Neovascular Age Related Macular DegenerationPhase 4LibertyNCT01863199
Impact of Home Monitoring to Decrease the Treatment Burden for Neovascular Age-related Macular Degeneration (AMD)
A Phase 4 study testing Lucentis (Treat and extend), Lucentis every 4 weeks and Lucentis every 12 weeks in people with Neovascular Age Related Macular Degeneration, run by Retinal Consultants of Arizona at 4 sites in United States.
Trial summary
A study to use in home technology to reduce the burden of in office visits and injections. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Neovascular Age Related Macular Degeneration
- What is being tested?
- Lucentis (Treat and extend), Lucentis every 4 weeks and Lucentis every 12 weeks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 4 sitesUnited States
- Study dates
- May 2013to Dec 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
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
- Age > 50 years
- Choroidal neovascular membrane (CNV) secondary to AMD, as confirmed by the patient's medical history and a documented diagnosis of CNV
- The study eye must have received at least 3 anti-Vascular endothelial growth factor (VEGF) treatments prior to the screening visit, with at least 2 anti-VEGF treatments over the preceding 3 months.
- Best-corrected visual acuity (BCVA) of 20/32 to 20/200 Snellen equivalent in the study eye
- Noted presence of intra- or sub-retinal fluid on OCT in the study eye
- Adequate pupillary dilation to permit thorough ocular examination and testing in both eyes
- Proficiency in using the DigiSight SightBook™ mobile vision assessment tool on study-supplied Apple iPad or iPod device
Who cannot join
- CNV in the study eye due to any reason other than AMD
- Active uncontrolled glaucoma
- Had any intraocular surgeries in the study eye within 3 months of enrollment or are known or likely candidates for intraocular surgery (including cataract surgery) in the study eye within 1 year of enrollment
- Acute or chronic ocular or periocular infection in the study eye, uveitis or ocular inflammation in the study eye
- Received Photo Dynamic Therapy (PDT) in the study eye within 60 days, or laser photocoagulation within 14 days prior to screening
- Currently using any periocular or intravitreal steroids within 3 months prior to screening (study eye)
Show all 12Show fewer
- Unstable or severe cardiovascular disease, e.g., congestive heart failure (New York Heart Association Functional class III/IV), myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina, or critical limb ischemia
- Poorly controlled diabetes
- Cerebrovascular disease within 12 months prior to Screening
- Dementia or neurodegenerative disease (e.g., Alzheimer's disease, Parkinson's disease)
- Received any investigational product within 30 days prior to Screening
- Inability to properly use the SightBook™ app
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Retinal Consultants of Arizona
Gilbert, Arizona, 85296
Retinal Consultants of Arizona
Mesa, Arizona, 85210
Retinal Consultants of Arizona
Peoria, Arizona, 85381
Retinal Consultants of Arizona
Phoenix, Arizona, 85014
About this study
Official title: A Clinical Trial to Assess the Impact of Home Monitoring to Decrease the Treatment Burden for Neovascular Macular Degeneration (the LIBERTY Study).
A study to use in home technology to reduce the burden of in office visits and injections.
Read the detailed description
Without frequent measurement of vision to monitor disease progression some people may be under-treated, while others over-treated. Under-treatment can lead to severe and irreversible disease progression and associated loss of vision. Over-treatment is expensive, uncomfortable and potentially increases the risk of complications. A self-monitoring device such as DigiSight can help subjects keep close control of their treatment, but alleviate the burden of in office monitoring visits. A decreased number of office visits in combination with the home self-monitoring may provide an effective alternative dosing regimen, allowing the physician and subject to closely track the disease progression and treatment effect without the demands of monthly or frequent visits to the office.
- Being tested
- Lucentis (Treat and extend), Lucentis every 4 weeks, Lucentis every 12 weeks
- Keywords
- Wet AMD, AMD, Choroidal neovascularization, Neovascular membrane
- Medical subject headings
- Choroidal Neovascularization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lucentis (Treat and extend)Drug
Lucentis 0.5mg will be administered on an as needed basis after a loading dose using a treatment extending protocol and home monitoring.
