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

• Status: Unknown status
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rafic Hariri University Hospital
• Collaborator: American University of Beirut Medical Center
• Treatments: Adalimumab

Criteria

Inclusion Criteria:

• Ability to provide written informed consent and comply with study assessments for the full duration of the study

• Age > 17 years

• Patients with active choroidal neovascularization, diabetic retinopathy, or uveitis in the study eye which did not improve with conventional therapy

• Best corrected visual acuity of 20/70 or less.

Exclusion Criteria:

• Are participating in another clinical study requiring follow up examinations

• Have received any other experimental drug within 12 weeks prior to enrollment

• Are unwilling or unable to follow or comply with all study-related procedures

• Inability to obtain photographs, fluorescein angiography, or optical coherence tomography to document CNV, e.g. due to media opacity, allergy to fluorescein dye or lack of venous access

• Aphakia or pseudophakia with the absence of posterior capsule (unless it resulted from a yttrium aluminum garner [YAG]) posterior capsulotomy)

• Within two months prior to screening, have had intraocular surgery (including cataract surgery) in the study eye

• Within 1 month prior to screening had YAG laser in the study eye

• Have had intravitreal anti VEGF or intravitreal steroids in the last 6 weeks

• Have had previous pars plana vitrectomy in the study eye

• Are pregnant or are trying to become pregnant

• Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated