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

NCT00679445 | Completed Phase 2

• 1 other identifier: NVI-006
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Wet Age-related Macular Degeneration

Keywords

Macular; Degeneration; AMD; Wet Age-related macular degeneration

Outcome Measures

Primary Outcomes (1)

• Safety Parameters to be evaluated include incidence and severity of ocular adverse events identified by eye examinations, including visual acuity. Retinal thickness will also be measured, and stereo fundus photography will be reviewed.

  3 Year

Secondary Outcomes (1)

• Efficacy Assessment: Preliminary efficacy will be evaluated by measuring best-corrected visual acuity (ETDRS) and AMD lesion size and leakage as assessed by fluorescein angiography at 1, 2, 3, 6, 12, 18, 24, and 36 months in the study eye.

  3 Years

Study Arms (1)

A

EXPERIMENTAL

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

Device: NeoVista Ophthalmic System

Interventions

NeoVista Ophthalmic System DEVICE

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

A

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• NeoVista: lead

Study Sites (2)

Ophthalmic Consultants of Boston

Boston, Massachusetts, 02114, United States

Location

Medical Center Ophthalmology Associates

San Antonio, Texas, 78240, United States

Location

Study Officials

• Jeffrey S Heier, MD

  Ophthalmic Consultants of Boston

  PRINCIPAL INVESTIGATOR

• Jeffrey A Nau, MMS

  NeoVista, Inc

  STUDY DIRECTOR

• Michael Singer, MD

  Medical Center Ophthalmology Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 14, 2008
• First Posted: May 16, 2008
• Study Start: December 1, 2007
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: July 27, 2011

Record last verified: 2011-07

Locations

US (2)