NCT01306955

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 Phase 4 Last updated 1 March 2011

What this trial tests

Phase 4 trial testing methylorednisolone in Behcet's Disease in 34 participants. Status unknown.

Timeline

1 February 2010

Primary endpoint
1 July 2011

1 August 2011

Quick facts

Lead sponsor	Tehran University of Medical Sciences
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	34
Start date	1 February 2010
Primary completion	1 July 2011
Estimated completion	1 August 2011
Sites	1 location across Iran

Drugs / interventions tested

• methylorednisolone — full drug profile →
• dextrose water 5%

Conditions studied

• Behcet's Disease — all drugs for Behcet's Disease →

Sponsor

Tehran University of Medical Sciences

Who can join

Adults 10 to 70, any sex, with Behcet's Disease. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

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

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.