NCT01138657: VISUAL l

A Multicenter Study of the Efficacy and Safety of the Human Anti-TNF Monoclonal Antibody Adalimumab as Maintenance Therapy in Subjects Requiring High Dose Corticosteroids for Active Non-infectious Intermediate Uveitis, Posterior Uveitis, or Panuveitis - Including a Sub-study in Japanese Patients

Completed Phase 3 Results posted Last updated 2 July 2021

What this trial tests

Phase 3 trial testing Adalimumab in Uveitis in 239 participants. Completed in 1 August 2014.

Timeline

1 August 2010

Primary endpoint
1 July 2014

1 August 2014

Quick facts

Lead sponsor	AbbVie (prior sponsor, Abbott)
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	239
Start date	1 August 2010
Primary completion	1 July 2014
Estimated completion	1 August 2014

Drugs / interventions tested

• Adalimumab (ADALIMUMAB) — full drug profile →
• Prednisone (prednisone) — full drug profile →
• Placebo

Conditions studied

• Uveitis — all drugs for Uveitis →

Sponsor

AbbVie (prior sponsor, Abbott) — full company profile →

Who can join

18 and older, any sex, with Uveitis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Time to Treatment Failure on or After Week 6
  Time frame: From Baseline until end of study (up to 80 weeks)
  Time to treatment failure was analyzed using Kaplan-Meier methods. Treatment failures on or after Week 6 were counted as events. Dropouts for reasons other than treatment failure at any time during the study were censored at the dropout date. To be considered a treatment failure, ≥ 1 of these criteria had to be present in at least 1 eye: * New active, inflammatory chorioretinal or retinal vascula

Sponsor's own description

A study comparing the safety and efficacy of adalimumab compared with placebo in patients with active uveitis.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Adalimumab in Patients with Active Noninfectious Uveitis.
   Jaffe GJ, Dick AD, Brézin AP, Nguyen QD, et al · · 2016 · cited 455× · PMID 27602665 · DOI 10.1056/nejmoa1509852
2. Effect of Adalimumab on Visual Functioning in Patients With Noninfectious Intermediate Uveitis, Posterior Uveitis, and Panuveitis in the VISUAL-1 and VISUAL-2 Trials.
   Sheppard J, Joshi A, Betts KA, Hudgens S, et al · · 2017 · cited 56× · PMID 28426849 · DOI 10.1001/jamaophthalmol.2017.0603
3. Association of Disorganization of Retinal Inner Layers With Visual Acuity In Eyes With Uveitic Cystoid Macular Edema.
   Grewal DS, O'Sullivan ML, Kron M, Jaffe GJ. · · 2017 · cited 49× · PMID 28237411 · DOI 10.1016/j.ajo.2017.02.017
4. Adalimumab in Active and Inactive, Non-Infectious Uveitis: Global Results from the VISUAL I and VISUAL II Trials.
   Goto H, Zako M, Namba K, Hashida N, et al · · 2019 · cited 21× · PMID 30015528 · DOI 10.1080/09273948.2018.1491605
5. A Review of the Landscape of Targeted Immunomodulatory Therapies for Non-Infectious Uveitis.
   Sharma SM, Fu DJ, Xue K. · · 2018 · cited 9× · PMID 29189960 · DOI 10.1007/s40123-017-0115-5
6. Biosimilars in Adult and Pediatric Noninfectious Uveitis.
   Ploeger CG, Carvalho Soares Valentim C, Guner ME, Kabaalioglu Guner M. · · 2026 · PMID 41891092 · DOI 10.2147/opth.s553857
7. Pharmacotherapy for non-infectious uveitis: spotlight on phase III clinical trials of locally injected or implanted therapeutics and systemic immunomodulatory drugs.
   Shields MK, Ferreira LB, Ali SB, Dedina L, et al · · 2025 · PMID 40473986 · DOI 10.1186/s12348-025-00502-9