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Completed

NCT Number: NCT02193945

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

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.

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Key information

Conditions

Symptomatic Vitreomacular Adhesion (VMA)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Retinal Diagnostic Center, Campbell, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must be at least 18 years of age or older.
  • 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.
  • Have been imaged with Heidelberg Spectralis SD-OCT at least one time within 30 days prior to JETREA® injection.
  • 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).
  • Be willing and able to provide informed consent.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. 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.

    Time frame: Day 21

Secondary outcomes

  1. Proportion of patients with ellipsoid zone disruption, not present at baseline

    Time frame: Up to 6 months

  2. Proportion of patients with ellipsoid zone disruption with resolution

    Time frame: Up to 6 months

  3. Time to onset of ellipsoid zone disruption

    Time frame: Up to 6 months

  4. Time to resolution of ellipsoid zone disruption

    Time frame: Up to 6 months

  5. Proportion of patients that developed subretinal fluid, not present at baseline

    Time frame: Up to 6 months

  6. Proportion of patients that developed subretinal fluid with resolution

    Time frame: Up to 6 months

  7. Time to onset of subretinal fluid

    Time frame: Up to 6 months

  8. Time to resolution of subretinal fluid

    Time frame: Up to 6 months

  9. Proportion of patients with nonsurgical resolution of VMA by Day 28

    Time frame: Day 28

  10. Time to resolution of VMA

    Time frame: Up to 6 months

  11. Proportion of patients that developed a macular hole by Day 28, not present at baseline

    Time frame: Day 28

  12. Proportion of patients with nonsurgical closure of macular hole, if present at baseline by Day 28

    Time frame: Day 28

  13. Proportion of patients with worsening (enlargement) of macular hole, if present at baseline

    Time frame: Up to 6 months

  14. No change of macular hole, if present at baseline

    Time frame: Up to 6 months

  15. Proportion of patients that underwent vitrectomy

    Time frame: Up to 6 months

  16. Visual Acuity (VA) changes from baseline

    Time frame: Up to 6 months

  17. Other findings as examined and documented in the patient's medical records

    Time frame: Up to 6 months

    • 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

  18. Monitoring of Adverse Drug Reactions (ADRs)

    Time frame: Up to 6 motnths

Sponsors and collaborators

Lead sponsor

ThromboGenics

Industry

Registry information

Official study title

OZONE: Ocriplasmin Ellipsoid Zone Retrospective Data Collection Study

Acronym: OZONE

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 18, 2014
Registry last updated
Jul 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.