Anti-VEGF Therapy for Acute Thyroid Eye Disease

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts Eye and Ear Infirmary
Study ID
NCT04311606
Phase
PHASE2
Status
Completed

Conditions

  • Thyroid Eye Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Nov 2, 2020
Status verified
Aug 2025
Primary completion
Dec 17, 2024
Completion
Dec 17, 2024

Study Design

Enrollment
11 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Saline and aflibercept
    Group 1: Sub-tenon's injection of saline followed by sub-tenon injection of aflibercept
  • Experimental: Hyaluronidase and aflibercept
    Group 2: Sub-tenon's injection of hyaluronidase (HA) followed by sub-tenon injection of aflibercept
  • Placebo Comparator: Hyaluronidase alone
    Group 3: Sub-tenon injection of HA injection alone

Primary Outcome Measure

Primary Outcome: Safety [ Time Frame: 45 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mass Eye and EarBostonMassachusetts02114-

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By research site
Mass Eye and Ear· Boston, MA

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