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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 October 2016 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01526889
First received: February 1, 2012
Last updated: October 26, 2016
Last verified: October 2016
  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.

Patients responding to treatment will be offered up to 6 months of extended tretment Assessments for safety will include laboratory safety tests, ECGs, physical exams, ocular exams, vital signs and the monitoring of adverse events.

Study participation may vary from a minimum of 3 months to a maximum of 9 months


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: October 2012
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: February 2017 (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.

Detailed Description:

Approximately 24 patients with active non-infectious uveitis, in at least one eye, requiring intensification of systemic immunosuppressive therapy will be enrolled and randomized to receive intravitreal LFG316 or conventional therapy (investigator's discretion). Only one eye (the study eye) will be treated with LFG316 and the other eye (fellow eye) will be treated at the investigator's discretion.Throughout the study, the fellow eye may be treated as needed; except that certain systemic medications are prohibited There will be 1 screening and 8 scheduled visits over 85 days for a total of 9 site visits for all patients.

At Day 85, patients receiving LFG316 treatment who meet the criteria for a 'responder', will be offered an additional 6 months of LFG316 treatment on a PRN basis. Additional 3 scheduled visits will be attended by LFG316-responder patients during the extension period. However, patients can have unscheduled visits as needed and as determined by the investigator. Safety evaluation and ocular assessments will be performed throughout the study duration.

Patients in the treatment extension phase, who experience a flare post their last dose and require treatment, may receive a dose of LFG316. These patients will be assessed for a response at their next PRN visit as scheduled by the investigator. Visit frequency is determined by the investigator. If they continue to respond to LFG316 therapy, they may remain in the PRN treatment arm. They may receive up to 7 additional doses of LFG316 in the PRN period. Throughout the trial LFG316 will not be administered more frequently than monthly.

Patients in the extension phase, who discontinue treatment prematurely will be asked to return approximately 1 month after their last dose.

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 which may change.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female patients 18 years or older
  • Active NIU, in at least one eye, as defined below, in patients requiring intensification of systemic immunosuppressive therapy;
  • Vitreous haze at least 1+ on the scale of Nussenblatt et al 1985,or
  • Chorioretinal lesions due to uveitis (chorioretinal lesions due to infectious uveitis will exclude the patient)
  • Patients who present with a flare and who are at the time of the enrollment on systemic corticosteroid or non-steroidal immunosuppressants will have their therapy tapered or stopped, respectively, at the time of intravitreal LFG316 administration.

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.
  • History of infectious uveitis or endophthalmitis in either eye.
  • History of retinal detachment
  • 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, Georgia
Novartis Investigative Site Recruiting
Marietta, Georgia, United States, 30060
United States, Massachusetts
Novartis Investigative Site Recruiting
Cambridge, Massachusetts, United States, 02142
United States, Nebraska
Novartis Investigative Site Recruiting
Omaha, Nebraska, United States, 68198-5540
United States, New Jersey
Novartis Investigative Site Active, not recruiting
Teaneck, New Jersey, United States, 07666
United States, Texas
Novartis Investigative Site Recruiting
Houston, Texas, United States, 77030
United Kingdom
Novartis Investigative Site Recruiting
Birmingham, United Kingdom, B15 2TH
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

Responsible Party: 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: October 26, 2016
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

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

ClinicalTrials.gov processed this record on December 06, 2016