Wet Macular DegenerationPhase 4MACBETHNCT01896284
Study to Evaluate Efficacy of Aflibercept in Neovascular Age-related Macular Degeneration Patients Non Responders to Anti-Vascular Endothelial Growth Factor
A Phase 4 study testing 0.5mg aflibercept in people with Wet Macular Degeneration, run by Barcelona Macula Foundation at 1 site in Spain.
Trial summary
Patients with neovascular age-related macular degeneration who do not respond to usual treatment with conventional medications may respond to a new drug of the same class which is designed to block a larger fraction of proangiogenic factors. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Wet Macular Degeneration
- What is being tested?
- 0.5mg aflibercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2013to Jun 2015
- 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
- Signed Informed Consent
- Men and women ≥ 50 years of age.
- Any choroidal neovascular membranes (CNVM) lesion (occult, minimally classic or classic) secondary to age-related macular degeneration
- Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity of: 20/32 to 20/320 (letter score of 73 to 25) in the study eye.
- Able to return for ALL clinic visits and complete all study-related procedures.
- Absence of other ocular diseases that could affect visual acuity.
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- Patients without optimal response to ranibizumab or bevacizumab defined as:
- Patient with significant persistent or recurrent fluid (intraretinal or subretinal) on OCT or any leakage on fluorescein angiography despite at least 4 injections within last 6 months, being the last OCT with presence of fluid within the 6 weeks after last treatment with ranibizumab or bevacizumab.
- Patient with significant persistent or recurrent fluid (intraretinal or subretinal) on OCT or any leakage on fluorescein angiography despite three monthly treatment with ranibizumab or bevacizumab.
Who cannot join
- No scar, fibrosis, or atrophy involving the center of the fovea
- No retina pigment epithelium (RPE) rip/tear involving the central fovea
- Participation in another simultaneous interventional clinical trial
- Prior treatment with anti-VEGF or steroids therapy in the study eye within 28 days of baseline
- Prior treatment with photodynamic therapy (PDT)
- Intraocular surgery (including cataract surgery) in the study eye within 2 months preceding Baseline
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- History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study eye
- Active intraocular inflammation in the study eye
- History of cerebral vascular accident, myocardial infarction, transient ischemic attacks within 3 months of study enrollment.
- Unable to undergo fluorescein angiography or fundus photography because of uncontrolled allergies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase IV Study to Evaluate the Efficacy of Aflibercept in Subjects With Neovascular Age-related Macular Degeneration (wAMD), Without Optimal Response to Repeated Monthly Intravitreal Injections of Anti Vascular Endothelial Growth Factor (Anti VEGF-A) Therapy.
Patients with neovascular age-related macular degeneration who do not respond to usual treatment with conventional medications may respond to a new drug of the same class which is designed to block a larger fraction of proangiogenic factors.
- Conditions
- Wet Macular Degeneration
- Being tested
- 0.5mg aflibercept
- Medical subject headings
- Wet Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.5mg afliberceptDrug
Also called EYLEA
0.5mg aflibercept intravitreal injection will be performed every 4 weeks from baseline to week 8 (3 doses) and every 8 weeks until week 32.
| Study group | Role | What they receive |
|---|---|---|
| 0.5mg AFLIBERCEPT injection | Experimental | Patients will receive intravitreal injection of aflibercept 0.5mg at baseline, week 4,8,16,24 and 32. Optionally, if intra or subretinal fluid persists at week 12, patients will receive an additional injection. Receives: Drug: 0.5mg aflibercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with no fluid on Optical Coherence Tomography (OCT) after loading dose of aflibercept
At week 12 an OCT will be performed to evaluate the changes in intra or subretinal fluid and to determine the percentage of patients with no fluid after 3 doses of aflibercept injected on baseline visit, week 4 and week 8.
Measured: Week 12
Secondary outcomes (5)
Changes in best corrected visual acuity (BCVA)after loading dose
Measured: week 12
Changes in OCT central foveal thickness after loading dose
Measured: week 12
Anatomic and Visual Acuity outcomes maintained during (every 8 weeks) treatment.
