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

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ClinicalTrials.gov Identifier: NCT02620618
Recruitment Status : Completed
First Posted : December 3, 2015
Last Update Posted : December 3, 2015
Sponsor:
Information provided by (Responsible Party):
Tamer Ahmed Macky, Cairo University

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.


Condition or disease Intervention/treatment Phase
Behçet's Disease Uveitis Drug: Intravitreal Infliximab Phase 1 Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intravitreal Infliximab in Refractory Uveitis in Behcet's Disease: A Safety and Efficacy Clinical Study
Study Start Date : January 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014


Arm Intervention/treatment
Experimental: Intravitreal Infliximab
Patients with refractory behcets uveitis.
Drug: Intravitreal Infliximab
ocular safety and efficacy in treating inflammation in uveitis patients with Behcets Disease
Other Name: Intravitreal TNF alpha




Primary Outcome Measures :
  1. Best Corrected Visual Acuity in logMAR [ Time Frame: 18 weeks ]
  2. Central Foveal Thickness in microns by Optical Coherence Tomography [ Time Frame: 18 weeks ]
  3. Electroretinogram a and b waves amplitudes in microvolts [ Time Frame: 18 weeks ]
  4. Vitritis severity graded 0-3 [ Time Frame: 18 weeks ]
  5. Electroretinogram a and b waves implicit times in milliseconds [ Time Frame: 18 weeks ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

Refractory posterior uveitis in patients with Behçet's disease.

Exclusion criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02620618


Sponsors and Collaborators
Cairo University
Investigators
Study Chair: Mahmoud Soliman, MD PhD Cairo University

Responsible Party: Tamer Ahmed Macky, Professor, Cairo University
ClinicalTrials.gov Identifier: NCT02620618     History of Changes
Other Study ID Numbers: Intravitreal Infliximab
First Posted: December 3, 2015    Key Record Dates
Last Update Posted: December 3, 2015
Last Verified: December 2015

Keywords provided by Tamer Ahmed Macky, Cairo University:
Safety
Efficacy
intravitreal infliximab
ocular behcets
refractory posterior uveitis

Additional relevant MeSH terms:
Behcet Syndrome
Uveitis
Uveal Diseases
Eye Diseases
Mouth Diseases
Stomatognathic Diseases
Uveitis, Anterior
Panuveitis
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Hereditary Autoinflammatory Diseases
Genetic Diseases, Inborn
Skin Diseases, Genetic
Skin Diseases
Skin Diseases, Vascular
Infliximab
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents