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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

158 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-25

Study Completion Date

2015-06-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety and Efficacy of Intravitreal LFG316 in Wet Age Related Macular Degeneration (AMD)

NCT01535950

Neovascular Age-elated Macular Degeneration (Wet AMD) Exudative Macular Degeneration

COMPLETED PHASE2

Intravitreal LFG316 in Patients With Advanced Age-related Macular Degeneration

NCT01255462

COMPLETED PHASE1

Safety and Tolerability of Intravenous LFG316 in Wet Age-related Macular Degeneration (AMD).

NCT01624636

Neovascular Age-related Macular Degeneration

TERMINATED PHASE2

A Study to Learn How Avacincaptad Pegol (Izervay™) is Used in Clinical Practice in People Who Have Geographic Atrophy

NCT06779773

Geographic Atrophy Macular Degeneration

RECRUITING

A Study of NGM621 in Participants With Geographic Atrophy

NCT04465955

Geographic Atrophy

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Geographic Atrophy Age-related Macular Degeneration

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

LFG316 higher dose

LFG316 10 mg/100 μL

Group Type EXPERIMENTAL

LFG316

Intervention Type DRUG

LFG316 5 mg/50 μL solution for IVT injection,

Sham

Sham injection

Group Type SHAM_COMPARATOR

Sham

Intervention Type DRUG

Sham injection (akin to intravitreal injection but without intravitreal needle; no investigational drug given)

LFG316 lower dose

LFG316 5 mg/ 50 μL

Group Type EXPERIMENTAL

LFG316 Lower dose

Intervention Type DRUG

LFG316 5 mg/50 μL solution for IVT Injection

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

LFG316

LFG316 5 mg/50 μL solution for IVT injection,

Intervention Type DRUG

Sham

Sham injection (akin to intravitreal injection but without intravitreal needle; no investigational drug given)

Intervention Type DRUG

LFG316 Lower dose

LFG316 5 mg/50 μL solution for IVT Injection

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No