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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.
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| Measure | Description | 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 |
| 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 | |
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Inclusion Criteria:
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:
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Patients who have been treated with JETREA® for Symptomatic vitreomacular adhesion (VMA)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retinal Diagnostic Center | Campbell | California | 95008 | United States | ||
| Scripps Clinic |
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| 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 |
| Up to 6 months |
| Monitoring of Adverse Drug Reactions (ADRs) | Up to 6 motnths |
| La Jolla |
| California |
| 92037 |
| United States |
| Orange County Retina Medical Group | Santa Ana | California | 92705 | United States |
| California Retina Consultants | Santa Barbara | California | 93103 | United States |
| Retina Vitreous Associates of Florida | St. Petersburg | Florida | 33711 | United States |
| Marietta Eye Clinic | Marietta | Georgia | 30060 | United States |
| Rush university medical center-Dept ophthalmology | Chicago | Illinois | 60612 | United States |
| Carle Foundation Hospital | Urbana | Illinois | 61801 | United States |
| Sabates Eye Centers | Leawood | Kansas | 66211 | United States |
| Carl W. Baker | Paducah | Kentucky | 42001 | United States |
| Ophthalmic Consultants of Boston | Boston | Massachusetts | 02114 | United States |
| Harvard Vanguard Medical Associates | Boston | Massachusetts | 02215 | United States |
| Sierra Eye Associates | Reno | Nevada | 89502 | United States |
| Eyesight Ophthalmic Services | Portsmouth | New Hampshire | 03801 | United States |
| MaculaCare | New York | New York | 10021 | United States |
| Duke University Eye Center | Durham | North Carolina | 27710 | United States |
| Wills Eye Institute | Philadelphia | Pennsylvania | 19107 | United States |
| Black Hills Regional Eye Institute | Rapid City | South Dakota | 57701 | United States |
| Southeastern Retina Associates, P.C. | Kingsport | Tennessee | 37660 | United States |
| Retina Consultants of Houston | Houston | Texas | 77030 | United States |
| Valley Retina Institute, PA | McAllen | Texas | 78503 | United States |
| Retina Specialists | Plano | Texas | 75075 | United States |
| Retina Associates of Utah, P.C. | Salt Lake City | Utah | 84107 | United States |
| West Virginia University Eye Institute | Morgantown | West Virginia | 26506 | United States |