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

NCT01863199 | Completed Phase 4

• 1 other identifier: ML28727
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Neovascular Age Related Macular Degeneration

Keywords

Wet AMD; AMD; Choroidal neovascularization; Neovascular membrane

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Central foveal thickness

  12 months

Other Outcomes (2)

• Number of office visits needed

  12 months

• Number of required injections

  12 months

Study Arms (3)

Lucentis every 4 weeks

ACTIVE COMPARATOR

Lucentis 0.5mg administered intravitreally every four weeks for 12 months

Drug: Lucentis every 4 weeks

Lucentis every 12 weeks

ACTIVE COMPARATOR

Lucentis 0.5mg administered intravitreally every 12 weeks

Drug: Lucentis every 12 weeks

Treat and extend

EXPERIMENTAL

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)

Interventions

Lucentis (Treat and extend) DRUG

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

Treat and extend

Lucentis every 4 weeks DRUG

Lucentis 0.5mg administered intravitreally every four weeks for 12 months

Lucentis every 4 weeks

Lucentis every 12 weeks DRUG

Lucentis 0.5mg administered intravitreally every twelve weeks for 12 months

Lucentis every 12 weeks

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Retinal Consultants of Arizona: lead
• Genentech, Inc.: collaborator

Study Sites (4)

Retinal Consultants of Arizona

Gilbert, Arizona, 85296, United States

Location

Retinal Consultants of Arizona

Mesa, Arizona, 85210, United States

Location

Retinal Consultants of Arizona

Peoria, Arizona, 85381, United States

Location

Retinal Consultants of Arizona

Phoenix, Arizona, 85014, United States

Location

MeSH Terms

Conditions

Choroidal Neovascularization

Interventions

Ranibizumab; Coal Tar

Condition Hierarchy (Ancestors)

Choroid Diseases; Uveal Diseases; Eye Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Tars; Complex Mixtures

Study Officials

• Pravin U Dugel, MD

  Retinal Consultants of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2013
• First Posted: May 27, 2013
• Study Start: May 1, 2013
• Primary Completion: November 1, 2015
• Study Completion: December 1, 2015
• Last Updated: October 4, 2017

Record last verified: 2017-10

Locations

US (4)