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Application of protein A immunoadsorption in thyroid-associated ophthalmopathy: a prospective, single center clinical controlled study

Application of protein A immunoadsorption in thyroid-associated ophthalmopathy: a prospective, single center clinical controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500095461
Enrollment
Unknown
Registered
2025-01-07
Start date
2025-01-30
Completion date
Unknown
Last updated
2025-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

thyroid-associated ophthalmopathy

Interventions

Protein A immunoadsorption:The first course of treatment involves protein A immunoadsorption every other day for 5 consecutive sessions. Record the therapeutic effect and administer the second course
model: WG-80-PP
source: Shandong Weigao Blood Purification Products Co., Ltd.), and a protein A immunoadsorption column (brand: Guangzhou Kangsheng, model: KCIA08, source: Guangzhou Kangsheng Biotechnology Co., Ltd.)
Methylprednisolone:500mg methylprednisolone powder injection is dissolved in 500mL of 5% glucose solution and administered intravenously once a day for 3 consecutive days
After a 3-day interval, repeat for another 3 days, and then take 60mg methylprednisolone tablets orally every day. Reduce by 10mg every 7 days until the medication is stopped. The accumulated amount o
Tocilizumab:Dissolve tocilizumab injection in 100mL of 0.9% sodium chloride solution, intravenously drip, with a single injection dose of 8mg/kg, once a month, for continuous treatment for 4-6 months.

Sponsors

The Third Xiangya Hospital, Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. TAO patients who meet the diagnostic criteria of TAO, refer to the BARTLEY diagnostic criteria, EUGOGO grading and CAScore, and are classified and staged as moderate to severe active phase. Independent statistical analysis of CAScores for both eyes, with the most severe eye as the study eye. A CAScore of >= 3 points is considered the active phase, and a CAScore of<3 points is considered the quiescent phase; 2. During the treatment period, no treatments such as orbital decompression, eyelid retraction, strabismus correction, orbital radiotherapy, or injection of hormones around or behind the ball were performed; 3. Thyroid function is basically under normal control.

Exclusion criteria

Exclusion criteria: 1. Combined inflammatory eye diseases, such as infectious keratitis, choroiditis, orbital cellulitis, etc; 2. Complicated with major systemic diseases, such as infectious diseases, autoimmune diseases, uncontrolled hypertension, poorly controlled diabetes, blood diseases, malignant tumors, liver and kidney dysfunction or severe trauma; 3. Pregnant women; 4. Severe mental illness and epilepsy.

Design outcomes

Primary

MeasureTime frame
CAScore;Exophthalmos;Palpebral fissure width;

Secondary

MeasureTime frame
GO-QOL Score;Titer of thyroid related antibodies;

Countries

China

Contacts

Public ContactXiong Wei

Department of Ophthalmology, The Third Xiangya Hospital, Central South University

weixiong420@csu.edu.cn+86 138 0846 9035

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026