Safety, Tolerability and Efficacy of Intravitreal LFG316 in Patients With Multifocal Choroiditis and Panuveitis (MCP)

This study is currently recruiting participants.
Verified January 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01526889
First received: February 1, 2012
Last updated: January 17, 2014
Last verified: January 2014
  Purpose

This study will assess the safety, tolerability and effect of intravitreal LFG316 in patients with active Multifocal Choroiditis and Panuveitis.


Condition Intervention Phase
Multifocal Choroiditis
Panuveitis
Active Vitritis
Drug: LFG316
Drug: Conventional Therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
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 Multifocal Choroiditis (MFC)

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Number of patients with a clinical response rate [ Time Frame: Screening and Day 29 ] [ Designated as safety issue: No ]
    Clinical response rate is defined by any one of the following criteria 1) An improvement of 2 or more steps in vitreous haze, improvement in visual acuity (10 or more letters) or improvement of choroidal neovascular macular edema using dilated ophthalmoscopy and/or fluorescein angiography.


Secondary Outcome Measures:
  • Change in vitritis [ Time Frame: Baseline, Day 15, 29, 43, 57 and/or 85 ] [ Designated as safety issue: No ]
    Change in vitritis will be measured using the standardized vitreous haze score (Nussenblatt)

  • Change in visual acuity [ Time Frame: Baseline, Day 15, 29, 43, 57 and/or 85 ] [ Designated as safety issue: No ]
    Visual acuity will be measured using Early Treatment Diabetic Retinopathy Study (ETDRS) eye charts under ETDRS conditions.

  • Number of patients with adverse events [ Time Frame: Day 85 ] [ Designated as safety issue: Yes ]
    Adverse events will be determined based on descriptive analyses of vital signs, ECG evaluation, and clinical safety laboratory evaluations.

  • Serum versus time concentrations of LFG316 [ Time Frame: Days1-85 ] [ Designated as safety issue: No ]
    Blood will be collected at each visit for the determination of drug serum concentrations following the intravitreal doses.


Estimated Enrollment: 24
Study Start Date: October 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LFG316 -Intravitreal Injection Drug: LFG316
LFG316 5 mg administered via IVT (intravitreally) on Days 1 29 and 57.
Placebo Comparator: Conventional Therapy Drug: Conventional Therapy
Conventional Therapy will be administered in accordance with its prescribing info.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Active Multifocal Choroiditis and Panuveitis in the study eye
  • Vitritis in the study eye of 2+ or more (on Nussenblatt scale)
  • Visual acuity (ETDRS Method) of 60 letters or less in the study eye.
  • For females: Must not be pregnant or lactating and must, unless post-menopausal, use effective contraception in accordance with Women of Childbearing Potential policy.

Exclusion Criteria:

  • Substantial abnormality in screening laboratory results or electrocardiogram.
  • History of infectious uveitis or endophthalmitis in either eye
  • Media opacity in the study eye that would interfere with study conduct
  Contacts and Locations
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, Connecticut
Novartis Investigative Site Recruiting
New Haven, Connecticut, United States
United States, Massachusetts
Novartis Investigative Site Not yet recruiting
Cambridge, Massachusetts, United States, 02142
United States, Ohio
Novartis Investigative Site Not yet recruiting
Cleveland, Ohio, United States, 44195
United Kingdom
Novartis Investigative Site Not yet recruiting
Bristol, United Kingdom, BS1 2LX
Novartis Investigative Site Not yet 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: January 17, 2014
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:
Multifocal Choroiditis
Panuveitis
Vitritis
Visual Acuity
Vitreous Haze
Choroidal Neovascularization

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

ClinicalTrials.gov processed this record on April 17, 2014