Intravitreal LFG316 in Patients With Age-related Macular Degeneration (AMD)
Completed · Phase 2 · Has a placebo group
Conditions studied: Geographic Atrophy, Age-related Macular Degeneration
In brief
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.
Key facts
- Study ID
- NCT01527500
- Run by
- Novartis Pharmaceuticals
- People needed
- 158
- Starts
- 2012-01-25
- Expected to finish
- 2015-06-24
- Last updated by the study team
- 2021-01-05
Who can join
Age: 55 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis of AMD if enrolled in Part B of study
- Geographic atrophy in at least one eye if enrolled in Part A of study
- ETDRS best corrected visual acuity of 60 letters or worse (\~≤ 20/63)
You may not qualify if…
- Retinal disease other than AMD
- History of choroidal neovascularization
- Severe cataract
- History of infectious uveitis or endophthalmitis
- Eye surgery in the non-study eye within 30 days prior to study
- Eye surgery or IVT injection in the study eye within 90 days prior to study
- Other protocol-defined inclusion/exclusion criteria may apply
Where it is running
- Novartis Investigative Site — Phoenix, Arizona, United States
- Novartis Investigative Site — Phoenix, Arizona, United States
- Novartis Investigative Site — Tucson, Arizona, United States
- Novartis Investigative Site — Beverly Hills, California, United States
- Novartis Investigative Site — Pasadena, California, United States
- Novartis Investigative Site — Sacramento, California, United States
- Novartis Investigative Site — Colorado Springs, Colorado, United States
- Novartis Investigative Site — Fort Myers, Florida, United States
- Novartis Investigative Site — Miami, Florida, United States
- Novartis Investigative Site — Winter Haven, Florida, United States
- Novartis Investigative Site — Atlanta, Georgia, United States
- Novartis Investigative Site — Leawood, Kansas, United States
- Novartis Investigative Site — Boston, Massachusetts, United States
- Novartis Investigative Site — Grand Rapids, Michigan, United States
- Novartis Investigative Site — Jackson, Michigan, United States
- Novartis Investigative Site — Charlotte, North Carolina, United States
- Novartis Investigative Site — Cincinnati, Ohio, United States
- Novartis Investigative Site — Cleveland, Ohio, United States
- Novartis Investigative Site — Silverdale, Washington, United States
Full record on ClinicalTrials.gov
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