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

NCT00855608 | Unknown Phase 1 DMC

• 1 other identifier: RHUH
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Uveitis; Diabetic Retinopathy; Choroidal Neovascularization

Keywords

choroidal neovascularization; diabetic retinopathy; uveitis; refractory cases of uveitis

Outcome Measures

Primary Outcomes (1)

• The main outcome measure will be visual acuity improvement (3 lines)

  6 weeks

Secondary Outcomes (1)

• central foveal thickness and angiographic lesion size

  6 weeks

Study Arms (1)

adalimumab arm

EXPERIMENTAL

intravitreal mode of delivery

Drug: adalimumab

Interventions

adalimumab DRUG

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

Also known as: Humira

adalimumab arm

Eligibility Criteria

• Age: 17 Years - 88 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rafic Hariri University Hospital: lead
• American University of Beirut Medical Center: collaborator

Study Sites (1)

Rafic Hariri University Hospital

Beirut, South Beirut, 1136044, Lebanon

RECRUITING

Related Publications (1)

• Theodossiadis PG, Liarakos VS, Sfikakis PP, Vergados IA, Theodossiadis GP. Intravitreal administration of the anti-tumor necrosis factor agent infliximab for neovascular age-related macular degeneration. Am J Ophthalmol. 2009 May;147(5):825-30, 830.e1. doi: 10.1016/j.ajo.2008.12.004. Epub 2009 Feb 10.

  PMID: 19211094 RESULT

MeSH Terms

Conditions

Uveitis; Diabetic Retinopathy; Choroidal Neovascularization

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases; Retinal Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Choroid Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• ahmad m mansour, md

  RHUH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ahmad m mansour, md

CONTACT

9611374625; dr.ahmad@cyberia.net.lb

george Mollayess, md

CONTACT

961350000; gm23@aub.edu.lb

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 2, 2009
• First Posted: March 4, 2009
• Study Start: March 1, 2009
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: July 22, 2011

Record last verified: 2009-09

Locations

LE (1)