LUCAS (Lucentis Compared to Avastin Study)

NCT01127360 | Completed Phase 4 DMC

• 1 other identifier: 1008
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Anti-VEGF; Ranibizumab; Bevacizumab; exudative; macular degeneration

Outcome Measures

Primary Outcomes (1)

• Mean change in VA at 1 and 2 years as measured with the ETDRS chart

  Mean change in VA at 1 and 2 years as measured with the ETDRS chart (with a non-inferiority limit of 5 letters)

  After 1 and 2 years

Secondary Outcomes (5)

• Number of treatments.

  After 1 and 2 years

• Proportion of patients losing fewer than 15 letters on ETDRS chart

  After 1 and 2 years

• Macular morphology as measured by FA and OCT after 2 years.

  After 2 years

• Adverse events

  2 years

• Number of non-responders.

  After 2 years

Study Arms (2)

Bevacizumab

EXPERIMENTAL

Bevacizumab 1,25 mg, intravitreal injections every 4th to 12th week

Drug: Bevacizumab; Drug: Ranibizumab

Ranibizumab

ACTIVE COMPARATOR

Ranibizumab 0,5 mg, intravitreal injection, every 4th to 12th week

Drug: Bevacizumab; Drug: Ranibizumab

Interventions

Bevacizumab DRUG

Intravitreal injections

Also known as: Avastin

Bevacizumab; Ranibizumab

Ranibizumab DRUG

Intravitreal injections

Also known as: Lucentis

Bevacizumab; Ranibizumab

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women.
• Age ≥50 years.
• Wet AMD in the study eye, defined as:
• Not previously treated active choroidal neovascular membrane (CNV), including retinal angiomatous proliferation (RAP), with edema involving the fovea as demonstrated with optical coherence tomography (OCT) and fluorescein angiography (FA). FA shall not be older than 7 days at randomization.
• Best corrected visual acuity (BCVA) in the study eye 20/25 - 20/320.
• Only one eye of each study patient may be recruited into the study. If the non-study eye is being treated with intravitreal anti-VEGF therapy, or develops wet AMD, then the same drug being used in the study eye shall be used in the non-study eye. Treatment must be given double-blind in the non-study eye as well.

You may not qualify if:

• Previous treatment of CNV in the study eye.
• Participation in another AMD study, or use of other investigational medicines.
• Anti-VEGF treatment in the non-study eye during the last 4 weeks.
• Earlier or current treatment with systemic anti-VEGF drug.
• Subretinal hemorrhage and/or fibrosis that involves ≥50 percent of the CNV lesion in the study eye.
• CNV of other pathogenesis, such as pathologic myopia (defined as having a spherical equivalent of \>8 diopters myopia) or Presumed Ocular Histoplasmosis Syndrome (POHS).
• Presence of retinal diseases other than AMD (diabetic retinopathy, macular hole, etc) that lead to loss of visual acuity in the study eye.
• Cataract that will presumably require operation within 2 years or other intraocular surgery or laser treatment during the last 3 months.
• Impaired visualization of the retina (by vitreous hemorrhage, corneal dystrophy, etc.) that may hamper adequate diagnosis.
• Intraocular pressure ≥25 mm Hg, measured before mydriasis, or uncontrolled glaucoma as evaluated by the examining ophthalmologist.
• Active uveitis in the study eye or intraocular inflammation after use of Lucentis or Avastin in the non-study eye.
• Infection in one or both eyes.
• Premenopausal women who do not use appropriate birth control, or who are nursing.
• Patients who for mental or physical reasons are unable to comply with the study's procedures,
• Serious disease where there is a probability of death within the duration of the study.

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Department of Ophthalmology, Oslo University Hospital

Oslo, 0407, Norway

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

Bevacizumab; Ranibizumab

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Andreas Moan

  Director of Research at Oslo University Hospital

  STUDY DIRECTOR

• Ragnheidur Bragadottir, MD. PhD.

  Department of Ophthtalmology, Oslo University Hospital

  STUDY CHAIR

• Karina Berg, MD.

  Department of Ophthalmology, Oslo University Hospital

  PRINCIPAL INVESTIGATOR

• Terje Pedersen, Professor

  Department of Preventative Medicine, Oslo University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2010
• First Posted: May 20, 2010
• Study Start: March 1, 2009
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: January 16, 2015

Record last verified: 2015-01

Locations

NO (1)