We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of the Long-term Safety and Efficacy of Adalimumab in Subjects With Intermediate-, Posterior-, or Pan-uveitis (VISUAL III)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01148225
First Posted: June 22, 2010
Last Update Posted: October 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
  Purpose
There is an unmet medical need in non-infectious intermediate-, posterior- and pan uveitis. These types of uveitis are at a higher risk for vision loss compared to anterior uveitis. Patients with these types of uveitis are often treated with chronic corticosteroids. The use of chronic corticosteroids is linked with predictable long-term side effects. The objective of this study is to evaluate the long term efficacy and safety of adalimumab subjects with non-infectious intermediate-, posterior- or pan-uveitis.

Condition Intervention Phase
Uveitis Drug: adalimumab Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Open-Label Study of the Long-term Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Non-infectious Intermediate-, Posterior-, or Pan-uveitis

Resource links provided by NLM:


Further study details as provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):

Primary Outcome Measures:
  • Evaluation of Adverse Events [ Time Frame: Baseline to Final Visit (Final Visit could occur at any point up to 330 weeks) ]
  • Significant laboratory value changes [ Time Frame: Baseline to Final Visit (Final Visit could occur at any point up to 330 weeks) ]
  • Significant vital sign changes [ Time Frame: Baseline to Final Visit (Final Visit could occur at any point up to 330 weeks) ]

Secondary Outcome Measures:
  • Proportion of subjects at each study time point with no new active, inflammatory chorioretinal or inflammatory retinal vascular lesion in both eyes relative to Baseline for subjects who had inactive uveitis when they entered the study. [ Time Frame: Final Visit (Final Visit could occur at any point up to 330 weeks) ]
  • Proportion of subjects at each study time point with no new active, inflammatory chorioretinal or inflammatory retinal vascular lesion in both eyes relative to Week 8 for subjects who had active uveitis when they entered the study. [ Time Frame: Final Visit (Final Visit could occur at any point up to 330 weeks) ]
  • Proportion of subjects at each study time point with a Grade <= 0.5+ in AC cells in both eyes on Slit Lamp Exam according to SUN criteria. [ Time Frame: Final Visit (Final Visit could occur at any point up to 330 weeks) ]
  • Proportion of subjects at each study time point with a Grade <= 0.5+ in vitreous haze in both eyes on indirect ophthalmoscopy according to NEI/SUN criteria. [ Time Frame: Final Visit (Final Visit could occur at any point up to 330 weeks) ]
  • Proportion of subjects at each study time point without a worsening of BCVA by >= 15 letters on the ETDRS in both eyes relative to Baseline for subjects who had inactive uveitis when they entered the study. [ Time Frame: Final Visit (Final Visit could occur at any point up to 330 weeks) ]
  • Proportion of subjects at each study time point without a worsening of BCVA by >= 15 letters on the ETDRS in both eyes relative to Week 8 for subjects who had active uveitis when they entered the study. [ Time Frame: Final Visit (Final Visit could occur at any point up to 330 weeks) ]
  • Percent change in central retinal thickness (1 mm subfield) in each eye at each study time point relative to Baseline for subjects who had inactive uveitis when they entered the study. [ Time Frame: Baseline to Final Visit (Final Visit could occur at any point up to 330 weeks) ]
  • Percent change in central retinal thickness (1 mm subfield) in each eye at each study time point relative to Week 8 for subjects who had active uveitis when they entered the study. [ Time Frame: Week 8 to Final Visit (Final Visit could occur at any point up to 330 weeks) ]
  • Change in NEI Visual Functioning Questionnaire (VFQ-25) score at each study time point relative to Baseline for subjects who had inactive uveitis when they entered the study. [ Time Frame: Baseline to Final Visit (Final Visit could occur at any point up to 330 weeks) ]
  • Change in NEI Visual Functioning Questionnaire (VFQ-25) score at each study time point relative to week 8 for subjects who had active uveitis when they entered the study. [ Time Frame: Week 8 to Final Visit (Final Visit could occur at any point up to 330 weeks) ]
  • Proportion of subjects at each study time point achieving a >= 50% reduction in immunosuppression load relative to Baseline for subjects who had inactive uveitis when they entered the study. [ Time Frame: Final Visit (Final Visit could occur at any point up to 330 weeks) ]
  • Proportion of subjects at each study time point achieving a >= 50% reduction in immunosuppression load relative to Week 8 for subjects who had active uveitis when they entered the study. [ Time Frame: Final Visit (Final Visit could occur at any point up to 330 weeks) ]

