Intravitreal LFG316 in Patients With Age-related Macular Degeneration (AMD)

Novartis

Status and phase: Completed; Phase 2

Conditions: Geographic Atrophy; Age-related Macular Degeneration

Treatments: Drug: LFG316; Drug: LFG316 Lower dose; Drug: Sham

Study type: Interventional

Funder types: Industry

Identifiers

NCT01527500

CLFG316A2203

Details and patient eligibility

About

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.

Enrollment: 158 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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158 participants in 3 patient groups

LFG316 higher dose

Experimental group

Description:

LFG316 10 mg/100 μL

Treatment:

Drug: LFG316

Sham

Sham Comparator group

Description:

Sham injection

Treatment:

Drug: Sham

LFG316 lower dose

Experimental group

Description:

LFG316 5 mg/ 50 μL

Treatment:

Drug: LFG316 Lower dose