Intravitreal Infliximab in Refractory Uveitis in Behcet's Disease: A Safety and Efficacy Clinical Study

NCT02620618 | Completed Phase 1 DMC

• 1 other identifier: Intravitreal Infliximab
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

Intravitreal injection of up to 2 mg of infliximab has proved to be safe in animal models (rabbits and primates). These studies have shown no evidence of intraocular inflammation or toxicity by clinical, electrophysiological, and histopathological examination for up to 90 days even with 3 repeated monthly injections. However, the study conducted by Rassi et al was the only one to report the development of severe intraocular inflammation in one eye out of 12 rabbit eyes at 90 days following 3 intravitreal injections (2mg monthly). Unfortunately, clinical studies conducted on patients, so far, have raised serious concern about its safety and adverse effects. These clinical studies have shown various and inconsistent results in terms of the safety and efficacy of intravitreal infliximab. These studies were conducted on patients with refractory as well as naïve cases of age related macular degenerations choroidal neovascularization (AMD CNV), diabetic macular edema (DME), central retinal vein occlusion (CRVO), angiomatous malformations, pseudophakic macular edema, and uveitis. The doses used ranged from 0.5mg to 2mg. The initial study by Theodossaidis et al in 2009 did not report any intraocular inflammation in 3 patients receiving 2 intravitreal injections of 1 and 2 mg for refractory AMD CNV with 7 months follow up period.(8) Later several clinical studies have reported severe intraocular inflammation following intravitreal injections of infliximab in non-uveitic patients.These collected data have initiated a call for cautious use of intravitreal infliximab. On the other hand, studies investigating intravitreal infliximab in uveitis patients have shown improvement in vision, reduction in macular thickness on optical coherence tomography (OCT), and reduction in inflammation. In this study, we have investigated the safety and efficacy of 3 consecutive intravitreal infliximab injections (1 mg/0.05 mL, 6 weeks apart) in carefully selected group of patients with refractory uveitis in Behcet's disease.

Conditions

Behçet's Disease; Uveitis

Keywords

Safety; Efficacy; intravitreal infliximab; ocular behcets; refractory posterior uveitis

Outcome Measures

Primary Outcomes (5)

• Best Corrected Visual Acuity in logMAR

  18 weeks

• Central Foveal Thickness in microns by Optical Coherence Tomography

  18 weeks

• Electroretinogram a and b waves amplitudes in microvolts

  18 weeks

• Vitritis severity graded 0-3

  18 weeks

• Electroretinogram a and b waves implicit times in milliseconds

  18 weeks

Study Arms (1)

Intravitreal Infliximab

EXPERIMENTAL

Patients with refractory behcets uveitis.

Drug: Intravitreal Infliximab

Interventions

Intravitreal Infliximab DRUG

ocular safety and efficacy in treating inflammation in uveitis patients with Behcets Disease

Also known as: Intravitreal TNF alpha

Intravitreal Infliximab

Eligibility Criteria

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

You may qualify if:

• Refractory posterior uveitis in patients with Behçet's disease.

You may not qualify if:

• Patients receiving or who had received systemic infliximab or other TNFα inhibitors
• Patients with uncontrolled systemic Behçet
• Patients who received previous intravitreal steroids (\< 6 months)
• Patients with severe media opacity
• Patients with previous history of ocular surgery other than cataract surgery
• Cataract surgery within the previous 6 months.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Behcet Syndrome; Uveitis; Uveitis, Posterior

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Uveitis, Anterior; Panuveitis; Uveal Diseases; Eye Diseases; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Hereditary Autoinflammatory Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vascular

Study Officials

• Mahmoud Soliman, MD PhD

  Cairo University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 26, 2015
• First Posted: December 3, 2015
• Study Start: January 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 3, 2015

Record last verified: 2015-12