Measured: week 40
Determine the time to resolution of any intra/sub retinal fluid on OCT
Measured: week 4,8,12,24,32,40
Describe safety of this cohort of patients
Describe the safety of aflibercept in study patients by determining ocular and non ocular adverse events classified according to type, frequency and severity during 40 weeks
Measured: baseline, week 4, 8, 12, 24, 32 and 40
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionNov 2014
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wet Macular DegenerationStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barcelona Macula Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- TFS Trial Form Support, Bayer
- Responsible party
- Sponsor
- Investigators
- Jordi Mones, MD PhD, Principal investigator, Barcelona Macula FoundationCarlos Juan Donate, MD, Principal investigator, Hospital San Carlos, MadridMarta Suárez de Figueroa, MD, Principal investigator, Hosipital Universitario Ramon y CajalJose Luis Olea, MD, Principal investigator, Hospital Son EspasesFrancisco Cabrera, MD, Principal investigator, Hospital Universitario Insular de CanariasLaura Sarasols, MD, Principal investigator, Hospital Universitari General de CatalunyaJavier Araiz, MD, Principal investigator, Instituto Clínico Quirúrgico de Oftalmología de BilbaoJose Maria Ruiz-Moreno, MD, Principal investigator, Hospital Universitario de Albacete
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01896284
- Sponsor's protocol ID
- BMF-AFLI-2013-01
- Other IDs
- 2013-000848-26
- Acronym
- MACBETH
- Status last verified
- Jul 2015
- First submitted
- 8 Jul 2013
- Last updated
- 23 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Study to Evaluate the Efficacy of Aflibercept in Subjects With Neovascular Age-related Macular Degeneration (wAMD), Without Optimal Response to Repeated Monthly Intravitreal Injections of Anti Vascular Endothelial Growth Factor (Anti VEGF-A) Therapy.
- ClinicalTrials.gov ID
- NCT01896284
- Acronym / sponsor ID
- MACBETH / BMF-AFLI-2013-01
- Conditions
- Wet Macular Degeneration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Barcelona Macula FoundationUniversity, hospital or other
- Collaborators
- TFS Trial Form Support, Bayer
- Study start
- Jul 2013 (actual)
- Primary completion
- Nov 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 11 Jul 2013 (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.
Patients with neovascular age-related macular degeneration who do not respond to usual treatment with conventional medications may respond to a new drug of the same class which is designed to block a larger fraction of proangiogenic factors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 0.5mg AFLIBERCEPT injection | Experimental | Drug: 0.5mg afliberceptPatients will receive intravitreal injection of aflibercept 0.5mg at baseline, week 4,8,16,24 and 32. Optionally, if intra or subretinal fluid persists at week 12, patients will receive an additional injection. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Signed Informed Consent
- Men and women ≥ 50 years of age.
- Any choroidal neovascular membranes (CNVM) lesion (occult, minimally classic or classic) secondary to age-related macular degeneration
- Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity of: 20/32 to 20/320 (letter score of 73 to 25) in the study eye.
- Able to return for ALL clinic visits and complete all study-related procedures.
Key exclusion criteria (10 listed)
- No scar, fibrosis, or atrophy involving the center of the fovea
- No retina pigment epithelium (RPE) rip/tear involving the central fovea
- Participation in another simultaneous interventional clinical trial
- Prior treatment with anti-VEGF or steroids therapy in the study eye within 28 days of baseline
- Prior treatment with photodynamic therapy (PDT)
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 |
|---|---|---|
| 0.5mg afliberceptAlso: EYLEA0.5mg aflibercept intravitreal injection will be performed every 4 weeks from baseline to week 8 (3 doses) and every 8 weeks until week 32. | Drug | 0.5mg AFLIBERCEPT injection |
Primary outcome
Percentage of patients with no fluid on Optical Coherence Tomography (OCT) after loading dose of aflibercept
Time frame: Week 12
At week 12 an OCT will be performed to evaluate the changes in intra or subretinal fluid and to determine the percentage of patients with no fluid after 3 doses of aflibercept injected on baseline visit, week 4 and week 8.
5 secondary outcomes
Changes in best corrected visual acuity (BCVA)after loading dose
Time frame: week 12
Changes in OCT central foveal thickness after loading dose
Time frame: week 12
Anatomic and Visual Acuity outcomes maintained during (every 8 weeks) treatment.
Time frame: week 40
Determine the time to resolution of any intra/sub retinal fluid on OCT
Time frame: week 4,8,12,24,32,40
Describe safety of this cohort of patients
Time frame: baseline, week 4, 8, 12, 24, 32 and 40
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 23 Nov 2018.
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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.
Jordi Mones, MD PhD principal investigator
Barcelona Macula Foundation
Carlos Juan Donate, MD principal investigator
Hospital San Carlos, Madrid
Marta Suárez de Figueroa, MD principal investigator
Hosipital Universitario Ramon y Cajal
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 0.5mg aflibercept in people with Wet Macular Degeneration, run by Barcelona Macula Foundation at 1 site in Spain.
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 9 inclusion and 10 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 23 Nov 2018. 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 Spain. 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?
Percentage of patients with no fluid on Optical Coherence Tomography (OCT) after loading dose of aflibercept (time frame: Week 12). 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 23 Nov 2018.