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.
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
134
Retinal Diagnostic Center
Campbell, California, United States
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
Proportion of patients with ellipsoid zone disruption, not present at baseline
Time frame: Up to 6 months
Proportion of patients with ellipsoid zone disruption with resolution
Time frame: Up to 6 months
Time to onset of ellipsoid zone disruption
Time frame: Up to 6 months
Time to resolution of ellipsoid zone disruption
Time frame: Up to 6 months
Proportion of patients that developed subretinal fluid, not present at baseline
Time frame: Up to 6 months
Proportion of patients that developed subretinal fluid with resolution
Time frame: Up to 6 months
Time to onset of subretinal fluid
Time frame: Up to 6 months
Time to resolution of subretinal fluid
Time frame: Up to 6 months
Proportion of patients with nonsurgical resolution of VMA by Day 28
Time frame: Day 28
Time to resolution of VMA
Time frame: Up to 6 months
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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
...and 14 more locations
Proportion of patients that developed a macular hole by Day 28, not present at baseline
Time frame: Day 28
Proportion of patients with nonsurgical closure of macular hole, if present at baseline by Day 28
Time frame: Day 28
Proportion of patients with worsening (enlargement) of macular hole, if present at baseline
Time frame: Up to 6 months
No change of macular hole, if present at baseline
Time frame: Up to 6 months
Proportion of patients that underwent vitrectomy
Time frame: Up to 6 months
Visual Acuity (VA) changes from baseline
Time frame: 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
Time frame: Up to 6 months
Monitoring of Adverse Drug Reactions (ADRs)
Time frame: Up to 6 motnths