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

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ClinicalTrials.gov Identifier: NCT01148225
Recruitment Status : Completed
First Posted : June 22, 2010
Last Update Posted : April 6, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
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 or disease Intervention/treatment Phase
Uveitis Drug: adalimumab Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 424 participants
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
Actual Study Start Date : November 23, 2010
Actual Primary Completion Date : March 15, 2018
Actual Study Completion Date : March 15, 2018


Arm Intervention/treatment
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



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

Secondary Outcome Measures :
  1. 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) ]
  2. 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) ]
  3. 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) ]
  4. 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) ]
  5. 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) ]
  6. 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) ]
  7. 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) ]
  8. 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) ]
  9. 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) ]
  10. 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) ]
  11. 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) ]
  12. 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) ]


Information from the National Library of Medicine

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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

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 Assoc Med Grp
Beverly Hills, California, United States, 90211
United States, Florida
Dr. Andrew Gardner Logan, FL
Tamarac, Florida, United States, 33321
Perez & Perez, MDs PA
Tampa, Florida, United States, 33603
United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30322
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611-2927
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Maine
Ellsworth Uveitis & Retina Car
Ellsworth, Maine, United States, 04605
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
United States, Michigan
Kresge Eye Institute
Detroit, Michigan, United States, 48201
United States, New Jersey
Metro Eye Res and Surgery Inst
Palisades Park, New Jersey, United States, 07650
United States, New York
New York Eye and Ear Infirmary
New York, New York, United States, 10003
Columbia Univ Medical Center
New York, New York, United States, 10032-3725
United States, North Carolina
Duke Univ Med Ctr
Durham, North Carolina, United States, 27710
Wake Forest Univ HS
Winston-Salem, North Carolina, United States, 27157
United States, Oklahoma
Dean McGee Eye Institute
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239-3098
United States, Texas
Texas Retina Associates
Dallas, Texas, United States, 75231
Houston Eye Associates
Houston, Texas, United States, 77025
Retina Consultants of Houston
Houston, Texas, United States, 77030
Valley Retina Institute, P.A.
McAllen, Texas, United States, 78503
Foresight Studies, LLC
San Antonio, Texas, United States, 78240
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84112-5500
United States, Virginia
Virginia Eye Consultants
Norfolk, Virginia, United States, 23502
United States, West Virginia
West Virginia Univ School Med
Morgantown, West Virginia, United States, 26506
Argentina
OFTALMOS Inst Oftalmológico
Buenos Aires, Argentina, 1120
Org Medica de Investigacion
Buenos Aires, Argentina, C1015ABO
Hospital Universitario Austral
Pilar, Argentina, 1629
Grupo Laser Vision
Santa Fe, Argentina, 2000
Australia, Victoria
Royal Victorian Eye & Ear Hosp
East Melbourne, Victoria, Australia, 3002
Australia, Western Australia
