Oral Prednisolone Versus Posterior Sub-Tenon Triamcinolone for Acute Ocular VKH

NCT07405489 | Completed DMC

• 2 other identifiers: VKH TreatmentBenha University
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Vogt-Koyanagi-Harada (VKH) disease is a rare autoimmune disorder characterized by bilateral ocular inflammation that may lead to serous retinal detachment and permanent visual impairment if not promptly treated. Systemic corticosteroids are commonly used as first-line therapy; however, periocular corticosteroid administration has been proposed as an alternative approach that may reduce systemic adverse effects. This retrospective cohort study reviewed the medical records of patients with acute ocular VKH disease to compare two initial treatment strategies: systemic oral prednisolone and posterior sub-Tenon triamcinolone acetonide (PST/STA). The primary objective was to evaluate control of ocular inflammation three months after treatment initiation. Secondary objectives included assessment of visual acuity changes over six months, anatomical recovery on optical coherence tomography (OCT), recurrence of inflammation, need for additional therapy, and treatment-related adverse events.

Conditions

VKH Syndrome

Keywords

Vogt-Koyanagi-Harada disease; acute uveitis; optical coherence tomography

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants Achieving Complete Control of Ocular Inflammation at 3 Months

  Complete control of ocular inflammation is defined as a composite outcome, achieved when all of the following criteria are met at the 3-month visit: Absence of active intraocular inflammation on clinical examination Complete resolution of subretinal fluid on optical coherence tomography (OCT) Stable or improved best-corrected visual acuity (BCVA) compared with baseline Unit of Measure: Proportion of participants (%)

  3 months from treatment initiation

Secondary Outcomes (3)

• Change in Best-Corrected Visual Acuity (BCVA)

  Baseline, 1 month, 3 months, and 6 months

• Resolution of Subretinal Fluid on Optical Coherence Tomography (OCT)

  Baseline, 3 months, 6 months

• Change in Central Macular Thickness (CMT)

  Baseline, 3 months, and 6 months

Study Arms (2)

Oral Prednisolone Group

Patients received oral prednisolone at 1 mg/kg/day (maximum 80 mg/day) as initial therapy for acute ocular VKH. The full dose was given for \~1 week followed by gradual taper over 3-6 weeks. Topical corticosteroids and cycloplegics were allowed as adjunct therapy.

Posterior Sub-Tenon Triamcinolone (PST/STA) Group

Patients received a posterior sub-Tenon injection of triamcinolone acetonide (40 mg/1 mL) as initial therapy for acute ocular VKH. A second injection at 4-6 weeks was administered if residual inflammation persisted. Systemic steroids were not used unless rescue criteria were met.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study included treatment-naïve adult patients with acute ocular VKH disease who received either oral prednisolone or posterior sub-Tenon triamcinolone acetonide as initial therapy. All patients had bilateral disease; both eyes received the same treatment.

You may qualify if:

• Age ≥18 years
• Diagnosis of definite or probable acute ocular Vogt-Koyanagi-Harada (VKH) disease
• Active intraocular inflammation (choroiditis, serous retinal detachment, or panuveitis)
• No prior treatment for the current VKH episode
• Minimum follow-up of 6 months with complete medical records, including BCVA and OCT data

You may not qualify if:

• Prior systemic or periocular corticosteroid therapy for VKH
• Use of immunosuppressive or biologic agents at presentation
• Pre-existing glaucoma, ocular hypertension, or advanced cataract
• Retinal diseases affecting visual outcomes (e.g., diabetic retinopathy, age-related macular degeneration)
• Incomplete medical records or missing OCT/BCVA data

Sponsors & Collaborators

• Benha University: lead
• faculty of medicine, Benha university: collaborator

Study Sites (1)

Benha University

Banhā, Benha, 13111, Egypt

Location

MeSH Terms

Conditions

Uveomeningoencephalitic Syndrome

Condition Hierarchy (Ancestors)

Autoimmune Diseases of the Nervous System; Nervous System Diseases; Uveitis; Uveal Diseases; Eye Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: January 30, 2026
• First Posted: February 12, 2026
• Study Start: January 1, 2021
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 12, 2026

Record last verified: 2026-02

Locations

EG (1)