Intravitreal LFG316 in Patients With Age-related Macular Degeneration (AMD)
Public ClinicalTrials.gov record NCT01527500. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Randomized, Sham-control, Proof-of-concept Study of Intravitreal LFG316 in Patients With Geographic Atrophy Associated With Age-related Macular Degeneration
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01527500
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 158 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 55 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 25, 2012 (Actual)
- Primary completion
- Jun 24, 2015 (Actual)
- Completion
- Jun 24, 2015 (Actual)
- Last update posted
- Jan 5, 2021
2012 – 2015
United States locations
- U.S. sites
- 19
- U.S. states
- 11
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Novartis Investigative Site | Phoenix | Arizona | 85014 | — |
| Novartis Investigative Site | Phoenix | Arizona | 85020 | — |
| Novartis Investigative Site | Tucson | Arizona | 85704-5614 | — |
| Novartis Investigative Site | Beverly Hills | California | 90211 | — |
| Novartis Investigative Site | Pasadena | California | 91105-3153 | — |
| Novartis Investigative Site | Sacramento | California | 95841 | — |
| Novartis Investigative Site | Colorado Springs | Colorado | 80909 | — |
| Novartis Investigative Site | Fort Myers | Florida | 33912-7125 | — |
| Novartis Investigative Site | Miami | Florida | 33143 | — |
| Novartis Investigative Site | Winter Haven | Florida | 33880 | — |
| Novartis Investigative Site | Atlanta | Georgia | 30342 | — |
| Novartis Investigative Site | Leawood | Kansas | 66211 | — |
| Novartis Investigative Site | Boston | Massachusetts | 02114 | — |
| Novartis Investigative Site | Grand Rapids | Michigan | 49546 | — |
| Novartis Investigative Site | Jackson | Michigan | 49202 | — |
| Novartis Investigative Site | Charlotte | North Carolina | 28210 | — |
| Novartis Investigative Site | Cincinnati | Ohio | 45242 | — |
| Novartis Investigative Site | Cleveland | Ohio | 44122 | — |
| Novartis Investigative Site | Silverdale | Washington | 98383 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01527500, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 5, 2021 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01527500 live on ClinicalTrials.gov.