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

OZONE: Ocriplasmin Ellipsoid Zone Retrospective Data Collection Study

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.

Study Overview

• Status: Completed
• Conditions: Symptomatic Vitreomacular Adhesion (VMA)

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.

• Study Type: Observational
• Enrollment (Actual): 134

Contacts and Locations

Study Locations

• United States
  • California
    • Campbell, California, United States, 95008
      • Retinal Diagnostic Center
    • La Jolla, California, United States, 92037
      • Scripps Clinic
    • Santa Ana, California, United States, 92705
      • Orange County Retina Medical Group
    • Santa Barbara, California, United States, 93103
      • California Retina Consultants
  • Florida
    • St. Petersburg, Florida, United States, 33711
      • Retina Vitreous Associates of Florida
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Marietta Eye Clinic
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush university medical center-Dept ophthalmology
    • Urbana, Illinois, United States, 61801
      • Carle Foundation Hospital
  • Kansas
    • Leawood, Kansas, United States, 66211
      • Sabates Eye Centers
  • Kentucky
    • Paducah, Kentucky, United States, 42001
      • Carl W. Baker
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Ophthalmic Consultants of Boston
    • Boston, Massachusetts, United States, 02215
      • Harvard Vanguard Medical Associates
  • Nevada
    • Reno, Nevada, United States, 89502
      • Sierra Eye Associates
  • New Hampshire
    • Portsmouth, New Hampshire, United States, 03801
      • Eyesight Ophthalmic Services
  • New York
    • New York, New York, United States, 10021
      • MaculaCare
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Eye Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Wills Eye Institute
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Black Hills Regional Eye Institute
  • Tennessee
    • Kingsport, Tennessee, United States, 37660
      • Southeastern Retina Associates, P.C.
  • Texas
    • Houston, Texas, United States, 77030
      • Retina Consultants of Houston
    • McAllen, Texas, United States, 78503
      • Valley Retina Institute, PA
    • Plano, Texas, United States, 75075
      • Retina Specialists
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Retina Associates of Utah, P.C.
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • West Virginia University Eye Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients who have been treated with JETREA® for Symptomatic vitreomacular adhesion (VMA)

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients with ellipsoid zone disruption by Day 21 post-JETREA® injection, determined by a Central Reading Center (CRC), that was not present at baseline.	Day 21

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with ellipsoid zone disruption, not present at baseline		Up to 6 months
Proportion of patients with ellipsoid zone disruption with resolution		Up to 6 months
Time to onset of ellipsoid zone disruption		Up to 6 months
Time to resolution of ellipsoid zone disruption		Up to 6 months
Proportion of patients that developed subretinal fluid, not present at baseline		Up to 6 months
Proportion of patients that developed subretinal fluid with resolution		Up to 6 months
Time to onset of subretinal fluid		Up to 6 months
Time to resolution of subretinal fluid		Up to 6 months
Proportion of patients with nonsurgical resolution of VMA by Day 28		Day 28
Time to resolution of VMA		Up to 6 months
Proportion of patients that developed a macular hole by Day 28, not present at baseline		Day 28
Proportion of patients with nonsurgical closure of macular hole, if present at baseline by Day 28		Day 28
Proportion of patients with worsening (enlargement) of macular hole, if present at baseline		Up to 6 months
No change of macular hole, if present at baseline		Up to 6 months
Proportion of patients that underwent vitrectomy		Up to 6 months
Visual Acuity (VA) changes from baseline		Up to 6 months
Other findings as examined and documented in the patient's medical records	Impaired pupillary reflex; Dyschromatopsia; ERG changes; Vascular changes; Visual field constriction; Lens changes post- JETREA® injection including, subluxation, dislocation, phacodenesis; Other changes in quality of vision including, darkness of vision, dark adaptation changes	Up to 6 months
Monitoring of Adverse Drug Reactions (ADRs)		Up to 6 motnths

Collaborators and Investigators

• Sponsor: ThromboGenics

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (ACTUAL): May 1, 2015
• Study Completion (ACTUAL): May 1, 2015

Study Registration Dates

• First Submitted: July 11, 2014
• First Submitted That Met QC Criteria: July 16, 2014
• First Posted (ESTIMATE): July 18, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): July 9, 2015
• Last Update Submitted That Met QC Criteria: July 8, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix; Tissue Adhesions
• Other Study ID Numbers: TG-MV-022