A 16 Week Evaluation of the Novartis Health Management Tool (HMT) in Age Related Macular Degeneration (AMD)

Novartis

Status: Completed

Conditions: Age Related Macular Degeneration (AMD)

Treatments: Other: Health Management Tool (HMT)

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT01542866

CRFB002A2407

Details and patient eligibility

About

This is a prospective pilot study to evaluate the usability and applicability of a self monitoring test of visual function with the handheld Health Management Tool (HMT) to remotely monitor neovascular Age Related Macular Degeneration (AMD) to detect a potential change in disease status.

Enrollment: 160 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with CNV secondary to AMD and not other causes in at least one eye identified by the investigator to be eligible for ranibizumab treatment
• Patients with a BCVA letter score in the study eye is 24 or better using an ETDRS chart measured at 4 meters distance

Exclusion criteria

• Patients with any concurrent ocular condition that may result in visual loss during the study
• Patients with past (within the prior 6 months) or current use of, or likely need for, systemic medications that are known to be toxic to the lens, retina, or optic nerve
• Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

160 participants in 1 patient group

Home Monitoring Test

Experimental group

Description:

Health management tool (HMT) for measuring vision impairment

Treatment:

Other: Health Management Tool (HMT)