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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04311606 | Anti-VEGF Therapy for Acute Thyroid Eye Disease | PHASE2 | COMPLETED | 11 | — | — | Nov 2, 2020 | Dec 17, 2024 | Dec 31, 2025 | 1 | United States |
To assess the safety and tolerability of sub-tenon aflibercept in combination with either saline or hyaluronidase (HA) in patients with acute Thyroid Eye Disease (TED) as assessed by the incidence and severity of adverse events
| Arm | Type | Description |
|---|---|---|
| Saline and aflibercept | EXPERIMENTAL | Group 1: Sub-tenon's injection of saline followed by sub-tenon injection of aflibercept |
| Hyaluronidase and aflibercept | EXPERIMENTAL | Group 2: Sub-tenon's injection of hyaluronidase (HA) followed by sub-tenon injection of aflibercept |
| Hyaluronidase alone | PLACEBO_COMPARATOR | Group 3: Sub-tenon injection of HA injection alone |
| Name | Type | Description |
|---|---|---|
| Sub-tenon injection of saline followed by a sub-tenon injection of aflibercept | DRUG | The study will randomly assign a total of eight subjects into this treatment arm to receive a sub-tenon injection of saline followed by injection of 4 mg aflibercept (total volume 1.1 ml) in the worse eye. Injections will be given three times: on day 1, day 14 and day 28. Subjects will be followed until day 90. |
| Sub-tenon injection of hyaluronidase (HA) followed by a sub-tenon injection of aflibercept | DRUG | The study will randomly assign a total of eight subjects into this treatment arm to receive a sub-tenon injection of hyaluronidase (HA) followed by injection of 4 mg aflibercept (total volume 1.1 ml) in the worse eye. Injections will be given three times: on day 1, day 14 and day 28. Subjects will be followed until day 90. |
| Sub-tenon injection of hyaluronidase (HA) alone | DRUG | The study will randomly assign a total of eight subjects into this treatment arm to receive a sub-tenon injection of hyaluronidase (HA) injection alone (total volume 1.1 ml) in the worse eye. Injections will be given three times: on day 1, day 14 and day 28. Subjects will be followed until day 90. |
Inclusion Criteria: 1. Minimum of 18 years-old 2. Active Thyroid Eye Disease 3. Clinical Activity Score (CAS) between 3 and 5, inclusive 4. Phakic and pseudophakic eyes are allowed in the study. 5. Willing and able to provide written informed consent after the nature of the study has been explained...