Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01331681 | Intravitreal Aflibercept Injection in Vision Impairment Due to DME | PHASE3 | COMPLETED | 406 | — | — | May 9, 2011 | Mar 30, 2015 | Nov 27, 2023 | 73 | Australia, Austria +9 |
Visual function of the study eye was assessed using the ETDRS protocol. A higher score represents better functioning.
| Arm | Type | Description |
|---|---|---|
| Intravitreal Aflibercept Injection 2Q4 | EXPERIMENTAL | Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4). |
| Intravitreal Aflibercept Injection 2Q8 | EXPERIMENTAL | Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks for 5 visits followed by injections every 8 weeks (2Q8). |
| Macular Laser Photocoagulation (Control) | ACTIVE_COMPARATOR | Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks. |
| Name | Type | Description |
|---|---|---|
| VEGF Trap-Eye (BAY86-5321) | BIOLOGICAL | Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4). |
| Macular Laser Photocoagulation (Control) | PROCEDURE | Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks. |
Inclusion Criteria: * Adults ≥ 18 years with type 1 or 2 diabetes mellitus * Subjects with DME secondary to diabetes mellitus involving the center of the macula in the study eye * Decrease in vision determined to be primarily the result of DME in the study eye * BCVA ETDRS letter score of 73 to 24 ...