A Study to Evaluate the Neovista Ophthalmic System for the Treatment of Subfoveal CNV in Patients With AMD That Have Failed Primary Anti-VEGF Therapy

NCT ID: NCT00679445

Last Updated: 2011-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2011-06-30

Brief Summary

The objective of this clinical study is to evaluate the safety and feasibility of focal delivery of radiation for the treatment of subfoveal choroidal neovascularization (CNV) in patients with age related macular degeneration that have failed Primary Anti-VEGF therapy.

Detailed Description

Therapeutic advances in the arena of neovascular age-related macular degeneration (AMD) have provided multiple treatment options for the disease. Radiotherapy has been studied in multiple clinical trials in the past with many studies showing a therapeutic benefit. Treatment with radiotherapy and anti-VEGF compounds is a promising approach to treating AMD.

Conditions

Wet Age-related Macular Degeneration

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

Device: NeoVista Ophthalmic System A single procedure using the NeoVista Ophthalmic System plus an injection of Lucentis.

Group Type: EXPERIMENTAL

NeoVista Ophthalmic System

Intervention Type: DEVICE

A single procedure using the NeoVioasta Ophthalmic System plus an injection of Lucentis.

Interventions

NeoVista Ophthalmic System

A single procedure using the NeoVioasta Ophthalmic System plus an injection of Lucentis.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Subjects must have predominantly classic, minimally classic, or occult with no classic lesions, as determined by the Investigator, secondary to AMD, with a total lesion size (including blood, scarring, and neovascularization) of < 12 total disc areas (21.24 mm2), and a GLD ≤5.4 mm
• Subjects must have received a minimum of three (3) prior injections (a minimum of 3 prior injections of the same compound) of anti-VEGF therapy (Lucentis® or Avastin®, subjects may have been treated previously with Macugen®, but must have been most recently treated with Lucentis® or Avastin® and met the criteria for failure below) with evidence of "failure" to respond to therapy
• Subjects must be age 50 or older

Exclusion Criteria

• Subjects with prior or subfoveal CNV therapy with photodynamic therapy, intravitreal or subretinal steroids, or transpupillary thermotherapy (TTT) (Note: This includes subjects with no known history, but with photographic evidence of prior therapy)
• Subjects who underwent previous radiation therapy to the eye, head or neck
• Subjects who have been previously diagnosed with Type 1 or Type 2 diabetes mellitus. Subjects who do not have a documented diagnosis but have retinal findings consistent with Type 1 or Type 2 Diabetes Mellitus.
• Women of child-bearing potential (female subjects must be post menopausal or surgically sterilized)

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NeoVista

INDUSTRY

Sponsor Role: lead

Responsible Party

NeoVista Incorporated

Principal Investigators

Jeffrey S Heier, MD

Role: PRINCIPAL_INVESTIGATOR

Ophthalmic Consultants of Boston

Jeffrey A Nau, MMS

Role: STUDY_DIRECTOR

NeoVista, Inc

Michael Singer, MD

Role: PRINCIPAL_INVESTIGATOR

Medical Center Ophthalmology Associates

Locations

Ophthalmic Consultants of Boston

Boston, Massachusetts, United States

Medical Center Ophthalmology Associates

San Antonio, Texas, United States

Countries

United States

Other Identifiers

NVI-006

Identifier Type: -

Identifier Source: org_study_id