Estimated Enrollment: 424
Study Start Date: November 23, 2010
Estimated Study Completion Date: May 10, 2018
Estimated Primary Completion Date: March 31, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
adalimumab

This study is a Phase 3, open-label multicenter study designed to evaluate long-term safety and efficacy of adalimumab in adult subjects with non-infectious intermediate-, posterior-, or pan-uveitis who have either discontinued from study M10-877 or M10-880 for having met "Treatment Failure" criteria or have successfully completed study M10-877 or M10-880.

Starting at Baseline, all subjects will receive open label adalimumab 40 mg eow SC regardless of treatment assignment in the randomized, double-masked studies M10-877 or M10-880.

Drug: adalimumab
This study is a Phase 3, open-label multicenter study designed to evaluate long-term safety and efficacy of adalimumab in adult subjects with non-infectious intermediate-, posterior-, or pan-uveitis who have either discontinued from study M10-877 or M10-880 for having met "Treatment Failure" criteria or have successfully completed study M10-877 or M10-880.
Other Names:
  • ABT-D2E7
  • Humira

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject must have successfully enrolled in either study M10-877 or M10-880 and either met the endpoint of "Treatment Failure" or completed the study

Exclusion Criteria:

  • A subject will be excluded from this study if the patient discontinued from study M10-877 or M10-880 for any reasons other than having a Treatment Failure event
  • Subject with corneal or lens opacity that precludes visualization of the fundus or that likely requires cataract surgery during the duration of the trial
  • Subjects with intraocular pressure of >= 25 mmHg and on >= 2 glaucoma medications or evidence of glaucomatous optic nerve injury
  • Subject with proliferative or severe non-proliferative diabetic retinopathy or clinically significant macular edema due to diabetic retinopathy
  • Subject with neovascular/wet age-related macular degeneration
  • Subject with abnormality of vitreo-retinal interface (i.e., vitreomacular traction, epiretinal membranes, etc.) with the potential for macular structural damage independent of the inflammatory process
  • Subject with a systemic inflammatory disease that requires therapy with a prohibited immunosuppressive agent at the time of study entry
  Contacts and Locations
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): NCT01148225


