Graves OphthalmopathyNCT05775185
Therapeutic Efficacy of Orbital Radiotherapy in Patients With Graves' Orbitopathy
An observational study of Graves Ophthalmopathy, run by Medical University of Sofia at 1 site in Bulgaria.
Trial summary
The purpose of the present interventional study is to assess the changes in the therapeutic response, ocular manifestations of Graves' orbitopathy and quality of life during the first year after orbital radiotherapy. The main questions it aim to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Graves Ophthalmopathy
- What is being tested?
- Orbital radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 26 participants
- Where
- 1 siteBulgaria
- Study dates
- 25 Jul 2017to 25 Feb 2021
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of 26 patients with active moderate-to-severe Graves' orbitopathy. Eight of them have untreated disease and the rest have been already treated with systemic glucocorticoids. Patients with contraindications for orbital radiotherapy are excluded.
Who may be able to join
- Active moderate-to-severe Graves' orbitopathy
Who cannot join
- Contraindications for orbital radiotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Changes in Therapeutic Response, Ocular Manifestations of Graves' Orbitopathy and Quality of Life During the First Year After Orbital Radiotherapy
The purpose of the present interventional study is to assess the changes in the therapeutic response, ocular manifestations of Graves' orbitopathy and quality of life during the first year after orbital radiotherapy. The main questions it aim to answer are:
- How effective is orbital radiotherapy used as first- or second-line treatment in patients with Graves' orbitopathy?
- How does the quality of life changes after orbital radiotherapy?
Participants have active moderate-to-severe Graves' orbitopathy and are treated with low dose fractionated orbital radiotherapy for two weeks. During the follow-up period they undergo regular ocular examinations and fill out a disease-specific questionnaire.
Read the detailed description
Orbital radiotherapy is a well-established second-line therapy for moderate-to-severe forms of Graves' orbitopathy. However, the question about it efficacy is still controversial. The purpose of the present interventional study is to assess the changes in the therapeutic response, ocular manifestations of Graves' orbitopathy and quality of life during the first year after orbital radiotherapy. The main questions it aim to answer are:
- How effective is orbital radiotherapy used as first- or second-line treatment in patients with Graves' orbitopathy?
- How does the quality of life changes after orbital radiotherapy?
Participants have active moderate-to-severe Graves' orbitopathy untreated or already treated with systemic glucocorticoids and are referred to low dose fractionated orbital radiotherapy, total dose 20 Gy divided into 10 sessions, 2 Gy for each session. A concomitant intake of low-dose glucocorticoids is prescribed to all patient. During the follow-up period they undergo regular ocular examinations (at 1st, 3rd, 6th and 12th month), which includes comprehensive ocular status, hormonal and immunological testing and evaluation of the current therapeutic response. The patients also fill out a disease-specific questionnaire (at 3rd, 6th and 12th months).
- Conditions
- Graves Ophthalmopathy
- Being tested
- Orbital radiotherapy
- Medical subject headings
- Graves Ophthalmopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orbital radiotherapyRadiation
Low dose fractionated orbital radiotherapy, total dose 20 Gy in 2-week period.
| Study group | Role | What they receive |
|---|---|---|
| Orbital radiotherapy | The study includes only one group of patients treated with orbital radiotherapy for 2-week period, a total dose of 20 Gy, 2Gy for each session. Receives: Radiation: Orbital radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of orbital radiotherapy
Effect on therapeutic response and individual ocular parameters
Measured: 12 months
Effect of orbital radiotherapy on quality of life
Effect of orbital radiotherapy on disease-specific quality of life
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start25 Jul 2017
- Primary completion25 Feb 2021
- Study completion25 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Graves OphthalmopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Medical University of Sofia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariya Stoynova, Medical University of Sofia
- Investigators
- Mariya A Stoynova, Principal investigator, Medical University of Sofia: Medicinski universitet-Sofia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05775185
- Sponsor's protocol ID
- 21B /25.07.2017
- Status last verified
- Oct 2023
- First submitted
- 7 Mar 2023
- Last updated
- 19 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stoynova MA, Shinkov AD, Novoselski MT, Petrova VV, Dimitrova ID, Yankova IA, Kovatcheva RD. Changes in therapeutic response, ocular manifestations of Graves' orbitopathy and quality of life during the first year after orbital radiotherapy. Int Ophthalmol. 2023 Nov;43(11):4305-4314. doi: 10.1007/s10792-023-02842-8. Epub 2023 Aug 10.
