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LUCAS (Lucentis Compared to Avastin Study)

NCT01127360 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 420

Last updated 2015-01-16

No results posted yet for this study

Summary

Age-related macular degeneration (AMD) is the most common cause of blindness in individuals over 50 years of age. Bevacizumab and ranibizumab are two agents developed by the American pharmaceutical corporation Genentech, both of which inhibit blood vessel growth factors. These drugs, when injected intraocularly, reduce the pathological growth of blood vessels in the macular area of the eye. Bevacizumab (Avastin) is an antibody developed for intravenous treatment of metastasized colon cancer. Ranibizumab (Lucentis) is an antibody fragment developed from a similar antibody. It was introduced 2006 as an effective treatment for wet AMD. Treatment costs are, however, up to 50 times higher compared to use of bevacizumab. Avastin has shown similar effects to ranibizumab, and has been used off-label in many countries, both before and after Lucentis received approval. There is thus a recognized need for large randomized studies to garner proper scientific proof of Avastin's effectiveness regarding exudative AMD.

LUCAS is a randomized multicenter study, performed in Norway, comparing ranibizumab and bevacizumab use for AMD. The goal of the study was to demonstrate if the two agents were equivalent regarding both efficacy and safety. A total of 441 patients with objective evidence of wet AMD were randomized to a double-blind treatment with ranibizumab or bevacizumab over the course of 2 years. The treatment interval was determined by a "Treat and Extend" protocol.

Conditions

  • Exudative Age-related Macular Degeneration

Interventions

DRUG

Bevacizumab

Intravitreal injections

DRUG

Ranibizumab

Intravitreal injections

Sponsors & Collaborators

  • Oslo University Hospital

    lead OTHER

Principal Investigators

  • Andreas Moan · Director of Research at Oslo University Hospital

  • Ragnheidur Bragadottir, MD. PhD. · Department of Ophthtalmology, Oslo University Hospital

  • Karina Berg, MD. · Department of Ophthalmology, Oslo University Hospital

  • Terje Pedersen, Professor · Department of Preventative Medicine, Oslo University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2014-08-31
Completion
2014-08-31

Countries

  • Norway

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01127360 on ClinicalTrials.gov