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

Phase 4

Completed

• Conditions: Neovascular Age Related Macular Degeneration
• Interventions: Drug: Lucentis every 4 weeks; Drug: Lucentis every 12 weeks; Drug: Lucentis (Treat and extend)

• Registration Number: NCT01863199
• Lead Sponsor: Retinal Consultants of Arizona

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.

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-20
• Study First Submitted QC: 2013-05-24
• Study First Posted: 2013-05-27
• Primary Completion: 2015-11
• Study Completion: 2015-12
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-02
• Last Update Posted: 2017-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lucentis every 4 weeks	Lucentis every 4 weeks	Lucentis 0.5mg administered intravitreally every four weeks for 12 months
Lucentis every 12 weeks	Lucentis every 12 weeks	Lucentis 0.5mg administered intravitreally every 12 weeks
Treat and extend	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

Name	Time	Method
Best corrected visual acuity	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

Name	Time	Method
Central foveal thickness	12 months	Central foveal thickness as determined by Spectral Domain-Ocular Coherence Tomography (SD-OCT).

Trial Locations

Locations (1)

Retinal Consultants of Arizona; 🇺🇸 Phoenix, Arizona, United States