What side effects are associated with this type of intervention?

Common treatments for Exophthalmos, particularly those targeting the IGF-1 receptor like Linsitinib and teprotumumab, can have several side effects. Teprotumumab, an IGF-1R antibody, has been associated with muscle spasms, nausea, alopecia, diarrhea, fatigue, hyperglycemia, and hearing impairment. While specific side effects for Linsitinib are not detailed, it is reasonable to expect similar adverse effects given the shared mechanism of action. Patients should discuss these potential side effects with their healthcare provider to make an informed decision.

What prior FDA approvals exist?

Currently, there are no specific FDA-approved treatments for Exophthalmos that are directly comparable to Linsitinib, an IGF-1R inhibitor. However, treatments for thyroid eye disease (TED), which can cause Exophthalmos, often include corticosteroids, immunosuppressive agents, and in some cases, surgical interventions. The use of IGF-1R inhibitors like Linsitinib is still under investigation in clinical trials for their potential efficacy in treating moderate to severe TED.

What other types of research exist?

Promising alternatives to Linsitinib for Exophthalmos patients in 2024 may include Bevacizumab (an anti-VEGF therapy) and Everolimus (an mTORC1 inhibitor), given their efficacy in related conditions involving abnormal tissue growth.

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Small Molecule Inhibitor

Linsitinib for Thyroid Eye Disease (LIDS Trial)

Phase 2 & 3

Recruiting

Research Sponsored by VasaraGen, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Clinical diagnosis of Graves' Disease and/or autoimmune Hashimoto's thyroiditis associated with active moderate to severe TED with a CAS ≥ 4 (on the 7- item scale) for the most severely affected eye (primary study eye) at Screening and Baseline

Confirmed active TED (not sight-threatening but has an appreciable impact on daily life, with onset (as determined by patient records) within 12 months prior to the Baseline visit and usually associated with one or more of the following: lid retraction ≥ 2 mm, moderate or severe soft tissue involvement, exophthalmos ≥ 3 mm above normal for race and gender, and/or inconstant or constant diplopia.

Timeline

Screening 1 day

Treatment 24 weeks

Follow Up 5 days

Awards & highlights

Summary

This trial studies the safety and effectiveness of linsitinib, an oral medication taken regularly, in patients with moderate to severe thyroid eye disease. Linsitinib works by blocking a protein that contributes to the disease, aiming to reduce symptoms and improve eye health.

Who is the study for?

This trial is for people with active, moderate to severe thyroid eye disease (TED) that affects daily life. They should have had TED symptoms within the last year and not need immediate eye surgery or other treatments during the study. Participants must also have controlled thyroid function or mild thyroid issues.

What is being tested?

The trial tests Linsitinib, an oral medication taken twice a day, against a placebo to see if it's safe and effective for treating TED over 24 weeks. Linsitinib targets a specific protein involved in TED development.

What are the potential side effects?

While specific side effects of Linsitinib are not listed here, similar medications can cause digestive issues, fatigue, skin reactions, changes in blood sugar levels and liver enzymes. Side effects vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have Graves' Disease or Hashimoto's with severe thyroid eye disease.

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I have active thyroid eye disease impacting my daily life, diagnosed within the last year.

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My thyroid function is normal or mildly off (not more than 50% from normal levels).

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I don't need eye surgery or treatment now or during the study.

Timeline

Screening ~ 1 day1 visit

Treatment ~ 24 weeks9 visits

Follow Up ~ 5 days5 visits

Screening ~ 1 day

Treatment ~ 24 weeks

Follow Up ~5 days

This trial's timeline: 1 day for screening, 24 weeks for treatment, and 5 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Subjects who are Proptosis Responders at Week 24

Secondary study objectives

Change from Baseline in Proptosis to Week 24 (Study Eye)

Change from Baseline in the Graves' Ophthalmopathy Quality of Life (GO-QoL) Questionnaire Overall Score to Week 24.

Percentage of Subjects who are CAS Categorical Responders at Week 24 (Study Eye)

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Trial Design

3Treatment groups

Active Control

Placebo Group

Group I: Low DoseActive Control1 Intervention

Active Arm Low Dose Linsitinib

Group II: High DoseActive Control1 Intervention

Active Arm High Dose Linsitinib

Group III: PlaceboPlacebo Group1 Intervention

Placebo Arm

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Exophthalmos, often associated with thyroid eye disease (TED), is commonly treated with therapies targeting inflammation and immune response. Linsitinib, an IGF-1R inhibitor, works by blocking the insulin-like growth factor-1 receptor, which plays a role in the inflammatory and fibrotic processes of TED. This inhibition can reduce the proliferation of fibroblasts and the production of inflammatory cytokines, thereby decreasing tissue swelling and eye protrusion. Other treatments, such as corticosteroids, reduce inflammation by suppressing the immune system, while orbital radiotherapy aims to decrease inflammation and fibrosis through targeted radiation. Understanding these mechanisms is crucial for Exophthalmos patients as it helps in selecting the most appropriate treatment to manage symptoms effectively and prevent further complications.

THE ANGIOPOIETIN/TIE PATHWAY IN RETINAL VASCULAR DISEASES: A Review.A Multicountry Comparison of Real-World Management and Outcomes of Polypoidal Choroidal Vasculopathy: Fight Retinal Blindness! Cohort.Ranibizumab in monotherapy and combined with photodynamic therapy for retinal angiomatous proliferation.