PubMed 37561249
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Therapeutic Response, Ocular Manifestations of Graves' Orbitopathy and Quality of Life During the First Year After Orbital Radiotherapy
- ClinicalTrials.gov ID
- NCT05775185
- Acronym / sponsor ID
- 21B /25.07.2017
- Conditions
- Graves Ophthalmopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Medical University of SofiaUniversity, hospital or other
- Study start
- 25 Jul 2017 (actual)
- Primary completion
- 25 Feb 2021 (actual)
- Study completion
- 25 Feb 2021 (actual)
- First posted
- 20 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the present interventional study is to assess the changes in the therapeutic response, ocular manifestations of Graves' orbitopathy and quality of life during the first year after orbital radiotherapy. The main questions it aim to answer are:
- How effective is orbital radiotherapy used as first- or second-line treatment in patients with Graves' orbitopathy?
- How does the quality of life changes after orbital radiotherapy?
Participants have active moderate-to-severe Graves' orbitopathy and are treated with low dose fractionated orbital radiotherapy for two weeks. During the follow-up period they undergo regular ocular examinations and fill out a disease-specific questionnaire.
Detailed description
Orbital radiotherapy is a well-established second-line therapy for moderate-to-severe forms of Graves' orbitopathy. However, the question about it efficacy is still controversial. The purpose of the present interventional study is to assess the changes in the therapeutic response, ocular manifestations of Graves' orbitopathy and quality of life during the first year after orbital radiotherapy. The main questions it aim to answer are:
- How effective is orbital radiotherapy used as first- or second-line treatment in patients with Graves' orbitopathy?
- How does the quality of life changes after orbital radiotherapy?
Participants have active moderate-to-severe Graves' orbitopathy untreated or already treated with systemic glucocorticoids and are referred to low dose fractionated orbital radiotherapy, total dose 20 Gy divided into 10 sessions, 2 Gy for each session. A concomitant intake of low-dose glucocorticoids is prescribed to all patient. During the follow-up period they undergo regular ocular examinations (at 1st, 3rd, 6th and 12th month), which includes comprehensive ocular status, hormonal and immunological testing and evaluation of the current therapeutic response. The patients also fill out a disease-specific questionnaire (at 3rd, 6th and 12th months).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Orbital radiotherapy | – | Radiation: Orbital radiotherapyThe study includes only one group of patients treated with orbital radiotherapy for 2-week period, a total dose of 20 Gy, 2Gy for each session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of 26 patients with active moderate-to-severe Graves' orbitopathy. Eight of them have untreated disease and the rest have been already treated with systemic glucocorticoids. Patients with contraindications for orbital radiotherapy are excluded.
Key inclusion criteria (1 listed)
- Active moderate-to-severe Graves' orbitopathy
Key exclusion criteria (1 listed)
- Contraindications for orbital radiotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orbital radiotherapyLow dose fractionated orbital radiotherapy, total dose 20 Gy in 2-week period. | Radiation | Orbital radiotherapy |
Primary outcome
Efficacy of orbital radiotherapy
Time frame: 12 months
Effect on therapeutic response and individual ocular parameters
Effect of orbital radiotherapy on quality of life
Time frame: 12 months
Effect of orbital radiotherapy on disease-specific quality of life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
- Derived from this study: PubMed 37561249Stoynova MA, Shinkov AD, Novoselski MT, Petrova VV, Dimitrova ID, Yankova IA, Kovatcheva RD. Changes in therapeutic response, ocular manifestations of Graves' orbitopathy and quality of life during the first year after orbital radiotherapy. Int Ophthalmol. 2023 Nov;43(11):4305-4314. doi: 10.1007/s10792-023-02842-8. Epub 2023 Aug 10.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mariya A Stoynova principal investigator
Medical University of Sofia: Medicinski universitet-Sofia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Graves Ophthalmopathy, run by Medical University of Sofia at 1 site in Bulgaria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bulgaria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of orbital radiotherapy (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05775185, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2023.