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CompletedNCT00615693Updated Dec 22, 2020

Safety, Tolerability, and Efficacy of AEB071 in the Treatment of Uveitis

A Phase 2 interventional study of AEB071 in Uveitis, Posterior Uveitis and Panuveitis, sponsored by Novartis. Completed at 13 sites in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-12-22.

Primary conditionUveitis, PosteriorRegistry: UveitisReclassifiedWhy we changed it
Registry
Uveitis — the first condition term the registry derived for this study.
ClinicalTrials.gg
Uveitis, Posterior
Why
  1. The study's listed conditions name Uveitis, Posterior, a narrower term within Uveitis.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Novartis · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
13
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study summary

The purpose of this study is to assess the safety, tolerability, and efficacy of AEB071 as a therapy for uveitis. Vision improvement and reduction in the swelling of retina will be measured for the assessment of efficacy.

02

Conditions studied

  • Uveitis
  • Posterior Uveitis
  • Panuveitis

Browse trials for

Keywords

  • Uveitis
  • Macular Edema
03

In context

Uveitis, Posterior Reclassified

61 studies on the registry are indexed under Uveitis, Posterior; 4 are open to participants now.

This study's enrollment of 13 is below the median of 37 across 45 interventional studies indexed under Uveitis, Posterior.

Browse Uveitis, Posterior studies →

Lead sponsor

Novartis is the lead sponsor of 714 studies on the registry; none are open to participants now.

Browse Novartis studies →

Compared within Uveitis, Posterior, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Uveitis. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male and female patients with non-infectious intermediate or posterior uveitis or panuveitis in at least one eye, age 18 to 70 years of age inclusive, who are otherwise in good health
  • Macular edema with average central retinal thickness ≥ 250 µm
  • A vitreous haze score ≥ 1, but ≤ 3 (based on the National Eye Institute grading system)
  • Best Corrected Visual Acuity no worse than 20/400 and no better than 20/40
  • Daily prednisone dose \< 1 mg/kg

Exclusion criteria

Exclusion Criteria:

  • Patients with choroidal neovascularization.

  • Patients with the following forms of uveitis:

    1. Serpiginous choroidopathy
    2. Acute multifocal placoid pigment epitheliopathy
    3. White dot retino-choroidopathies (e.g., multiple evanescent white dot syndrome (MEWDS) or multifocal choroiditis)
  • Macular edema associated with other ocular disease (e.g., diabetic retinopathy)
  • Patients who had a prior vitrectomy
  • Any eye condition that may affect the evaluation of visual acuity and retinal thickness
  • Concurrent use of certain agents (specific for different agents are defined in the protocol)
  • Use of systemic medications known to be toxic to the lens, retina, or optic nerve (e.g. deferoxamine, chloroquine, and ethambutol) currently or in the past 6 months
  • Other protocol-defined inclusion/exclusion criteria may apply
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
13 participants (actual)

Study arms

  • Experimental
    1

    Drug: AEB071

Interventions

06

What researchers measure

Primary outcomes

  1. Safety and tolerability of AEB071

    Time frame: Baseline/Day 1 to Week 8 (Day 56) (end of study)

Secondary outcomes

  1. Change in the degree of inflammation in the study eye

    Time frame: Baseline/Day 1, Week 8 (Day 56)/end of study

  2. Change in the visual acuity of the study eye

    Time frame: Baseline/Day 1, Week 8 (Day 56)/end of study

  3. Change in macular edema in the study eye

    Time frame: Baseline/Day 1, Week 8 (Day 56)/end of study

07

Study locations

13 sites
  • University of Southern California Doheny Eye Institute
    Los Angeles, California 90033, United States
  • University of California
    San Francisco, California 94143, United States
  • Colorado Retina Associates
    Denver, Colorado 80230, United States
  • University of Miami Miller School of Medicine; Anne Bates Leach Eye Hosptial;Bascom Palmer Eye Institute
    Miami, Florida 33136, United States
  • University of South Florida, Eye Institute
    Tampa, Florida 33612, United States
  • Emory University
    Atlanta, Georgia 30322, United States
  • John Hopkins Hospital/Wilmer Eye Institute
    Baltimore, Maryland 21287, United States
  • MERSI
    Cambridge, Massachusetts 02142, United States
  • Mayo Clinic Department of Opthalmology
    Rochester, Minnesota 55905, United States
  • Cornea and Laser Eye Institute
    Teaneck, New Jersey 07666, United States
  • New York Eye and Ear Infirmary, Clinical Research Department
    New York, New York 10003, United States
  • Retina Research Centre
    Austin, Texas 78705, United States
  • Vitreoretinal Consultants
    Houston, Texas 77030, United States
08

References and documents

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 2008 and a primary completion of Oct 2009. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 1, 2008
First posted
Feb 14, 2008
Start
Jul 2008
Primary completionActual
Oct 2009
Results delay requested
Aug 20, 2020
Last update
Dec 22, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 22, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00615693
Lead sponsor
Novartis
Responsible party
Sponsor
First posted
Feb 14, 2008
Start date
Jul 2008
Primary completion
Oct 2009
Last update
Dec 22, 2020

Study contacts

Novartis
principal investigator · Novartis investigator site

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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