Treatment for Eye Diseases
TEPEZZA® (Teprotumumab-trbw) Post-Marketing Requirement Study
See full descriptionAbout the trial for Eye Diseases
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.
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.
Approximate Timelines
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).
Patient Q & A Section
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.