  Hide Study Locations
Locations
United States, California
Retina Vitreous Associates Medical Group /ID# 49744
Beverly Hills, California, United States, 90211
United States, Florida
Dr. Andrew Gardner Logan, Tamarac, FL /ID# 58303
Tamarac, Florida, United States, 33321
Perez & Perez, MDs PA /ID# 26184
Tampa, Florida, United States, 33603
United States, Georgia
Emory University Hospital /ID# 25651
Atlanta, Georgia, United States, 30322
United States, Illinois
Northwestern University /ID# 86513
Chicago, Illinois, United States, 60611
Rush University Medical Center /ID# 25642
Chicago, Illinois, United States, 60612
United States, Maine
Ellsworth Uveitis & Retina Care /ID# 37133
Ellsworth, Maine, United States, 04605
United States, Maryland
Johns Hopkins University School of Medicine /ID# 75445
Baltimore, Maryland, United States, 21287
Wilmer Eye Institute /ID# 25643
Baltimore, Maryland, United States, 21287
United States, Michigan
Kresge Eye Institute /ID# 25645
Detroit, Michigan, United States, 48201
United States, New Jersey
Metropolitan Eye Research and Surgery Institute /ID# 25630
Palisades Park, New Jersey, United States, 07650
United States, New York
New York Eye and Ear Infirmary of Mount Sinai /ID# 25635
New York, New York, United States, 10003
Weill Cornell Medical College of Cornell University /ID# 108339
New York, New York, United States, 10021
United States, North Carolina
Duke Eye Center /ID# 26725
Durham, North Carolina, United States, 27705
Wake Forest Baptist Health Eye Center /ID# 63245
Winston-Salem, North Carolina, United States, 27157
United States, Oklahoma
Dean McGee Eye Institute /ID# 25652
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Oregon Health & Science University (OHSU) /ID# 25653
Portland, Oregon, United States, 97239
United States, Texas
Texas Retina Associates /ID# 27404
Dallas, Texas, United States, 75231
Houston Eye Associates /ID# 25657
Houston, Texas, United States, 77025
Retina Consultants of Houston /ID# 25637
Houston, Texas, United States, 77030
Valley Retina Institute, P.A. /ID# 81175
McAllen, Texas, United States, 78503
Foresight Studies, LLC /ID# 25648
San Antonio, Texas, United States, 78240
United States, Utah
University of Utah /ID# 25656
Salt Lake City, Utah, United States, 84132
United States, Virginia
Virginia Eye Consultants /ID# 25649
Norfolk, Virginia, United States, 23502
United States, West Virginia
West Virginia University Eye Institute /ID# 97497
Morgantown, West Virginia, United States, 26506
Argentina
Hospital Universitario Austral /ID# 71313
Buenos Aires, Argentina, B1629ODT
Organizacion Medica de Investigacion S.A. (OMI) /ID# 71296
Buenos Aires, Argentina, C1015ABO
OFTALMOS Instituto Oftalmológico de Buenos Aires /ID# 75259
Buenos Aires, Argentina, C1120AAN
Grupo Laser Vision /ID# 75260
Rosario, Argentina, S2000DFA
Australia
Royal Victorian Eye and Ear Hospital /ID# 25846
East Melbourne, Australia, 3002
The Lions Eye Institute /ID# 25848
Nedlands, Australia, 6009
Austria
Retina Center Vienna /ID# 25849
Vienna, Austria, 1030
Belgium
University Hospital Ghent, UZ Ghent /ID# 25853
Ghent, Belgium, 9000
Universitair Ziekenhuis Leuven /ID# 25854
Leuven, Belgium, 3000
Brazil
Universidade Federal de Sao Paulo - Hosp Sao Paulo (UNIFESP) /ID# 76455
Sao Paulo, Brazil, 04023-062
Canada
Southern Alberta Eye Center /ID# 26024
Calgary, Canada, T2H 0C8
Ivey Eye Institute /ID# 26023
London, Canada, N5A 4V2
Hospital Maisonneuve-Rosemont /ID# 26018
Montreal, Canada, H1T 2M4
Royal Victoria Hospital-MUHC /ID# 26019
Montreal, Canada, H3A 1A1
University of Ottawa Health Services /ID# 47400
Ottawa, Canada, K1H 8L6
VCHA/UBC Eye Care Centre /ID# 77944
Vancouver, Canada, V5Z 0E9
St. Paul's Hospital /ID# 82675
Vancouver, Canada, V6Z 1Y6
Czechia
Vseobecna fakultni nemocnice /ID# 25856
