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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 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.
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.
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
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2020-11-02 |
| Est. Completion | 2024-12-17 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04311606
The ClinicalTrials.gov registry entry for NCT04311606 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 106-participant average among 15 other Thyroid Eye Disease trials with a reported enrollment target (90% lower). The listed sponsor is Massachusetts Eye and Ear Infirmary, which has 73 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.