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

Completed · Phase 4

Conditions studied: Neovascular Age Related Macular Degeneration

In brief

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

Key facts

Study ID

NCT01863199

Run by

Retinal Consultants of Arizona

People needed

60

Starts

2013-05-01

Expected to finish

2015-12-01

Last updated by the study team

2017-10-04

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Retinal Consultants of Arizona — Gilbert, Arizona, United States
• Retinal Consultants of Arizona — Mesa, Arizona, United States
• Retinal Consultants of Arizona — Peoria, Arizona, United States
• Retinal Consultants of Arizona — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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