VKH SyndromeVKH-OCNCT07405489
Oral Prednisolone Versus Posterior Sub-Tenon Triamcinolone for Acute Ocular VKH
An observational study of VKH Syndrome, run by Benha University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- VKH Syndrome
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2021to 1 Dec 2025
- 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: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective Comparative Cohort Study Evaluating the Efficacy, Anatomical Outcomes, Recurrence Rates, and Safety of Oral Prednisolone Versus Posterior Sub-Tenon Triamcinolone Acetonide as Initial Therapy in Acute Ocular Vogt-Koyanagi-Harada Disease
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.
Read the detailed description
This retrospective comparative observational cohort study evaluated the efficacy and safety of oral prednisolone versus posterior sub-Tenon triamcinolone acetonide (PST/STA) as initial therapy for acute ocular Vogt-Koyanagi-Harada (VKH) disease. The study was conducted at the Ophthalmology Department, Faculty of Medicine, Benha University, Egypt, through a review of electronic and paper-based medical records of patients treated between January 2021 and December 2025.
Eligible patients were adults diagnosed with acute ocular VKH disease who had not received prior systemic or periocular corticosteroid therapy and who had a minimum follow-up duration of six months. Patients were managed according to routine clinical practice and received either systemic oral prednisolone or PST/STA as initial treatment, based on treating physician discretion. Both eyes of each patient were treated using the same modality, and analyses were performed at the patient level.
Patients in the oral prednisolone group received an initial dose of approximately 1 mg/kg/day (maximum 80 mg/day), followed by gradual tapering over 3-6 weeks. Patients in the PST/STA group received a posterior sub-Tenon injection of triamcinolone acetonide (40 mg/1 mL), with repeat injection considered if clinically indicated. Topical corticosteroids and cycloplegics were permitted in both groups. Systemic corticosteroids were reserved as rescue therapy in the PST/STA group when necessary.
Data extracted from medical records included demographic characteristics, baseline ophthalmic findings, best-corrected visual acuity (BCVA), OCT parameters, follow-up clinical assessments, recurrence episodes, requirement for rescue therapy, and ocular or systemic adverse events. The primary outcome measure was control of ocular inflammation at three months following initiation of therapy. Secondary outcome measures included longitudinal changes in BCVA, OCT-based anatomical recovery, recurrence of inflammation, need for additional treatment, and treatment-related adverse events during follow-up.
Statistical analysis was planned using appropriate parametric or non-parametric tests for between-group comparisons, survival analysis methods for time-to-event outcomes, and a significance threshold of p < 0.05.
The study protocol was approved by the Institutional Review Board of the Faculty of Medicine, Benha University (Approval No. RC 11_1_2026). Due to the retrospective nature of the study, informed consent was waived. The study was conducted in accordance with the principles of the Declaration of Helsinki.
- Conditions
- VKH Syndrome
- Keywords
- Vogt-Koyanagi-Harada disease, acute uveitis, optical coherence tomography
- Medical subject headings
- Uveomeningoencephalitic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (%)
Measured: 3 months from treatment initiation
Secondary outcomes (3)
Change in Best-Corrected Visual Acuity (BCVA)
Change in BCVA measured in logarithm of the minimum angle of resolution (logMAR) units during follow-up.
Measured: Baseline, 1 month, 3 months, and 6 months
Resolution of Subretinal Fluid on Optical Coherence Tomography (OCT)
Presence or absence of subretinal fluid on OCT imaging during follow-up.
Measured: Baseline, 3 months, 6 months
Change in Central Macular Thickness (CMT)
Change in central macular thickness measured by OCT.
Measured: Baseline, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start1 Jan 2021
- Primary completion1 Oct 2025
- Study completion1 Dec 2025
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 VKH SyndromeStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ehab Mohamed Elsayed Mohamed Saad, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07405489
- Sponsor's protocol ID
- VKH Treatment
- Other IDs
- Benha University
- Acronym
- VKH-OC
- Status last verified
- Feb 2026
- First submitted
- 30 Jan 2026
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Saad EME, Abouelela MI, Elsayed MA. Short-term outcomes associated with oral prednisolone versus posterior sub-Tenon triamcinolone acetonide in acute ocular Vogt-Koyanagi-Harada disease. BMC Ophthalmol. 2026 Oct 24;26(1):685. doi: 10.1186/s12886-026-05448-7.
