A Retrospective Chart Review of Patients Treated With Ocriplasmin for Symptomatic VMA

NCT ID: NCT02193945

Last Updated: 2015-07-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 134 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2015-05-31

Brief Summary

The purpose of this study is to retrospectively review and further characterize anatomic and symptomatic changes over six months immediately following treatment of symptomatic vitreomacular adhesion (VMA) with JETREA® (ocriplasmin), including incidence, time to onset and resolution of anatomy and symptoms.

Detailed Description

This study (TG-MV-022) is a retrospective study utilizing Spectral-domain optical coherence tomography (SD-OCT) in patients treated previously with JETREA® for VMA. The objectives of this study are to retrospectively review and further characterize anatomic and symptomatic changes over six months immediately following treatment of VMA with JETREA® (ocriplasmin), including incidence, time to onset and resolution of anatomy and symptoms. The retrospective study will collect Heidelberg Spectralis® SD-OCT images which will be masked and uploaded to a Central Reading Center (CRC) for review and analysis. The CRC will evaluate anatomic endpoints of interest from both baseline optical coherence tomography (OCT) images and all follow-up OCT scans over the 6 month follow up period. Endpoints of interest include ellipsoid zone disruption, development of subretinal fluid, resolution of VMA and macular hole changes. Further, trained clinical personnel at the participating centers will transcribe data from the patients' records, to be entered into the study database.

Conditions

Symptomatic Vitreomacular Adhesion (VMA)

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

Inclusion Criteria

1. Must be at least 18 years of age or older.

2. Have been treated with JETREA® for vitreomacular adhesion (VMA) between April 1, 2013 and December 31, 2013 with at least six months of follow up visits post injection. Note: If a patient's second eye was treated, only the first eye treated is eligible for study participation.

3. Have been imaged with Heidelberg Spectralis SD-OCT at least one time within 30 days prior to JETREA® injection.

4. Have been imaged with Heidelberg Spectralis SD-OCT at least two times post JETREA® injection with at least one scan between Days 1-21 and the second scan within six months,, including a corresponding visual acuity (VA).

5. Be willing and able to provide informed consent.

Exclusion Criteria

1. Patients treated with JETREA® for medical conditions outside of the product label.

2. Patients with other retinal conditions that affect the vitreo-retinal interface, or can lead to retinal atrophy, including but not limited to:

• Neovascular age-related macular degeneration;
• Fibrovascular scar;
• Diabetic macular edema; and
• Proliferative diabetic retinopathy.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ThromboGenics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Retinal Diagnostic Center

Campbell, California, United States

Scripps Clinic

La Jolla, California, United States

Orange County Retina Medical Group

Santa Ana, California, United States

California Retina Consultants

Santa Barbara, California, United States

Retina Vitreous Associates of Florida

St. Petersburg, Florida, United States

Marietta Eye Clinic

Marietta, Georgia, United States

Rush university medical center-Dept ophthalmology

Chicago, Illinois, United States

Carle Foundation Hospital

Urbana, Illinois, United States

Sabates Eye Centers

Leawood, Kansas, United States

Carl W. Baker

Paducah, Kentucky, United States

Ophthalmic Consultants of Boston

Boston, Massachusetts, United States

Harvard Vanguard Medical Associates

Boston, Massachusetts, United States

Sierra Eye Associates

Reno, Nevada, United States

Eyesight Ophthalmic Services

Portsmouth, New Hampshire, United States

MaculaCare

New York, New York, United States

Duke University Eye Center

Durham, North Carolina, United States

Wills Eye Institute

Philadelphia, Pennsylvania, United States

Black Hills Regional Eye Institute

Rapid City, South Dakota, United States

Southeastern Retina Associates, P.C.

Kingsport, Tennessee, United States

Retina Consultants of Houston

Houston, Texas, United States

Valley Retina Institute, PA

McAllen, Texas, United States

Retina Specialists

Plano, Texas, United States

Retina Associates of Utah, P.C.

Salt Lake City, Utah, United States

West Virginia University Eye Institute

Morgantown, West Virginia, United States

Countries

United States

Other Identifiers

TG-MV-022

Identifier Type: -

Identifier Source: org_study_id