Efficacy of Ranibizumab Prn Treatment Compared to Aflibercept Bimonthly Intravitreal Injections on Retinal Thickness Stability in Patients With Wet AMD (SALT)

Novartis

Status and phase

Completed

Phase 4

Conditions

Neovascular Age-related Macular Degeneration

Treatments

Drug: Aflibercept

Drug: Ranibizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT01958918

CRFB002ADE23

Details and patient eligibility

About

The purpose of this study was to compare the efficacy of 0.5 mg ranibizumab versus 2 mg aflibercept bimonthly intravitreal injections on retinal thickness stability.

Full description

Patients attended 14 scheduled study visits during 12 months.

Enrollment

712 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

Visual impairment predominantly due to neovascular AMD Active
Newly diagnosed, untreated, angiographically documented choroidal neovascularization (CNV) lesion

Key Exclusion Criteria:

Stroke or myocardial infarction less than 3 Months prior to study entry
Active injection or inflammation of either eye at the time of study entry
Any type of systemic disease (or received treatment for it), including any medical condition (controlled or uncontrolled) that were to be expected to progress, recur, or change to an extent which could bias the assessment of the clinical status of the patient to a significant degree or put the patient at special risk