Phase 2
N=150
Intravitreal LFG316 in Patients With Age-related Macular Degeneration (AMD)
Geographic Atrophy · Age-related Macular Degeneration
Bottom Line
View on ClinicalTrials.gov: NCT01527500 ↗Enrolled (actual)
150
Serious AEs
24.7%
Results posted
Jul 2018
Primary outcome: Primary: Part A: Geographic Atrophy (GA) Lesion Growth Measured by Fundus Autofluorescence (FAF) From Baseline to Day 505 — 1.95; 1.58 mm^2
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- LFG316 (Drug); Sham (Drug); LFG316 Lower dose (Drug)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part A: Geographic Atrophy (GA) Lesion Growth Measured by Fundus Autofluorescence (FAF) From Baseline to Day 505 |
1.95; 1.58 | — |
| PRIMARY Part A: Sensitivity Analysis of the Primary End Point: Mixed Effects Model for Repeated Measurements on GA Lesion Growth Measured by Fundus Autoflourescence |
0.975; 0.913; 0.062; 1.825; 1.710; 0.115 | — |
| PRIMARY Part B: Safety and Tolerability of a Single Intravitreal (IVT) Dose of 10 mg/100 μL of LFG316 in Patients With Advanced AMD). |
27; 11; 1; 0; 99; 51 | — |
| SECONDARY Part A: Change From Baseline in GA Lesions Growth Measured by Fundus Autofluorescence |
0.99; 0.88; 2.78; 2.03 | — |
| SECONDARY Part A: Change in Best Corrected Visual Acuity (BCVA) as Measured by the EDTRS (Early Treatment of Diabetic Retinopathy Study) Scale From Baseline to Days 169, 337 & 505 in Patients Receiving Every 28 Days, Successive IVT Doses of LFG316 Compared to Sham |
43.91; 40.26; 48.38; 42.50; 47.49; 42.97 | — |
| SECONDARY Part A: Summary of Best Corrected Visual Acuity Over Time, Statistical Analysis of Change in Best Corrected Visual Acuity Over Time Parameter: Visual Acuity (EDTRS Letter) BCVA Scale is 0-100, Worst is 0 and Best 100 Eye: FELLOW |
54.66; 55.13; 54.59; 57.33; 52.75; 53.87 | — |
| SECONDARY Part A: Concentrations of Total LFG316 in Blood During the Course of the Study |
0.00; 293; 560; 289; 382; 436 | — |
| SECONDARY Part A: Concentrations of Total C5 in Blood During the Course of the Study |
147000; 142000; 143000; 139000; 149000; 136000 | — |
| SECONDARY Part B: AUC (Area Under the Curve) - Summary Statistics for PK Parameters |
743000; 600000 | — |
| SECONDARY Tmax (hr) |
213 | — |
| SECONDARY Part B: Cmax - Summary Statistic for PK Parameters |
1010 | — |
| SECONDARY Part B: Cmax_D - Summary Statistic for PK Parameters |
101 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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)
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01527500). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.