CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 11 enrolled
Drug / intervention
Sub-tenon injection of saline followed by a sub-tenon injection of aflibercept +2 moredrug
Likely dose
Sub-tenon injection of saline followed by a sub-tenon injection of aflibercept 4 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04311606
NCT04311606Phase 2Completed
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Anti-VEGF Therapy for Acute Thyroid Eye Disease (AcTED Study)

Massachusetts Eye and Ear Infirmary·interventional·Posted Mar 17, 2020·Updated Dec 31, 2025

In Brief

A Phase 2 clinical trial evaluating Sub-tenon injection of saline followed by a sub-tenon injection of aflibercept, Sub-tenon injection of hyaluronidase (HA) followed by a sub-tenon injection of aflibercept, and 1 other intervention for Thyroid Eye Disease. Completed, enrolled 11 participants across 1 site.

Detailed Summary

The primary objective of this clinical trial is 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 from baseline to day 45. Participants will undergo clinical examinations and receive three injections of aflibercept with saline, aflibercept with hyaluronidase, or hyaluronidase.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsThyroid Eye Disease
CountriesUnited States
CollaboratorsRegeneron Pharmaceuticals

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedMar 17, 2020
Enrollment StartNov 2, 2020
Primary CompletionDec 17, 2024
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 6.3 years ago

Interventions

Sub-tenon injection of saline followed by a sub-tenon injection of afliberceptdrug

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 afliberceptdrug

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) alonedrug

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.