A Retrospective Chart Review of Patients Treated With Ocriplasmin for Symptomatic VMA
- Conditions
- Symptomatic Vitreomacular Adhesion (VMA)
- Registration Number
- NCT02193945
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 134
- 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.
-
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
Name Time Method Time to resolution of VMA Up to 6 months 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 with nonsurgical resolution of VMA by Day 28 Day 28 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 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 * 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 changesMonitoring of Adverse Drug Reactions (ADRs) Up to 6 motnths
Trial Locations
- Locations (24)
Southeastern Retina Associates, P.C.
🇺🇸Kingsport, Tennessee, United States
Retinal Diagnostic Center
🇺🇸Campbell, 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
Harvard Vanguard Medical Associates
🇺🇸Boston, Massachusetts, United States
Ophthalmic Consultants of Boston
🇺🇸Boston, Massachusetts, United States
Sierra Eye Associates
🇺🇸Reno, Nevada, United States
Eyesight Ophthalmic Services
🇺🇸Portsmouth, New Hampshire, United States
MaculaCare
🇺🇸New York, New York, United States
Black Hills Regional Eye Institute
🇺🇸Rapid City, South Dakota, United States
Wills Eye Institute
🇺🇸Philadelphia, Pennsylvania, United States
Retina Consultants of Houston
🇺🇸Houston, Texas, United States
Valley Retina Institute, PA
🇺🇸McAllen, Texas, United States
Retina Specialists
🇺🇸Plano, Texas, United States
West Virginia University Eye Institute
🇺🇸Morgantown, West Virginia, United States
Duke University Eye Center
🇺🇸Durham, North Carolina, United States
Retina Associates of Utah, P.C.
🇺🇸Salt Lake City, Utah, United States
Scripps Clinic
🇺🇸La Jolla, California, United States