Safety,Tolerability and Efficacy of Intravitreal LFG316 in Patients With Active Non-infectious Intermediate-, posterior-or Panuveitis ,

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2015 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01526889
First received: February 1, 2012
Last updated: May 28, 2015
Last verified: May 2015
  Purpose

This is a multi-center, randomized, active-controlled, open-label study. Approximately 24 patients with active, non-infectious intermediate-, posterior-, or panuveitis requiring systemic immunosuppressive therapy will be enrolled.

Safety, efficacy, and PK assessments will occur at scheduled visits over a 12-week period. Low-molecular-weight non-steroidal immunosuppressive medications are allowed up to the baseline day as long as the dose has not changed in the 3 weeks prior to baseline, except for corticosteroid doses for which may change.

Assessments for safety will include laboratory safety tests, physical exams, ocular exams, vital signs and the monitoring of adverse events.


Condition Intervention Phase
Non-infectious Intermediate Uveitis
Non-infectious Posterior Uveitis
Non-infectious Panuveitis
Drug: LFG316
Drug: Conventional Therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Active-controlled, Open-label, Multicenter proof-of Concept Study of Intravitreal LFG316 in Patients With Active Non-infectious Intermediate-, Posterior-, or Panuveitis Requiring Systemic Immunosuppressive Therapy

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Clinical activity / efficacy [ Time Frame: Through end of study ] [ Designated as safety issue: No ]
    Vitreous haze will be assessed in masked manner to evaluate the clinical activity of LFG316


Secondary Outcome Measures:
  • Visual acuity [ Time Frame: Through end of study ] [ Designated as safety issue: No ]
    Visual acuity will be measured using Early Treatment Diabetic Retinopathy Study (ETDRS) eye charts under ETDRS conditions.

  • Safety [ Time Frame: Through end of study ] [ Designated as safety issue: Yes ]
    Comprehensive assessment of clinical and ocular safety including adverse events will be collected

  • Pharmacokinetics [ Time Frame: Through end of study ] [ Designated as safety issue: No ]
    Blood will be collected at each visit for the profiling of serum drug concentrations.


Estimated Enrollment: 24
Study Start Date: December 2011
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LFG316 -Intravitreal Injection Drug: LFG316
LFG316 administered intravitreally (IVT)
Active Comparator: Conventional Therapy Drug: Conventional Therapy
Conventional Therapy administered in accordance with its prescribing info.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female patients 18 years or older with active uveitic disease (flare) in study eye.
  • Visual acuity (ETDRS method) of 20 letters (20/400 Snellen equivalent) or better in the study eye.
  • For female patients, must not be pregnant or lactating and must, unless post-menopausal, use effective contraception.
  • Ability to provide informed consent and comply with the protocol.

Exclusion Criteria:

  • Uveitis so severe that, in the investigator's judgment, it is too risky to test an experimental drug
  • Any biologic immunosuppressive agent given via intravitreal, intravenous or subcutaneous route within 4-12 months depending on the agent.
  • Any intraocular surgery, intravitreal injection, periocular injection, or laser photocoagulation to the study eye within 90 days prior to dosing.
  • In the study eye, cataract expected to interfere with study conduct or require surgery during the study.
  • Forms of uveitis that may spontaneously resolve
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01526889

Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals

Locations
United States, Colorado
Novartis Investigative Site Recruiting
Golden, Colorado, United States, 80401
United States, Connecticut
Novartis Investigative Site Not yet recruiting
Hartford, Connecticut, United States, 06106
Novartis Investigative Site Withdrawn
New Haven, Connecticut, United States
United States, Georgia
Novartis Investigative Site Not yet recruiting
Marietta, Georgia, United States, 30060
United States, Massachusetts
Novartis Investigative Site Recruiting
Cambridge, Massachusetts, United States, 02142
United States, New Jersey
Novartis Investigative Site Recruiting
Teaneck, New Jersey, United States, 07666
United States, Ohio
Novartis Investigative Site Withdrawn
Cleveland, Ohio, United States, 44195
United States, Texas
Novartis Investigative Site Recruiting
Houston, Texas, United States, 77030
United Kingdom
Novartis Investigative Site Recruiting
Bristol, United Kingdom, BS1 2LX
Novartis Investigative Site Recruiting
London, United Kingdom, EC1V 2PD
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01526889     History of Changes
Other Study ID Numbers: CLFG316A2204, 2011-003254-90
Study First Received: February 1, 2012
Last Updated: May 28, 2015
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:
Non-infectious uveitis
Panuveitis
Vitreous haze
Visual acuity
Vitreous Haze

Additional relevant MeSH terms:
Choroiditis
Panuveitis
Pars Planitis
Uveitis
Uveitis, Intermediate
Uveitis, Posterior
Choroid Diseases
Eye Diseases
Uveal Diseases

ClinicalTrials.gov processed this record on September 03, 2015