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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)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01148225
First received: May 14, 2010
Last updated: April 19, 2017
Last verified: April 2017
May 14, 2010
April 19, 2017
November 23, 2010
March 31, 2018   (Final data collection date for primary outcome measure)
  • 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) ]
  • Evaluation of Adverse Events [ Time Frame: Baseline to Final Visit (Final Visit could occur at any point up to 78 weeks) ]
  • Significant laboratory value changes [ Time Frame: Baseline to Final Visit (Final Visit could occur at any point up to 78 weeks) ]
  • Significant vital sign changes [ Time Frame: Baseline to Final Visit (Final Visit could occur at any point up to 78 weeks) ]
Complete list of historical versions of study NCT01148225 on ClinicalTrials.gov Archive Site
  • 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 282 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) ]
  • Proportion of subjects 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 any time up to 78 weeks) ]
  • Proportion of subjects 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 any time up to 78 weeks) ]
  • Proportion of subjects 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 78 weeks) ]
  • Proportion of subjects without a worsening of BCVA by >= 3 lines or 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 any time up to 78 weeks) ]
  • 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 any time up to 78 weeks) ]
  • Change in NEI Visual Functioning Questionnaire (VFQ-25) score 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 78 weeks) ]
  • Proportion of subjects 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 78 weeks) ]
  • Proportion of subjects 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 (Final Visit could occur at any point up to 78 weeks) ]
  • Proportion of subjects without a worsening of BCVA by >= 3 lines or 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 (Final Visit could occur at any point up to 78 weeks) ]
  • 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 (Final Visit could occur at any point up to 78 weeks) ]
  • Proportion of subjects 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 any time up to 78 weeks) ]
  • Change in NEI Visual Functioning Questionnaire (VFQ-25) score relative to Baseline 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 78 weeks) ]
Not Provided
Not Provided
 
A Study of the Long-term Safety and Efficacy of Adalimumab in Subjects With Intermediate-, Posterior-, or Pan-uveitis
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
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.
Not Provided
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Uveitis
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
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.

Intervention: Drug: adalimumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
424
May 10, 2018
March 31, 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 99 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Australia,   Austria,   Belgium,   Brazil,   Canada,   Czechia,   Denmark,   France,   Germany,   Greece,   Israel,   Italy,   Japan,   Mexico,   Poland,   Portugal,   Spain,   Switzerland,   United Kingdom,   United States
Czech Republic
 
NCT01148225
M11-327
2009-016196-29 ( EudraCT Number )
Yes
Not Provided
Not Provided
Not Provided
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Not Provided
Study Director: Steven Jungerwirth, MD AbbVie
AbbVie
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP