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Impact of Home Monitoring to Decrease the Treatment Burden for Neovascular Age-related Macular Degeneration (AMD) (Liberty)

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ClinicalTrials.gov Identifier: NCT01863199
Recruitment Status : Completed
First Posted : May 27, 2013
Last Update Posted : October 4, 2017
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Retinal Consultants of Arizona

Brief Summary:
A study to use in home technology to reduce the burden of in office visits and injections.

Condition or disease Intervention/treatment Phase
Neovascular Age Related Macular Degeneration Drug: Lucentis (Treat and extend) Drug: Lucentis every 4 weeks Drug: Lucentis every 12 weeks Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Trial to Assess the Impact of Home Monitoring to Decrease the Treatment Burden for Neovascular Macular Degeneration (the LIBERTY Study).
Study Start Date : May 2013
Actual Primary Completion Date : November 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab

Arm Intervention/treatment
Active Comparator: Lucentis every 4 weeks
Lucentis 0.5mg administered intravitreally every four weeks for 12 months
Drug: Lucentis every 4 weeks
Lucentis 0.5mg administered intravitreally every four weeks for 12 months

Active Comparator: Lucentis every 12 weeks
Lucentis 0.5mg administered intravitreally every 12 weeks
Drug: Lucentis every 12 weeks
Lucentis 0.5mg administered intravitreally every twelve weeks for 12 months

Experimental: 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: 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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Central foveal thickness [ Time Frame: 12 months ]
    Central foveal thickness as determined by Spectral Domain-Ocular Coherence Tomography (SD-OCT).


Other Outcome Measures:
  1. Number of office visits needed [ Time Frame: 12 months ]
    Number of office visits completed for patients on Arm C (treat-and-extend arm), compared to those on Arms A and B

  2. Number of required injections [ Time Frame: 12 months ]
    Number of Lucentis® injections administered to patients in Arm C, compared to those on Arms A and B



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01863199


Locations
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United States, Arizona
Retinal Consultants of Arizona
Gilbert, Arizona, United States, 85296
Retinal Consultants of Arizona
Mesa, Arizona, United States, 85210
Retinal Consultants of Arizona
Peoria, Arizona, United States, 85381
Retinal Consultants of Arizona
Phoenix, Arizona, United States, 85014
Sponsors and Collaborators
Retinal Consultants of Arizona
Genentech, Inc.
Investigators
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Principal Investigator: Pravin U Dugel, MD Retinal Consultants of Arizona

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Responsible Party: Retinal Consultants of Arizona
ClinicalTrials.gov Identifier: NCT01863199     History of Changes
Other Study ID Numbers: ML28727
First Posted: May 27, 2013    Key Record Dates
Last Update Posted: October 4, 2017
Last Verified: October 2017

Keywords provided by Retinal Consultants of Arizona:
Wet AMD
AMD
Choroidal neovascularization
Neovascular membrane

Additional relevant MeSH terms:
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Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Ranibizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents