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

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Retinal Consultants of Arizona
• Collaborator: Genentech, Inc.
• Treatments: Ranibizumab

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