Prague 2, Czechia, 128 00
Denmark
Aarhus University Hospital /ID# 25858
Aarhus, Denmark, 8000
Glostrup University Hospital, Rigshospitalet /ID# 25857
Glostrup, Denmark, 2600
France
CHU de Nantes, Hotel Dieu - HME /ID# 25866
Nantes Cedex 1, France, 44093
Groupe Hospitalier Cochin /ID# 25860
Paris Cedex 14, France, 75679
CHNO des Quinze-Vingts /ID# 97937
Paris, France, 75012
Germany
Medizinische Universitaetsklinik /ID# 25869
Freiburg, Germany, 79106
Interdisziplinaeres Uveitiszentrum Heidelberg /ID# 25868
Heidelberg, Germany, 69120
Universitaetsklinikum Schleswig-Holstein /ID# 76755
Kiel, Germany, 24105
St. Franziskus Hospital Muenster /ID# 25867
Muenster, Germany, 48145
Klinikum der Universitaet Munich /ID# 72278
Munich, Germany, 80336
Greece
Interbalkan Medical Center /ID# 74641
Thessaloniki, Greece, 57001
Israel
Rabin Medical Center /ID# 25873
Petah Tikva, Israel, 49100
The Tel Aviv Sourasky MC /ID# 25876
Tel Aviv, Israel, 64239
Italy
AO Universitaria Bologna, Policlinico S. Orsola Malpighi /ID# 78355
Bologna, Italy, 40138
Ospedale San Raffaele /ID# 25879
Milan, Italy, 20132
Ospedale Sacro Cuore /ID# 47964
Negrar (Verona), Italy, 37024
Azienda Ospedaliera Arcispedale S. Maria Nuova /I.R.C.C.S /ID# 71855
Reggio Emilia, Italy, 42100
Sapienza Universita di Roma /ID# 25878
Rome, Italy, 00161
Japan
Kyushu University Hospital /ID# 26345
Fukuoka-shi, Japan
Aichi Medical University Hospital /ID# 88039
Nagakute-shi, Japan
Hokkaido University Hospital /ID# 26338
Sapporo-shi, Hokkaido, Japan
Tohoku University Hospital /ID# 29753
Sendai-shi, Japan
Tokyo Medical University Hospital /ID# 26341
Shinjuku-ku, Tokyo, Japan
Osaka University Graduate School of Medicine /ID# 26344
Suita-shi, Japan
Medical Hospital of Tokyo Medical and Dental University /ID# 26340
Tokyo, Japan
The University of Tokyo Hospital /ID# 26339
Tokyo, Japan
Yamaguchi University Hospital /ID# 88041
Yamaguchi, Ube, Japan
Yokohama Municipal Citizen's Hospital /ID# 26343
Yokohama-shi, Japan
Mexico
Asociacion para Evitar la Ceguera en Mexico I.A.P. /ID# 71555
Mexico DF, Mexico, 04030
CODET Vision Institute /ID# 71295
Tijuana, Mexico, 22320
Poland
Optimum Profesorskie Centrum Okulistyki /ID# 74815
Gdansk-Chelm, Poland, 80-809
Uniwersytecki Szpital Kliniczny im Jana Mikulicza-Radeckiego /ID# 74818
Wroclaw, Poland, 50-556
Portugal
Centro Hospitalar e Universitario de Coimbra, EPE /ID# 25883
Coimbra, Portugal, 3000-075
Spain
Hospital Clinic de Barcelona /ID# 25884
Barcelona, Spain, 08028
Hospital General Universitario de Valencia /ID# 25887
Valencia, Spain, 46014
IOBA - Instituto Universitario de Oftalmobiologia Aplicada /ID# 25890
Valladolid, Spain, 47011
Switzerland
Lindenhofspital Bern /ID# 75615
Bern, Switzerland, CH-3012
Hopital Ophtalmique Jules Gonin /ID# 75235
Lausanne, Switzerland, 1004
United Kingdom
University of Aberdeen /ID# 25895
Aberdeen, United Kingdom, AB25 2ZD
Bristol Eye Hospital /ID# 25894
Bristol, United Kingdom, BS1 2LX
Royal Liverpool and Broadgreen Univ Hospitals NHS Trust /ID# 73356
Liverpool, United Kingdom, L7 8XP
Moorfields Eye Hospital /ID# 25896
London, United Kingdom, EC1V 2PD
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Steven Jungerwirth, MD AbbVie
  More Information

Additional Information:
Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT01148225     History of Changes
Other Study ID Numbers: M11-327
2009-016196-29 ( EudraCT Number )
First Submitted: May 14, 2010
First Posted: June 22, 2010
Last Update Posted: October 9, 2017
Last Verified: October 2017

Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):
Non-infectious Uveitis
Active Uveitis
Posterior-Uveitis
Uveitis
Pan-uveitis
Intermediate-Uveitis

Additional relevant MeSH terms:
Uveitis
Panuveitis
Uveal Diseases
Eye Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents