Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01527500 · ClinicalTrials.gov registry record · Phase 2
Intravitreal LFG316 in Patients With Age-related Macular Degeneration (AMD)
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 158
- Enrollment target
NCT01527500 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 158 participants.
The verdict
NCT01527500, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 158 participants
- Enrollment target
Study Summary
This study was conducted in two parts; Part A and Part B: Part B was initially planned to include two cohorts. Cohort 2 was cancelled following an interim analysis for efficacy in Part A of the study, and not due to any safety issues or concerns. Cohort 2 is not referred to again and part B cohort 1 is referred to as part B alone in the remainder of the document and is the subject of this report. Part B was conducted to assess the safety and tolerability of a single intravitreal (IVT) LFG316 10 mg/100 µL injection. There was no efficacy evaluation in Part B. The study employed a multicenter, randomized, sham - controlled, single masked design. Eight patients with advanced AMD were planned to be randomized in a 3:1 ratio to receive a single IVT dose of LFG316 (10 mg/100 µL) or sham injection. Patients assigned to a sham injection were treated the same as those assigned to LFG316, except that the hub of an empty syringe (without needle) was placed against the eye instead of the IVT injection.
Interventions
- DRUG Sham
- DRUG LFG316
- DRUG LFG316 Lower dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 158 participants |
| Start Date | 2012-01-25 |
| Est. Completion | 2015-06-24 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01527500
The ClinicalTrials.gov registry entry for NCT01527500 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 158 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Sham is the first listed.
NCT01527500 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01527500 about?
NCT01527500 is a clinical study titled "Intravitreal LFG316 in Patients With Age-related Macular Degeneration (AMD)". This study was conducted in two parts; Part A and Part B: Part B was initially planned to include two cohorts. Cohort 2 was cancelled following an interim analysis for efficacy in Part A of the study, and not due to any safety issues or concerns. Cohort 2 is not referred to again and part B cohort 1...
What is the current status of trial NCT01527500?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 158 participants. The study started on 2012-01-25. Estimated completion is 2015-06-24.
What interventions are being tested in trial NCT01527500?
The interventions under investigation include: Sham (DRUG), LFG316 (DRUG), LFG316 Lower dose (DRUG).
Who is sponsoring clinical trial NCT01527500?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.