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

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ClinicalTrials.gov Identifier: NCT02193945
Recruitment Status : Completed
First Posted : July 18, 2014
Last Update Posted : July 9, 2015
Sponsor:
Information provided by (Responsible Party):
ThromboGenics

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.

Condition or disease
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
Actual Enrollment : 134 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: OZONE: Ocriplasmin Ellipsoid Zone Retrospective Data Collection Study
Study Start Date : August 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ozone




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients who have been treated with JETREA® for Symptomatic vitreomacular adhesion (VMA)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02193945


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Sponsors and Collaborators
ThromboGenics

Responsible Party: ThromboGenics
ClinicalTrials.gov Identifier: NCT02193945     History of Changes
Other Study ID Numbers: TG-MV-022
First Posted: July 18, 2014    Key Record Dates
Last Update Posted: July 9, 2015
Last Verified: July 2015