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NCT01526889 · ClinicalTrials.gov registry record · Phase 2
Safety,Tolerability and Efficacy of Intravitreal LFG316 in Patients With Active Non-infectious Intermediate-, posterior-or Panuveitis ,
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
NCT01526889: Completed Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT01526889 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 25 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01526889, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
Study 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.
Primary Outcome
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
Interventions
- DRUG LFG316
- DRUG Conventional Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2012-12-20 |
| Est. Completion | 2017-08-24 |
| Phase | Phase 2 |
What the finished NCT01526889 record still lists
NCT01526889 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 2 interventions - of which LFG316 is the first listed.
NCT01526889 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01526889 about?
NCT01526889 is a clinical study titled "Safety,Tolerability and Efficacy of Intravitreal LFG316 in Patients With Active Non-infectious Intermediate-, posterior-or Panuveitis ,". 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...
What is the current status of trial NCT01526889?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2012-12-20. Estimated completion is 2017-08-24.
What interventions are being tested in trial NCT01526889?
The interventions under investigation include: LFG316 (DRUG), Conventional Therapy (DRUG).
Who is sponsoring clinical trial NCT01526889?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01526889's enrollment target sits among peer trials
25 1719th of 2000 higher than 245 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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