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

Primary Purpose

Neovascular Age Related Macular Degeneration

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Lucentis (Treat and extend)
Lucentis every 4 weeks
Lucentis every 12 weeks
Sponsored by
Retinal Consultants of Arizona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neovascular Age Related Macular Degeneration focused on measuring Wet AMD, AMD, Choroidal neovascularization, Neovascular membrane

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Retinal Consultants of Arizona
  • Retinal Consultants of Arizona
  • Retinal Consultants of Arizona
  • Retinal Consultants of Arizona

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Experimental

Arm Label

Lucentis every 4 weeks

Lucentis every 12 weeks

Treat and extend

Arm Description

Lucentis 0.5mg administered intravitreally every four weeks for 12 months

Lucentis 0.5mg administered intravitreally every 12 weeks

Lucentis 0.5mg will be administered on an as needed basis after a loading dose using a treatment extending protocol and home monitoring.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Central foveal thickness
Central foveal thickness as determined by Spectral Domain-Ocular Coherence Tomography (SD-OCT).

Full Information

First Posted
May 20, 2013
Last Updated
October 2, 2017
Sponsor
Retinal Consultants of Arizona
Collaborators
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01863199
Brief Title
Impact of Home Monitoring to Decrease the Treatment Burden for Neovascular Age-related Macular Degeneration (AMD)
Acronym
Liberty
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 Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Retinal Consultants of Arizona
Collaborators
Genentech, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neovascular Age Related Macular Degeneration
Keywords
Wet AMD, AMD, Choroidal neovascularization, Neovascular membrane

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lucentis every 4 weeks
Arm Type
Active Comparator
Arm Description
Lucentis 0.5mg administered intravitreally every four weeks for 12 months
Arm Title
Lucentis every 12 weeks
Arm Type
Active Comparator
Arm Description
Lucentis 0.5mg administered intravitreally every 12 weeks
Arm Title
Treat and extend
Arm Type
Experimental
Arm Description
Lucentis 0.5mg will be administered on an as needed basis after a loading dose using a treatment extending protocol and home monitoring.
Intervention Type
Drug
Intervention Name(s)
Lucentis (Treat and extend)
Intervention Description
Lucentis 0.5mg will be administered on an as needed basis after a loading dose using a treatment extending protocol and home monitoring.
Intervention Type
Drug
Intervention Name(s)
Lucentis every 4 weeks
Intervention Description
Lucentis 0.5mg administered intravitreally every four weeks for 12 months
Intervention Type
Drug
Intervention Name(s)
Lucentis every 12 weeks
Intervention Description
Lucentis 0.5mg administered intravitreally every twelve weeks for 12 months
Primary Outcome Measure Information:
Title
Best corrected visual acuity
Description
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
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Central foveal thickness
Description
Central foveal thickness as determined by Spectral Domain-Ocular Coherence Tomography (SD-OCT).
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Number of office visits needed
Description
Number of office visits completed for patients on Arm C (treat-and-extend arm), compared to those on Arms A and B
Time Frame
12 months
Title
Number of required injections
Description
Number of Lucentis® injections administered to patients in Arm C, compared to those on Arms A and B
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pravin U Dugel, MD
Organizational Affiliation
Retinal Consultants of Arizona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Retinal Consultants of Arizona
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85296
Country
United States
Facility Name
Retinal Consultants of Arizona
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85210
Country
United States
Facility Name
Retinal Consultants of Arizona
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
Retinal Consultants of Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85014
Country
United States

12. IPD Sharing Statement

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

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