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

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.

Study Overview

• Status: Completed
• Conditions: Neovascular Age Related Macular Degeneration
• Intervention / Treatment: Drug: Lucentis every 4 weeks; Drug: Lucentis every 12 weeks; Drug: Lucentis (Treat and extend)

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • 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
      • Retinal Consultants of Arizona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Central foveal thickness	Central foveal thickness as determined by Spectral Domain-Ocular Coherence Tomography (SD-OCT).	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of office visits needed	Number of office visits completed for patients on Arm C (treat-and-extend arm), compared to those on Arms A and B	12 months
Number of required injections	Number of Lucentis® injections administered to patients in Arm C, compared to those on Arms A and B	12 months

Collaborators and Investigators

• Sponsor: Retinal Consultants of Arizona
• Collaborators: Genentech, Inc.
• Investigators: Principal Investigator: Pravin U Dugel, MD, Retinal Consultants of Arizona

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: May 20, 2013
• First Submitted That Met QC Criteria: May 24, 2013
• First Posted (Estimate): May 27, 2013

Study Record Updates

• Last Update Posted (Actual): October 4, 2017
• Last Update Submitted That Met QC Criteria: October 2, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: AMD; Wet AMD; Choroidal neovascularization; Neovascular membrane
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Wet Macular Degeneration; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Ranibizumab
• Other Study ID Numbers: ML28727