Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
TERMINATED
NCT04311606
PHASE2

Anti-VEGF Therapy for Acute Thyroid Eye Disease

Sponsor: Massachusetts Eye and Ear Infirmary

View on ClinicalTrials.gov

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.

Official title: Anti-VEGF Therapy for Acute Thyroid Eye Disease (AcTED Study)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

8

Start Date

2020-11-02

Completion Date

2024-12-17

Last Updated

2026-10-20

Healthy Volunteers

No

Interventions

DRUG

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

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.

DRUG

Sub-tenon injection of hyaluronidase (HA) followed by a sub-tenon injection of aflibercept

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.

DRUG

Sub-tenon injection of hyaluronidase (HA) alone

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.

Locations (1)

Mass Eye and Ear

Boston, Massachusetts, United States