | Participants will receive a single dose of ABBV-6628 in Cohort 3 on day 1. |
| ABBV-6628: Stage 1 -Cohort 4 | EXPERIMENTAL | Participants will receive ABBV-6628 in Cohort 4 on day 1 and month 2. |
| ABBV-6628: Stage 2 | EXPERIMENTAL | Participants will receive ABBV-6628 for approximately 22 months followed by 3 months of follow-up. |
| SYFOVRE: Stage 2 | EXPERIMENTAL | Participants will receive SYFOVRE for approximately 22 months followed by 3 months of follow-up. |
| Name | Type | Description |
|---|---|---|
| ABBV-6628 | DRUG | Intravitreal injection |
| SYFOVRE | DRUG | Intravitreal injection |
Inclusion Criteria: Stage 1 and Stage 2 -Diagnosed with Geographic atrophy (GA) secondary to age-related macular degeneration (AMD) in the study eye. Stage 1 * Foveal or non-foveal GA with total GA lesion area ≥ 0.5 DA (1.25 mm2) in the study eye, as assessed by the investigator at Screening and...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Regeneron Pharmaceuticals, Inc. | REGN | 2 | PHASE3 | Pozelimab, Cemdisiran |
| Belite Bio, Inc. ADR | BLTE | 1 | PHASE3 | Tinlarebant |
| Annexon, Inc. | ANNX | 1 | PHASE3 | Vonaprument |
| Johnson & Johnson | JNJ | 1 | PHASE2 | JNJ-81201887 |
| AbbVie, Inc. | ABBV | 1 | PHASE1 | ABBV-6628, SYFOVRE |
| Sanofi SA Sponsored ADR | SNY | 1 | PHASE1 | SAR446597, Sham Comparator |
| Ocugen Inc | OCGN | 1 | PHASE1 | OCU410 |
| Apellis Pharmaceuticals, Inc. | APLS | 1 | — | Pegcetacoplan |