Intravitreal Adalimumab in Refractory Diabetic Retinopathy, Choroidal Neovascularization or Uveitis: A Pilot Study

Sponsor
Rafic Hariri University Hospital
Study ID
NCT00855608
Phase
PHASE1
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
17 Years - 88 Years
Healthy Volunteers
Not accepted

Interventions

  • adalimumab — DRUG
    intravitreal adalimumab injection 0.03 ml in volume (1.5mg) one dose to one eye

Study Details

Direct intravitreal administration of medication is the preferred method of treatment for uveitis and retinal vascular disorders. The eye is a self contained organ relatively isolated from the systemic circulation by the tight blood retinal barrier. Effective intraocular drug levels can be achieved with a much smaller amount of medication if injected intravitreally and this also results in minimal systemic exposure to the patient. Preliminary studies have shown that adalimumab may have a positive role in the management of uveitis in humans and can be an effective treatment intravitreally in animal models. No data has been published yet on intravitreal use of adalimumab in human subjects.

Key Dates

Start date
Mar 31, 2009
Status verified
Sep 2009
Primary completion
Mar 31, 2013
Completion
Mar 31, 2013

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: adalimumab arm
    intravitreal mode of delivery

Primary Outcome Measure

The main outcome measure will be visual acuity improvement (3 lines) [ Time Frame: 6 weeks ]

Central Contacts

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