Therapeutic Efficacy of Orbital Radiotherapy in Patients... | NCT05775185

Studies
Therapeutic Efficacy of Orbital Radiotherapy in Patients With Graves' Orbitopathy

NCT05775185

Sponsor

Medical University of Sofia

Status

Completed

Last Update Posted

Oct 19, 2023Actual

Enrollment

26Actual

Phase

Not provided

Conditions

Graves Ophthalmopathy

Interventions

Orbital radiotherapy

Countries

Bulgaria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 25, 2017Actual

Primary Completion Date

Feb 25, 2021Actual

Completion Date

Feb 25, 2021Actual

First Submitted Date

Mar 7, 2023

First Submission Date that Met QC Criteria

Mar 7, 2023

First Posted Date

Mar 20, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 17, 2023

Last Update Posted Date

Oct 19, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mariya Stoynova, Principal investigator, Medical University of SofiaPrincipal Investigator

Lead Sponsor

Medical University of SofiaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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:

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

12 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

26Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	Radiation: Orbital radiotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Orbital radiotherapy	Radiation	Low dose fractionated orbital radiotherapy, total dose 20 Gy in 2-week period.	Orbital radiotherapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Efficacy of orbital radiotherapy	Effect on therapeutic response and individual ocular parameters	12 months
Effect of orbital radiotherapy on quality of life	Effect of orbital radiotherapy on disease-specific quality of life	12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- Active moderate-to-severe Graves' orbitopathy

Exclusion Criteria:

Contraindications for orbital radiotherapy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mariya A Stoynova	Medical University of Sofia: Medicinski universitet-Sofia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital of Endocrinology		Sofia		1000	Bulgaria

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37561249	Derived	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.

ID	Term
D015785	Eye Diseases, Hereditary
D005128	Eye Diseases
D006111	Graves Disease
D005094	Exophthalmos