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NCT04311606 · ClinicalTrials.gov registry record · Phase 2

Anti-VEGF Therapy for Acute Thyroid Eye Disease

A Phase 2 study of Thyroid Eye Disease, sponsored by Massachusetts Eye and Ear Infirmary.

Completed
Registry status
Phase 2
Development phase
11
Enrollment target
1
Study location

NCT04311606: Completed Phase 2 study of Thyroid Eye Disease, sponsored by Massachusetts Eye and Ear Infirmary.

NCT04311606 is a Phase 2 study of Thyroid Eye Disease that has completed, run by Massachusetts Eye and Ear Infirmary. The registered enrollment target is 11 participants, below the 106-participant average among 15 other Thyroid Eye Disease trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04311606, a Phase 2 study of Thyroid Eye Disease, has completed, sponsored by Massachusetts Eye and Ear Infirmary.

COMPLETED
Registry status
Phase 2
Development phase
11 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

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

Conditions Studied

Interventions

  • DRUG Sub-tenon injection of saline followed by a sub-tenon injection of aflibercept
  • DRUG Sub-tenon injection of hyaluronidase (HA) followed by a sub-tenon injection of aflibercept
  • DRUG Sub-tenon injection of hyaluronidase (HA) alone

Study Locations (1)

Massachusetts

  • Mass Eye and Ear - Boston

Trial Details

FieldValue
Enrollment Target 11 participants
Start Date 2020-11-02
Est. Completion 2024-12-17
Phase Phase 2

What the finished NCT04311606 record still lists

NCT04311606 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 106-participant average among 15 other Thyroid Eye Disease trials with a reported enrollment target (90% lower).

The record links to 1 condition, with Thyroid Eye Disease appearing as the primary indexed condition, and to 3 interventions - of which Sub-tenon injection of saline followed by a sub-tenon injection of aflibercept is the first listed.

NCT04311606 reports a single indexed study location in Massachusetts.

Frequently Asked Questions

What is clinical trial NCT04311606 about?

NCT04311606 is a clinical study titled "Anti-VEGF Therapy for Acute Thyroid Eye Disease". 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....

What is the current status of trial NCT04311606?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 11 participants. The study started on 2020-11-02. Estimated completion is 2024-12-17.

What conditions does trial NCT04311606 study?

This clinical trial studies the following conditions: Thyroid Eye Disease.

What interventions are being tested in trial NCT04311606?

The interventions under investigation include: Sub-tenon injection of saline followed by a sub-tenon injection of aflibercept (DRUG), Sub-tenon injection of hyaluronidase (HA) followed by a sub-tenon injection of aflibercept (DRUG), Sub-tenon injection of hyaluronidase (HA) alone (DRUG).

Who is sponsoring clinical trial NCT04311606?

This trial is sponsored by Massachusetts Eye and Ear Infirmary, which has 73 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04311606 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Thyroid Eye Disease

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04311606's enrollment target sits among peer trials

11 16th of 15 the lowest of 15 other Thyroid Eye Disease trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Thyroid Eye Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04311606, the US trial registry maintained by the National Library of Medicine. NCT04311606 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.