Phase 2
N=25
Safety,Tolerability and Efficacy of Intravitreal LFG316 in Patients With Active Non-infectious Intermediate-, posterior-or Panuveitis ,
Non-infectious Intermediate Uveitis · Non-infectious Posterior Uveitis · Non-infectious Panuveitis
Bottom Line
View on ClinicalTrials.gov: NCT01526889 ↗Enrolled (actual)
25
Serious AEs
4.0%
Results posted
Oct 2018
Primary outcome: Primary: Number of Participants With Response Rate for the Individual Response Criteria - in the Study Eye — 3; 3; 0; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- LFG316 (Drug); Conventional Therapy (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Feb 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Response Rate for the Individual Response Criteria - in the Study Eye |
3; 3; 0; 1; 0; 0 | — |
| PRIMARY Number of Participants With Remission in Study Eye - Treatment Period |
2; 0 | — |
| SECONDARY Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period |
0; 0; 2; 1; 10; 4 | — |
| SECONDARY Mean Best Corrected Visual Acuity (BCVA) in Study Eye - Treatment Period |
72.5; 76.1; 80.5; 79.0; 68.8; 78.9 | — |
| SECONDARY Number of Patients With Macular Edema in Study Eye - Treatment Period |
2; 1; 1; 1; 3; 0 | — |
| SECONDARY Number of Patients With Chorioretinal Lesions in Study Eye - Treatment Period |
3; 0; 2; 0; 4; 0 | — |
| SECONDARY Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period |
2; 0; 4; 1; 1; 0 | — |
| SECONDARY Number of Participants With or Without Anti-LFG316 Antibodies |
3; 12; 3; 10; 2; 9 | — |
| SECONDARY Mean Percent Change in Total C5 Concentrations in Serum - Treatment Period |
6.80; 1.02; 8.21; -1.27; 10.6; -8.33 | — |
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.
Eligibility Criteria
Key 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 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.
Key Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01526889). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.