Exudative Age-related Macular DegenerationPhase 4LUCASNCT01127360
LUCAS (Lucentis Compared to Avastin Study)
A Phase 4 study testing Bevacizumab and Ranibizumab in people with Exudative Age-related Macular Degeneration, run by Oslo University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Exudative Age-related Macular Degeneration
- What is being tested?
- Bevacizumab and Ranibizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2009to Aug 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: LUCAS. A Randomized, Prospective, Multicenter Study Comparing the Effect of Intravitreal Injection of Bevacizumab to Ranibizumab When Given to Patients With Neovascular Age-related Macular Degeneration
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.
Read the detailed description
LUCAS (LUcentis Compared to Avastin Study) A randomized, double-blind, prospective multicenter study comparing the effect of intravitreal injection of bevacizumab (Avastin) to ranibizumab (Lucentis) when given to patients with exudative (wet) age-related macular degeneration in Norway.
Version: 4, Protocol: 166-09, EudraCT: 2008-004225-41
Purpose:
LUCAS is a prospective, randomized, multicenter study comparing the effects of intravitreal injection of bevacizumab (Avastin) with ranibizumab (Lucentis) when given to patients with exudative (wet) AMD in Norway.
The study will include 420 patients to be recruited starting March 2009. The study will continue for 2 years after completed enrollment.
Design:
LUCAS is a multicenter, randomized, double-blind study, with 1:1 parallel groups treated with either bevacizumab (Avastin) 0.05 ml (25 mg/ml) or ranibizumab (Lucentis) 0,05 ml (10 mg/ml). The drug is injected intravitreally according to an "inject and extend" principle (5).
Randomization will be stratified by center and performed with minimization according to prognostic factors.
Treatment Regimen:
Bevacizumab (Avastin) will be given as an intravitreal injection of 0.05ml (25 mg/ml) from a vial containing 4 ml.
Ranibizumab (Lucentis) will be given as an intravitreal injection of 0.05 ml (10 mg/ml) from a vial containing 0.23 ml.
Follow-up and treatment will follow a principle called "inject and extend." This connotes the following: initial follow-up and injection with a 4 week intervals until the macula is dry. When dry, then follow-up and injection will be increased 2 weeks at a time. If the patient has a recurrence of wet AMD, then the interval is reduced by 2 weeks at a time until the macula is once again dry. The shortest interval is 4 weeks. When once again extending, the treatment interval shall not be as long as the interval of the original recurrence, as this could confer risk for new activity. Therefore further follow-up and injection occurs at the "ideal" interval which is hereby defined as being 2 weeks less than that of the original recurrence. With this method, the patient receives an injection at each follow-up, presuming that no complications occur. The maximum interval is limited to 12 weeks. Treatment will continue for 2 years. After the study is completed, then the patient is to be offered continued treatment, in accordance with the ophthalmology department's routines, If there is no response to treatment after 3 injections with a 4 week interval, then the patient shall be removed from the study and be offered alternative treatment, such as combination treatment with photodynamic therapy (PDT).
- Being tested
- Bevacizumab, Ranibizumab
- Keywords
- Anti-VEGF, Ranibizumab, Bevacizumab, exudative, macular degeneration
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Also called Avastin
Intravitreal injections
RanibizumabDrug
Also called Lucentis
Intravitreal injections
| Study group | Role | What they receive |
|---|---|---|
| Bevacizumab | Experimental | Bevacizumab 1,25 mg, intravitreal injections every 4th to 12th week Receives: Drug: Bevacizumab; Drug: Ranibizumab |
| Ranibizumab | Active comparator | Ranibizumab 0,5 mg, intravitreal injection, every 4th to 12th week Receives: Drug: Bevacizumab; Drug: Ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: After 1 and 2 years
Secondary outcomes (5)
Number of treatments.
Number of treatments.
Measured: After 1 and 2 years
Proportion of patients losing fewer than 15 letters on ETDRS chart
Proportion of patients losing fewer than 15 letters on ETDRS chart
Measured: After 1 and 2 years
Macular morphology as measured by FA and OCT after 2 years.
Macular morphology as measured by FA and OCT after 2 years.
Measured: After 2 years
Adverse events
Frequency of ophthalmological and other health related adverse events during the 2 year study.
Measured: 2 years
Number of non-responders.
Number of non-responders.
