NCT01526889

Brief Summary

This was a multi-center, randomized, active-controlled, open-label study. Approximately 24 patients with active, non-infectious intermediate-, posterior-, or panuveitis requiring systemic immunosuppressive therapy were enrolled. Safety, efficacy, and PK assessments occurred at scheduled visits over a 12-week period. Low-molecular-weight non-steroidal immunosuppressive medications were allowed up to the baseline day as long as the dose had not changed in the 3 weeks prior to baseline, except for corticosteroid doses for which might have changed. Patients responding to treatment were offered up to 6 months of extended treatment. Assessments for safety included laboratory safety tests, ECGs, physical exams, ocular exams, vital signs and the monitoring of adverse events. Study participation varied from a minimum of 3 months to a maximum of 9 months.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2012

Longer than P75 for phase_2

Geographic Reach
2 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 6, 2012

Completed
11 months until next milestone

Study Start

First participant enrolled

December 20, 2012

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 16, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 24, 2017

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

October 31, 2018

Completed
Last Updated

January 5, 2021

Status Verified

October 1, 2018

Enrollment Period

4.2 years

First QC Date

February 1, 2012

Results QC Date

August 15, 2018

Last Update Submit

December 9, 2020

Conditions

Non-infectious Intermediate UveitisNon-infectious Posterior UveitisNon-infectious Panuveitis

Keywords

Non-infectious uveitisPanuveitisVisual acuityVitreous HazeInflammation of the uveainflammation of the middle, pigmented vascular structures of the eye, iris, ciliary body, choroid plexus

Outcome Measures

Primary Outcomes (2)

  • Number of Participants With Response Rate for the Individual Response Criteria - in the Study Eye

    Response rate as defined by: 1. An improvement of 2 or more steps in vitreous haze (scale of 0 to 4), relative to baseline OR 2. An improvement of 10 or more letters in visual acuity (VA), relative to baseline OR 3. An improvement of 2 or more steps in anterior chamber cells (ACC) score (scale of 0 to 4), relative to baseline OR 4. Absence of chorioretinal lesions as determined by the investigator

    Day 85 (end of study)

  • Number of Participants With Remission in Study Eye - Treatment Period

    Remission (complete response) was defined as any patient who had: * a vitreous haze score of 0 or 0.5 (scale of 0 to 4) in the study eye, AND * an anterior chamber cell score of 0 (scale of 0 to 4), AND * no chorioretinal lesions in the study eye, AND * was off all immune modulatory therapy (systemic, corticosteroids and topical), AND * without any worsening of uveitis during the trial.

    Day 85 (end of study)

Secondary Outcomes (7)

  • Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period

    Day 2, 8, 15, 29, 43, 57 and, 85 (end of the study)

  • Mean Best Corrected Visual Acuity (BCVA) in Study Eye - Treatment Period

    Day 2, 8, 15, 29, 43, 57 and, 85 (end of the study)

  • Number of Patients With Macular Edema in Study Eye - Treatment Period

    Day 85 (end of study)

  • Number of Patients With Chorioretinal Lesions in Study Eye - Treatment Period

    Day 2, 8, 15, 29, 43, 57 and, 85 (end of the study)

  • Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period

    Day 2, 8, 15, 29, 43, 57 and, 85 (end of the study)

  • +2 more secondary outcomes

Study Arms (2)

LFG316 -Intravitreal Injection

EXPERIMENTAL
Drug: LFG316

Conventional Therapy

ACTIVE COMPARATOR
Drug: Conventional Therapy

Interventions

LFG316DRUG

LFG316 administered intravitreally (IVT)

LFG316 -Intravitreal Injection
Conventional TherapyDRUG

Conventional Therapy administered in accordance with its prescribing info.

Conventional Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 excluded)
  • Patients with a flare and at the time of the enrollment on systemic corticosteroid or non-steroidal immunosuppressants had 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.

You may not qualify if:

  • Uveitis so severe that, in the investigator's judgment, it was 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 have spontaneously resolved

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Novartis Investigative Site

Golden, Colorado, 80401, United States

Location

Novartis Investigative Site

Marietta, Georgia, 30060, United States

Location

Novartis Investigative Site

Cambridge, Massachusetts, 02142, United States

Location

Novartis Investigative Site

Omaha, Nebraska, 68198-5540, United States

Location

Novartis Investigative Site

Teaneck, New Jersey, 07666, United States

Location

Novartis Investigative Site

Houston, Texas, 77030, United States

Location

Novartis Investigative Site

Bristol, BS1 2LX, United Kingdom

Location

Novartis Investigative Site

London, EC1V 2PD, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Panuveitis

Condition Hierarchy (Ancestors)

UveitisUveal DiseasesEye Diseases

Results Point of Contact

Title
Study Director
Organization
Novartis Pharmaceuticals
Novartis.email@novartis.com
+1 862-778-8300

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2012

First Posted

February 6, 2012

Study Start

December 20, 2012

Primary Completion

February 16, 2017

Study Completion

August 24, 2017

Last Updated

January 5, 2021

Results First Posted

October 31, 2018

Record last verified: 2018-10

Locations

GB(2)US(6)