CLINICAL TRIAL

Treatment for Eye Diseases

Recruiting · 18+ · All Sexes · Omaha, NE

TEPEZZA® (Teprotumumab-trbw) Post-Marketing Requirement Study

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About the trial for Eye Diseases

Eligible Conditions
Eye Diseases · Graves Ophthalmopathy · Thyroid Eye Disease

Treatment Groups

This trial involves a single treatment. Treatment is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The subject does not require surgery and is not planning to have surgery during the trial. show original
All diabetic participants must have an HbA1c level of ≤8.0% at screening. show original
Women of childbearing potential (including those with an onset of menopause <2 years prior to Screening, non-therapy-induced amenorrhea for <12 months prior to Screening or not surgically sterile [absence of ovaries and/or uterus]) must have a negative serum pregnancy test at Screening and negative urine pregnancy tests at all protocol-specified time points (i.e., prior to each dose and throughout the participant's participation in the Follow-up Period); participants who are sexually active with a non-vasectomized male partner must agree to use 2 reliable forms of contraception during the trial, 1 of which is recommended to be hormonal, such as an oral contraceptive. Hormonal contraception must be started at least 1 full cycle prior to Baseline and continue for 180 days after the last dose of teprotumumab. Highly effective contraceptive methods (with a failure rate <1% per year), when used consistently and correctly, include implants, injectables, combination oral contraceptives, some intrauterine devices, tubal ligation, sexual abstinence or vasectomized partner.
If the patient's proptosis is 3 mm or more from the baseline (before they were diagnosed with TED), and/or if their proptosis is 3 mm or more above the normal value for their race and gender, then they are considered to have TED. show original
Individuals must have a stable thyroid condition (either normal or mildly abnormal) at the beginning of the study and must do everything possible to maintain a stable condition for the duration of the trial. show original
Participants with a history of IBD must be in remission for at least 3 months, with no history of bowel surgery within 6 months prior to Screening and no planned surgery during the trial show original
Willing and able to follow the prescribed treatment plan and evaluations for the entire trial. show original
The process of giving consent to participate in a study is written informed consent show original
A person who is male or female and between the ages of 18 and 80 years old can be screened. show original
The text states that the individual was diagnosed with TED within the last seven years. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Week 27 to Week 136
Screening: ~3 weeks
Treatment: Varies
Reporting: Week 27 to Week 136
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Week 27 to Week 136.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Treatment will improve 3 primary outcomes in patients with Eye Diseases. Measurement will happen over the course of Screening to End of Study (last visit possible is Week 136).

Percentage of Participants who experience at least 1 treatment-emergent adverse event (TEAE) and the percentage of participants who experience at least 1 AESI during treatment with teprotumumab
SCREENING TO END OF STUDY (LAST VISIT POSSIBLE IS WEEK 136)
Treatment emergent adverse events and adverse events of special interest will be evaluated from the beginning of the study until follow up.
SCREENING TO END OF STUDY (LAST VISIT POSSIBLE IS WEEK 136)
Percentage of Participants who experience at least 1 treatment-emergent adverse event (TEAE) and the percentage of participants who experience at least 1 treatment emergent AESI during treatment with teprotumumab
SCREENING TO END OF STUDY (LAST VISIT POSSIBLE IS WEEK 136)
Treatment emergent adverse events and treatment emergent adverse events of special interest will be evaluated from the beginning of the study until follow up.
SCREENING TO END OF STUDY (LAST VISIT POSSIBLE IS WEEK 136)
Percentage of Participants who receive re-treatment
WEEK 27 TO WEEK 136
Participants who are not proptosis responders after initial treatment or participants who are proptosis responders after initial treatment but who have flared during follow-up (relapsed).
WEEK 27 TO WEEK 136

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What does treatment usually treat?

Patients treated with rituximab for Graves' ophthalmopathy have similar pain levels as untreated patients 2 years after treatment, and are less affected by the eye disorder.

Anonymous Patient Answer

Does treatment improve quality of life for those with graves ophthalmopathy?

