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

Wet Age-related Macular Degeneration Clinical Trial

— ROSE  

Official title:

A Feasibility Study to Evaluate the Safety And Tolerability of the EPI-RAD90™ Ophthalmic System for the Treatment of Subfoveal Choroidal Neovascularization (CNV) in Patients With Age-Related Macular Degeneration (AMD) That Have Failed Primary Anti-VEGF Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00679445
• Other study ID #: NVI-006
• Status: Completed
• Phase: Phase 2
• First received: May 14, 2008
• Last updated: July 26, 2011
• Start date: December 2007
• Est. completion date: June 2011

Study information

• Verified date: July 2011
• Source: NeoVista
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Choroidal Neovascularization
• Macular Degeneration
• Wet Age-related Macular Degeneration

Intervention

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

Locations

Country	Name	City	State
United States	Ophthalmic Consultants of Boston	Boston	Massachusetts
United States	Medical Center Ophthalmology Associates	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
NeoVista

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No