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CompletedNCT00404742LUMINATEUpdated Jun 22, 2012

A Study of LX211 in Clinically Quiescent Non-infectious Intermediate, Anterior and Intermediate, Posterior or Pan-Uveitis

A Phase 3 interventional study of Placebo and LX211 in Uveitis, Posterior, Uveitis, Intermediate and Panuveitis, sponsored by Lux Biosciences, Inc.. Completed at 41 sites in 7 countries. Open to participants aged 13 Years and older. Per ClinicalTrials.gov, last updated 2012-06-22.

Sponsored by Lux Biosciences, Inc. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
232
Allocation
Randomized
Ages
13 Years and older
Sex
All
01

Study summary

The objective of this study is to evaluate the safety and efficacy of LX211 as therapy in subjects with clinically quiescent non-infectious uveitis

02

Conditions studied

  • Uveitis, Posterior
  • Uveitis, Intermediate
  • Panuveitis

Keywords

  • uveitis
  • calcineurin
03

In context

Uveitis, Posterior

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

This study's enrollment of 232 is above the median of 37 across 45 interventional studies indexed under Uveitis, Posterior.

Browse Uveitis, Posterior studies →

Lead sponsor

Lux Biosciences, Inc. is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years and older
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

  • A documented history of non-infectious intermediate, anterior and intermediate, posterior or panuveitis.
  • Minimum prescribed therapy upon enrollment is one or more of the following:

    • systemic prednisone or equivalent averaging ≥ 10 mg/day
    • at least 2 periocular/intravitreal administrations for control of inflammatory disease within the previous 8 months (but not within 6 weeks of randomization).
    • at least one, but not more than 2 drugs from among the following compounds: cyclosporine, tacrolimus, azathioprine, mycophenolate mofetil, methotrexate
  • Subjects with clinically quiescent uveitis in both eyes at enrollment and who have been on a stable treatment regimen for a minimum of 6 weeks
  • Best-corrected distance visual acuity in the worst involved eye of 20/400 or better (ETDRS logMAR \<1.34)
  • Subjects not planning to undergo elective ocular surgery during the study

Exclusion criteria

Exclusion Criteria:

  • Evidence of active, uncontrolled non-infectious uveitis
  • Periocular administration of within the previous 6 weeks.
  • Uveitis of infectious etiology
  • Uncontrolled glaucoma
  • Clinically suspected or confirmed central nervous system or ocular lymphoma
  • History or diagnosis of Behçet's disease
  • Primary diagnosis of anterior uveitis
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.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

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.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
232 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Drug: Placebo

  • Active comparator
    LX211, 0.2 mg/kg

    Drug: LX211

  • Active comparator
    LX211, 0.4 mg/kg

    Drug: LX211

  • Active comparator
    LX211, 0.6 mg/kg

    Drug: LX211

Interventions

  • DrugPlacebo

    PO BID

  • DrugLX211

    0.2 mg/kg, twice a day (BID)

  • DrugLX211

    0.4 mg/kg, twice a day (BID)

  • DrugLX211

    0.6 mg/kg, twice a day (BID)

06

What researchers measure

Primary outcomes

  1. recurrence of ocular inflammation

    Time frame: 26 weeks

Secondary outcomes

  1. BCVA

    Time frame: 26 weeks

  2. systemic corticosteroid usage

    Time frame: 26 weeks

07

Study locations

41 sites
  • University of Alabama at Birmingham
    Birmingham, Alabama, United States
  • Retinal Consultants of Arizona
    Phoenix, Arizona 85014, United States
  • University of Illinois - Chicago
    Chicago, Illinois 60612, United States
  • Midwest Eye Institute
    Indianapolis, Indiana 46280, United States
  • Wilmer Eye Institute
    Baltimore, Maryland, United States
  • Massachusetts Eye and Ear Infirmary
    Boston, Massachusetts, United States
  • Massachusetts Eye Research and Surgery Institute
    Cambridge, Massachusetts 02142, United States
  • Associated Retinal Consultants, PC
    Grand Rapids, Michigan 49546, United States
  • Tauber Eye Center
    Kansas City, Missouri 64111, United States
  • UMDNJ-New Jersey Medical School, Ophthalmology Dept.
    Newark, New Jersey 07103, United States
  • New York Eye & Ear Hospital
    New York, New York 10003, United States
  • Duke University Eye Center, Erwin Road
    Durham, North Carolina, United States
  • Oregon Health Sciences University
    Portland, Oregon 97201, United States
  • Texas Retina Associates
    Arlington, Texas 76012, United States
  • Brian B. Berger, MD, P.A.
    Austin, Texas 78705, United States
  • Texas Retina Associates
    Dallas, Texas 75231, United States
  • Vitreoretinal Consultants
    Houston, Texas 77030, United States
  • Retina & Uveitis Consultants of Texas
    San Antonio, Texas 78240, United States
  • Viginia Eye Consultants
    Norfolk, Virginia 23502, United States
  • Universitätsklinik für Augenheilkunde
    Salzburg, Austria
  • Klinik für Augenheilkunde, Dept. of Ophthalmology
    Wien, Austria
  • Ivey Eye Institute
    London, Ontario N6A 4G5, Canada
  • University of Ottawa Eye Institute
    Ottawa, Ontario K1H 8L6, Canada
  • McGill University Health Center
    Montreal, Quebec H3A 1A1, Canada
  • Center Hospitalier Universitaire d' Angers, Service d'Opthalmologie
    Angers, France
  • Hôpital Pitié Salpétrière, Service d'Ophtalmologie
    Paris, France
  • Universitätsklinikum Freiburg
    Freiburg, Germany
  • Augenklinik der Universität Heidelberg
    Heidelberg, Germany
  • Universitätsklinikum Tübingen
    Tübingen, Germany
  • L V Prasad Eye Institute
    Hyderabaad, Andhra Pradesh, India
  • Consultant, Retina and Vitreous Services, Bhubaneswar L V Prasad Eye Institute
    Bhubaneswar, Orissa, India
  • Department of Opthalmology, Sankara Nethralaya, Medical Research Foundation,
    Chennai, Tamil Nadu, India
  • Aravind Eye Hospitals and Postgraduate Institute of Ophthalmology
    Madurai, Tamil Nadu, India
  • Vittala International Institute of Ophthalmology
    Bangalore, India
  • Advanced Eye Centre, Postgraduate Institute of Medical Education and Research (PGIMER)
    Chandigarh, India
  • Aravind Eye Hospital, Uvea Clinic
    Coimbatore, India
  • Aditya Jyot Eye Hospital Pvt Ltd
    Mumbai, India
  • Dr. R. P. Centre for Ophthalmic Sciences, All India Institute of Medical Sciences
    New Delhi, India
  • Bristol Eye Hospital and University of Bristol
    Bristol, United Kingdom
  • Royal Liverpool University Hospital
    Liverpool, United Kingdom
  • Moorfields Eye Hospital
    London, United Kingdom
08

References and documents

Related links

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 22, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00404742
Lead sponsor
Lux Biosciences, Inc.
Responsible party
Sponsor
First posted
Nov 29, 2006
Start date
Jan 2007
Primary completion
Nov 2008
Completion
May 2009
Last update
Jun 22, 2012

Study contacts

Eddy Anglade, M.D.
study chair · Chief Medical Officer

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.

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