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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 (ROSE)

Primary Purpose

Wet Age-related Macular Degeneration

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

NeoVista Ophthalmic System

About this trial

This is an interventional treatment trial for Wet Age-related Macular Degeneration focused on measuring Macular, Degeneration, AMD, Wet Age-related macular degeneration

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Ophthalmic Consultants of Boston
Medical Center Ophthalmology Associates

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT00679445

First Posted

May 14, 2008

Last Updated

July 26, 2011

Sponsor

NeoVista

1. Study Identification

Unique Protocol Identification Number

NCT00679445

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2011

Overall Recruitment Status

Completed

Study Start Date

December 2007 (undefined)

Primary Completion Date

June 2011 (Actual)

Study Completion Date

June 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

NeoVista

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Wet Age-related Macular Degeneration

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

NeoVista Ophthalmic System

Intervention Description

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

Primary Outcome Measure Information:

Title

Time Frame

3 Year

Secondary Outcome Measure Information:

Title

Time Frame

3 Years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jeffrey S Heier, MD

Organizational Affiliation

Ophthalmic Consultants of Boston

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jeffrey A Nau, MMS

Organizational Affiliation

NeoVista, Inc

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Michael Singer, MD

Organizational Affiliation

Medical Center Ophthalmology Associates

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ophthalmic Consultants of Boston

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

Medical Center Ophthalmology Associates

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78240

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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