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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, Older Adult)
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


  Show 84 Study Locations
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