The Efficacy of Methylprednisolone in the Treatment of Patients With Ocular Involvement in Behcet's Disease

The Efficacy of Intravenous Pulses of Methylprednisolone in the Treatment of Patients With Ocular Involvement in Behcet's Disease, a Double Blind Pilot Study

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01306955

Enrollment

Registered

2011-03-02

Start date

2010-02-28

Completion date

2011-08-31

Last updated

2011-03-02

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

Conditions

Behcet's Disease

Keywords

retinal vasculitis, posterior uveitis, methylprednisolone

Brief summary

The goal of this study is to examine the efficacy of 1gram/day intravenous pulses of methylprednisolone on 3 consecutive days in Behcet's patients with ocular involvement. A total of 34 Behcet's patients referring to Behcet's clinic in Shariati hospital whose problem was confirmed with new international criteria of Behcet's disease (ICBD) will be randomly assigned into one of the two equal groups of intervention or control. Behcet's patients are those with ocular involvement who were under the same cytotoxic treatment with cyclophosphamide and azathioprine. For the patients in the intervention group, intravenous infusion of 1000 mg methylprednisolone in 100cc D/w 5% or 100cc D/w5% on 3 consecutive days will be added to treatment diet. Then treatment will begin with oral prednisolone, 0.5 mg/kg. After that, all the patients were followed up with no other therapeutic intervention by study group. The patients will be visited every 2 months by an ophthalmologist and study group for 6 months in 3 settings. To estimate the ocular inflammation of patients, we use visual acuity, retinal and ocular posterior chamber inflammation index.

Interventions

DRUGmethylorednisolone

intravenous infusion of 1000 mg methylprednisolone in 100cc D/w 5% on 3 consecutive days at beginning of treatment

OTHERdextrose water 5%

intravenous infusion of 100cc D/w 5% on 3 consecutive days at beginning of treatment

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

10 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Diagnosed Behcet's disease according to international criteria * New or relapse of retinal vasculitis who received any cytotoxic or glucocorticoid since 2 months ago * New or relapse of severe posterior uveitis who are candidate for cyclophosphamide and azathioprine according to their physician

Exclusion criteria

* Not Signing the informed consent * Visual acuity lower than 1/10 by Snellen chart * Presence of infectious diseases such as TB * Presence of diabetes mellitus, hypertension, heart disease, liver disease, renal disease, or edema * Presence of other glucocorticoid consumption contraindications

Design outcomes

Primary

Measure	Time frame	Description
OCULAR IBDDAM INDEX	14 months	Iranian Behcet's disease Dynamic Activity measurement
VISUAL ACUITY	14	Check visual acuity with snellen chart by ophthalmologist

Secondary

Measure	Time frame	Description
Inflammation in retin	14	Check inflammation in retin by ophthalmologist
Inflammation in posterior chamber	14	Check inflammation in posterior uvea by ophthalmologist
inflammation in anterior chamber	14	check inflammation in anterior chamber by ophthalmologist

Countries

Iran

Contacts

Primary ContactFarhad Shahram, Professor

Shahramf@tums.ac.ir0098-21-8802-6956

Backup ContactMohammadi mastaneh, MD

Mastanehmohammadi88@gmale.com0098-21-8802-6956

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026