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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: Completed Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT01527500 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 158 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (19% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Geographic atrophy (GA) lesion growth measured by fundus autofluorescence (FAF) from baseline to Day 505.
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 |
What the finished NCT01527500 record still lists
NCT01527500 is an interventional study that assigns participants to a tested intervention. The registered 158 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (19% higher).
The record links to 0 conditions, and to 3 interventions - of which Sham is the first listed.
NCT01527500 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT01527500's enrollment target sits among peer trials
158 443rd of 2000 higher than 1,558 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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