Lucentis every 4 weeksDrug
Lucentis 0.5mg administered intravitreally every four weeks for 12 months
Lucentis every 12 weeksDrug
Lucentis 0.5mg administered intravitreally every twelve weeks for 12 months
| Study group | Role | What they receive |
|---|---|---|
| Lucentis every 4 weeks | Active comparator | Lucentis 0.5mg administered intravitreally every four weeks for 12 months Receives: Drug: Lucentis every 4 weeks |
| Lucentis every 12 weeks | Active comparator | Lucentis 0.5mg administered intravitreally every 12 weeks Receives: Drug: Lucentis every 12 weeks |
| Treat and extend | Experimental | Lucentis 0.5mg will be administered on an as needed basis after a loading dose using a treatment extending protocol and home monitoring. Receives: Drug: Lucentis (Treat and extend) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best corrected visual acuity
Best corrected visual acuity (BCVA), as assessed by the number of letters read correctly on the Early Treatment Diabetic Retinoptahy Study (ETDRS) eye chart at a starting test distance of 4 meters, at Months 3, 6, 9 and 12
Measured: 12 months
Secondary outcomes (1)
Central foveal thickness
Central foveal thickness as determined by Spectral Domain-Ocular Coherence Tomography (SD-OCT).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2013 (estimated)
- Study startMay 2013
- Primary completionNov 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neovascular Age Related 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Retinal Consultants of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Pravin U Dugel, MD, Principal investigator, Retinal Consultants of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01863199
- Sponsor's protocol ID
- ML28727
- Acronym
- Liberty
- Status last verified
- Oct 2017
- First submitted
- 20 May 2013
- Last updated
- 4 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Assess the Impact of Home Monitoring to Decrease the Treatment Burden for Neovascular Macular Degeneration (the LIBERTY Study).
- ClinicalTrials.gov ID
- NCT01863199
- Acronym / sponsor ID
- Liberty / ML28727
- Keywords
- Wet AMD, AMD, Choroidal neovascularization, Neovascular membrane
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Retinal Consultants of ArizonaUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- May 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 27 May 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.
A study to use in home technology to reduce the burden of in office visits and injections.
Detailed description
Without frequent measurement of vision to monitor disease progression some people may be under-treated, while others over-treated. Under-treatment can lead to severe and irreversible disease progression and associated loss of vision. Over-treatment is expensive, uncomfortable and potentially increases the risk of complications. A self-monitoring device such as DigiSight can help subjects keep close control of their treatment, but alleviate the burden of in office monitoring visits. A decreased number of office visits in combination with the home self-monitoring may provide an effective alternative dosing regimen, allowing the physician and subject to closely track the disease progression and treatment effect without the demands of monthly or frequent visits to the office.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lucentis every 4 weeks | Active comparator | Drug: Lucentis every 4 weeksLucentis 0.5mg administered intravitreally every four weeks for 12 months |
| Lucentis every 12 weeks | Active comparator | Drug: Lucentis every 12 weeksLucentis 0.5mg administered intravitreally every 12 weeks |
| Treat and extend | Experimental | Drug: Lucentis (Treat and extend)Lucentis 0.5mg will be administered on an as needed basis after a loading dose using a treatment extending protocol and home monitoring. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
- Age > 50 years
- Choroidal neovascular membrane (CNV) secondary to AMD, as confirmed by the patient's medical history and a documented diagnosis of CNV
- The study eye must have received at least 3 anti-Vascular endothelial growth factor (VEGF) treatments prior to the screening visit, with at least 2 anti-VEGF treatments over the preceding 3 months.
- Best-corrected visual acuity (BCVA) of 20/32 to 20/200 Snellen equivalent in the study eye
Key exclusion criteria (12 listed)
- CNV in the study eye due to any reason other than AMD
- Active uncontrolled glaucoma
- Had any intraocular surgeries in the study eye within 3 months of enrollment or are known or likely candidates for intraocular surgery (including cataract surgery) in the study eye within 1 year of enrollment
- Acute or chronic ocular or periocular infection in the study eye, uveitis or ocular inflammation in the study eye
- Received Photo Dynamic Therapy (PDT) in the study eye within 60 days, or laser photocoagulation within 14 days prior to screening
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 |
|---|---|---|
| Lucentis (Treat and extend)Lucentis 0.5mg will be administered on an as needed basis after a loading dose using a treatment extending protocol and home monitoring. | Drug | Treat and extend |
| Lucentis every 4 weeksLucentis 0.5mg administered intravitreally every four weeks for 12 months | Drug | Lucentis every 4 weeks |
| Lucentis every 12 weeksLucentis 0.5mg administered intravitreally every twelve weeks for 12 months | Drug | Lucentis every 12 weeks |
Primary outcome
Best corrected visual acuity
Time frame: 12 months
Best corrected visual acuity (BCVA), as assessed by the number of letters read correctly on the Early Treatment Diabetic Retinoptahy Study (ETDRS) eye chart at a starting test distance of 4 meters, at Months 3, 6, 9 and 12
1 secondary outcome
Central foveal thickness
Time frame: 12 months
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 4 Oct 2017.
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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.
Pravin U Dugel, MD principal investigator
Retinal Consultants of Arizona
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lucentis (Treat and extend), Lucentis every 4 weeks and Lucentis every 12 weeks in people with Neovascular Age Related Macular Degeneration, run by Retinal Consultants of Arizona at 4 sites in United States.
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 8 inclusion and 12 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 4 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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?
Best corrected visual acuity (time frame: 12 months). 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 4 Oct 2017.