PubMed 42934593
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Comparative Cohort Study Evaluating the Efficacy, Anatomical Outcomes, Recurrence Rates, and Safety of Oral Prednisolone Versus Posterior Sub-Tenon Triamcinolone Acetonide as Initial Therapy in Acute Ocular Vogt-Koyanagi-Harada Disease
- ClinicalTrials.gov ID
- NCT07405489
- Acronym / sponsor ID
- VKH-OC / VKH Treatment
- Conditions
- VKH Syndrome
- Keywords
- Vogt-Koyanagi-Harada disease, acute uveitis, optical coherence tomography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 12 Feb 2026 (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.
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.
Detailed description
This retrospective comparative observational cohort study evaluated the efficacy and safety of oral prednisolone versus posterior sub-Tenon triamcinolone acetonide (PST/STA) as initial therapy for acute ocular Vogt-Koyanagi-Harada (VKH) disease. The study was conducted at the Ophthalmology Department, Faculty of Medicine, Benha University, Egypt, through a review of electronic and paper-based medical records of patients treated between January 2021 and December 2025.
Eligible patients were adults diagnosed with acute ocular VKH disease who had not received prior systemic or periocular corticosteroid therapy and who had a minimum follow-up duration of six months. Patients were managed according to routine clinical practice and received either systemic oral prednisolone or PST/STA as initial treatment, based on treating physician discretion. Both eyes of each patient were treated using the same modality, and analyses were performed at the patient level.
Patients in the oral prednisolone group received an initial dose of approximately 1 mg/kg/day (maximum 80 mg/day), followed by gradual tapering over 3-6 weeks. Patients in the PST/STA group received a posterior sub-Tenon injection of triamcinolone acetonide (40 mg/1 mL), with repeat injection considered if clinically indicated. Topical corticosteroids and cycloplegics were permitted in both groups. Systemic corticosteroids were reserved as rescue therapy in the PST/STA group when necessary.
Data extracted from medical records included demographic characteristics, baseline ophthalmic findings, best-corrected visual acuity (BCVA), OCT parameters, follow-up clinical assessments, recurrence episodes, requirement for rescue therapy, and ocular or systemic adverse events. The primary outcome measure was control of ocular inflammation at three months following initiation of therapy. Secondary outcome measures included longitudinal changes in BCVA, OCT-based anatomical recovery, recurrence of inflammation, need for additional treatment, and treatment-related adverse events during follow-up.
Statistical analysis was planned using appropriate parametric or non-parametric tests for between-group comparisons, survival analysis methods for time-to-event outcomes, and a significance threshold of p < 0.05.
The study protocol was approved by the Institutional Review Board of the Faculty of Medicine, Benha University (Approval No. RC 11_1_2026). Due to the retrospective nature of the study, informed consent was waived. The study was conducted in accordance with the principles of the Declaration of Helsinki.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of Participants Achieving Complete Control of Ocular Inflammation at 3 Months
Time frame: 3 months from treatment initiation
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 secondary outcomes
Change in Best-Corrected Visual Acuity (BCVA)
Time frame: Baseline, 1 month, 3 months, and 6 months
Resolution of Subretinal Fluid on Optical Coherence Tomography (OCT)
Time frame: Baseline, 3 months, 6 months
Change in Central Macular Thickness (CMT)
Time frame: Baseline, 3 months, and 6 months
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 12 Feb 2026.
- Derived from this study: PubMed 42934593Saad EME, Abouelela MI, Elsayed MA. Short-term outcomes associated with oral prednisolone versus posterior sub-Tenon triamcinolone acetonide in acute ocular Vogt-Koyanagi-Harada disease. BMC Ophthalmol. 2026 Oct 24;26(1):685. doi: 10.1186/s12886-026-05448-7.
Related trials for VKH Syndrome
Recruiting
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 VKH Syndrome, run by Benha University at 1 site in Egypt.
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 5 inclusion and 5 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 12 Feb 2026. 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 Egypt. 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?
Proportion of Participants Achieving Complete Control of Ocular Inflammation at 3 Months (time frame: 3 months from treatment initiation). 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 NCT07405489, 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 12 Feb 2026.