Measured: After 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2010 (estimated)
- Study startMar 2009
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exudative Age-related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andreas Moan, Study director, Director of Research at Oslo University HospitalRagnheidur Bragadottir, MD. PhD., Study chair, Department of Ophthtalmology, Oslo University HospitalKarina Berg, MD., Principal investigator, Department of Ophthalmology, Oslo University HospitalTerje Pedersen, Professor, Study chair, Department of Preventative Medicine, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01127360
- Sponsor's protocol ID
- 1008
- Acronym
- LUCAS
- Status last verified
- Jan 2015
- First submitted
- 19 May 2010
- Last updated
- 16 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LUCAS. A Randomized, Prospective, Multicenter Study Comparing the Effect of Intravitreal Injection of Bevacizumab to Ranibizumab When Given to Patients With Neovascular Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT01127360
- Acronym / sponsor ID
- LUCAS / 1008
- Keywords
- Anti-VEGF, Ranibizumab, Bevacizumab, exudative, macular degeneration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 20 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
LUCAS (LUcentis Compared to Avastin Study) A randomized, double-blind, prospective multicenter study comparing the effect of intravitreal injection of bevacizumab (Avastin) to ranibizumab (Lucentis) when given to patients with exudative (wet) age-related macular degeneration in Norway.
Version: 4, Protocol: 166-09, EudraCT: 2008-004225-41
Purpose:
LUCAS is a prospective, randomized, multicenter study comparing the effects of intravitreal injection of bevacizumab (Avastin) with ranibizumab (Lucentis) when given to patients with exudative (wet) AMD in Norway.
The study will include 420 patients to be recruited starting March 2009. The study will continue for 2 years after completed enrollment.
Design:
LUCAS is a multicenter, randomized, double-blind study, with 1:1 parallel groups treated with either bevacizumab (Avastin) 0.05 ml (25 mg/ml) or ranibizumab (Lucentis) 0,05 ml (10 mg/ml). The drug is injected intravitreally according to an "inject and extend" principle (5).
Randomization will be stratified by center and performed with minimization according to prognostic factors.
Treatment Regimen:
Bevacizumab (Avastin) will be given as an intravitreal injection of 0.05ml (25 mg/ml) from a vial containing 4 ml.
Ranibizumab (Lucentis) will be given as an intravitreal injection of 0.05 ml (10 mg/ml) from a vial containing 0.23 ml.
Follow-up and treatment will follow a principle called "inject and extend." This connotes the following: initial follow-up and injection with a 4 week intervals until the macula is dry. When dry, then follow-up and injection will be increased 2 weeks at a time. If the patient has a recurrence of wet AMD, then the interval is reduced by 2 weeks at a time until the macula is once again dry. The shortest interval is 4 weeks. When once again extending, the treatment interval shall not be as long as the interval of the original recurrence, as this could confer risk for new activity. Therefore further follow-up and injection occurs at the "ideal" interval which is hereby defined as being 2 weeks less than that of the original recurrence. With this method, the patient receives an injection at each follow-up, presuming that no complications occur. The maximum interval is limited to 12 weeks. Treatment will continue for 2 years. After the study is completed, then the patient is to be offered continued treatment, in accordance with the ophthalmology department's routines, If there is no response to treatment after 3 injections with a 4 week interval, then the patient shall be removed from the study and be offered alternative treatment, such as combination treatment with photodynamic therapy (PDT).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bevacizumab | Experimental | Drug: Bevacizumab, Drug: RanibizumabBevacizumab 1,25 mg, intravitreal injections every 4th to 12th week |
| Ranibizumab | Active comparator | Drug: Bevacizumab, Drug: RanibizumabRanibizumab 0,5 mg, intravitreal injection, every 4th to 12th week |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BevacizumabAlso: AvastinIntravitreal injections | Drug | Bevacizumab, Ranibizumab |
| RanibizumabAlso: LucentisIntravitreal injections | Drug | Bevacizumab, Ranibizumab |
Primary outcome
Mean change in VA at 1 and 2 years as measured with the ETDRS chart
Time frame: After 1 and 2 years
Mean change in VA at 1 and 2 years as measured with the ETDRS chart (with a non-inferiority limit of 5 letters)
5 secondary outcomes
Number of treatments.
Time frame: After 1 and 2 years
Proportion of patients losing fewer than 15 letters on ETDRS chart
Time frame: After 1 and 2 years
Macular morphology as measured by FA and OCT after 2 years.
Time frame: After 2 years
Adverse events
Time frame: 2 years
Number of non-responders.
Time frame: After 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Moan study director
Director of Research at Oslo University Hospital
Ragnheidur Bragadottir, MD. PhD. study chair
Department of Ophthtalmology, Oslo University Hospital
Karina Berg, MD. principal investigator
Department of Ophthalmology, Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bevacizumab and Ranibizumab in people with Exudative Age-related Macular Degeneration, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in VA at 1 and 2 years as measured with the ETDRS chart (time frame: After 1 and 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2015.