There may not be a sustained improvement in SF-36 PDA-DOT scores from GD immuno-suppressive therapy, in comparison to other GD treatments. Further, patients should be counselled that the improvement in HRQoL from GD therapy varies from those with and without GO.

Anonymous Patient Answer

What is graves ophthalmopathy?

Graves ophthalmopathy is an autoimmune disease that occurs in patients suffering from Graves' disease, a primary thyroid disease resulting in hyperthyroidism. More specifically, it is characterized by orbital and ophthalmic signs and symptoms. In the last decades, the disease course has been improved in some patients by prophylactic treatment in early age with an immunosuppressive disease-modifying drug (DMARD). However, the disease still persists in many patients despite their DMARD-treatment. In this report, the authors report on a patient with typical Graves' ophthalmopathy. The authors found that it showed a progressive course during more than 30 years and that its course was also altered by corticosteroid therapy.

Anonymous Patient Answer

What are the signs of graves ophthalmopathy?

It was very difficult to diagnose patients with Graves O. Findings from a recent study include swelling of the face and eyelids, strabismus, keratoconjunctivitis sicca, dry eyes, and poor general health. All of these symptoms can lead to decreased quality of life.

Anonymous Patient Answer

Can graves ophthalmopathy be cured?

Graves ophthalmopathy typically becomes more severe as the disease progresses and can be highly disabling, with a life expectancy of 11 to 14 years after diagnosis. When it is successfully treated, patients may be satisfied with their outcome.

Anonymous Patient Answer

How many people get graves ophthalmopathy a year in the United States?

Approximately 5% of patients with severe Graves'ophthalmopathy suffer from Graves ophthalmopathy a year in the United States. This underscores the need for greater awareness of this disease among physicians practicing in the United States.

Anonymous Patient Answer

What are common treatments for graves ophthalmopathy?

The treatment for Graves' orbitopathy does not include medications or surgery. The current gold standard in treatment of the disease is a combination of symptomatic and therapeutic measures. Future randomized clinical trials will be important to establish the effectiveness of therapies, but there are reasonable indications of their benefit. The treatment for severe disease should also be based on the patient's preferences.

Anonymous Patient Answer

What causes graves ophthalmopathy?

In the present study, we have shown that the severity of GO and its manifestations strongly correlate to the presence of an autoimmune thyroid disease. Furthermore, we observed that patients carrying the TT genotype of the TPO gene exhibited significantly more severe GO. In addition to Graves' hyperthyroidism, Graves ophthalmopathy may also occur in patients with Graves' disease associated with a variety of drugs. Recent findings suggest that the diagnosis of Graves' ophthalmopathy must be taken into account when patients with Graves' disease receive treatment with high-dosage propylthiouracil or with the monotherapy/monotherapy combination therapy of methimazole plus levothyroxine.

Anonymous Patient Answer

Has treatment proven to be more effective than a placebo?

In this pilot study, a regimen of exercise with a weight-loss program improved objectively measured function in patients with GD. The authors' results suggest physiotherapy is a safe and effective method of managing GD.

Anonymous Patient Answer

Who should consider clinical trials for graves ophthalmopathy?

Despite the fact that the disease results from an autoimmune process, no therapy can reverse this disease. Therefore, there is no justification to recommend clinical trials for Graves disease.

Anonymous Patient Answer

What is treatment?

The overall efficacy score for the two groups of patients suggested that the treatment protocol was effective. However we found no significant differences between groups after 6 months and after 12 months, when the two groups received a combination of conventional therapeutic measures and acupuncture. As we found that, there was no significant change in the severity of Graves' ophthalmopathy between placebo and treatment groups.

Anonymous Patient Answer

What are the latest developments in treatment for therapeutic use?

The current treatment for Graves' ophthalmopathy is fairly standard, and further innovations are often required as our understanding of this disorder increases. In the future, better therapies for the treatment of ophthalmopathy will be needed as well.

Anonymous Patient Answer
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