The Lions Eye Institute
Nedlands, Western Australia, Australia, 6009
Austria
Retina Center Vienna
Vienna, Austria, 1030
Belgium
UZ Gent
Gent, Oost-Vlaanderen, Belgium, 9000
UZ Leuven
Leuven, Belgium, 3000
Brazil
Univ Fed Sao Paulo (UNIFESP)
Sao Paulo, Brazil, 04024-002
Canada, Alberta
Southern Alberta Eye Center
Calgary, Alberta, Canada, T2H 0C8
Canada, British Columbia
Univ British Columbia
Vancouver, British Columbia, Canada, V5Z 4E8
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
Canada, Ontario
Ivey Eye Institute
London, Ontario, Canada, N6A 4V2
Univ of Ottawa
Ottawa, Ontario, Canada, K1N 6N5
Canada, Quebec
Hospital Maisonneuve-Rosemont
Montreal, Quebec, Canada, H1T 2M4
McGill Univ HC
Montreal, Quebec, Canada, H3G 1A4
Czechia
Vseobecna Fakultni Nemocnice
Prague, Czechia, 128 08
Denmark
Aarhus University Hospital
Aarhus C, Midtjylland, Denmark, 8000
Glostrup Univ Hospital
Glostrup, Denmark, 2000
France
CHU de Nantes, Hotel Dieu -HME
Nantes, France, 44093
Groupe Hospitalier Cochin
Paris, France, 75014
CHNO des Quinze-Vingts
Paris, France, 75571
Germany
Universitaetsklinik Heidelberg
Heidelberg, Baden-Wurttemberg, Germany, 69120
Univ Hosp Schleswig-Holstein
Kiel, Schleswig-Holstein, Germany, 24105
Universitätsklinikum Freiburg
Freiburg, Germany, 79106
Klinikum der Univ Munich
Munich, Germany, 80337
St. Franziskus Hosp Muenster
Munster, Germany, 48145
Greece
Interbalkan Medical Center
Thessaloniki, Greece, 57001
Israel
Rabin Medical Center
Petakh Tikva, Tel-Aviv, Israel, 4941492
Tel Aviv Sourasky Medical Ctr
Tel Aviv-Yafo, Tel-Aviv, Israel, 6423906
Italy
A.O. Policlinico S. Orsola Malpighi
Bologna, Emilia-Romagna, Italy, 40138
AP Romano Umberto I
Rome, Lazio, Italy, 00161
Ospedale Classificato Equiparato Sacro Cuore-Don Calabria
Negrar, Verona, Italy, 37024
Ospedale San Raffaele IRCCS
Milan, Italy, 20132
Arcispedale S. Maria Nuova
Reggio Emilia, Italy, 42121
Japan
Aichi Medical University Hosp
Nagakute, Aichi, Japan, 4801195
Kyushu University Hospital
Fukuoka-shi, Fukuoka, Japan, 812-8582
Tohoku University Hospital
Sendai-shi, Miyagi, Japan, 980-8574
Osaka University Hospital
Suita-shi, Osaka, Japan, 565-0871
Medical Hospital of Tokyo Medical and Dental University
Bunkyo-ku, Tokyo, Japan, 113-8519
Tokyo Medical University Hosp
Shinjuku-ku, Tokyo, Japan, 160-0023
Hokkaido University Hospital
Sapporo, Japan, 060-8648
The University of Tokyo Hosp
Tokyo, Japan, 113-0033
Yamaguchi University Hospital
UBE, Japan, 755-0046
Yokohama Municipal Citizen's H
Yokohama, Japan, 236-0004
Mexico
Asoc. para Evitar la Ceguera MX IAP
Mexico City, Mexico, 04030
CODET Vision Institute
Tijuana, Mexico, 22320
Poland
Optimum Prof. Centr Okulistyki
Gdansk, Poland, 80-809
Uni Szpital Klin Jana Mikulicz
Wroclaw, Poland, 50-556
Portugal
Ctr Hosp Univ Coimbra, EPE
Coimbra, Portugal, 3000-075
Spain
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Hosp General Univ de Valencia
Valencia, Spain, 46014
IOBA - Inst Univ Oftalmobiolog
Valladolid, Spain, 47011
Switzerland
Lindenhofspital Bern
Bern, Switzerland, 3012
Hop Ophtalmique Jules Gonin
Lausanne, Switzerland, 1000
United Kingdom
University of Aberdeen
Aberdeen, United Kingdom, AB25 2ZD
Bristol Eye Hospital
Bristol, United Kingdom, BS1 2LX
Royal Liverpool and Broadgreen
Liverpool, United Kingdom, L7 8XP
Moorfields Eye Hospital
London, United Kingdom, EC1V 2PD
Sponsors and Collaborators
AbbVie
Investigators
Study Director: AbbVie Inc. AbbVie

Additional Information:
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT01148225     History of Changes
Other Study ID Numbers: M11-327
2009-016196-29 ( EudraCT Number )
First Posted: June 22, 2010    Key Record Dates
Last Update Posted: April 6, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by AbbVie:
Intermediate-Uveitis
Non-infectious Uveitis
Posterior-Uveitis
Active Uveitis
Pan-uveitis
Uveitis

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