Symptomatic Vitreomacular Adhesion (VMA)OZONENCT02193945
A Retrospective Chart Review of Patients Treated With Ocriplasmin for Symptomatic VMA
An observational study of Symptomatic Vitreomacular Adhesion (VMA), run by ThromboGenics at 24 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Symptomatic Vitreomacular Adhesion (VMA)
- How many people
- 134 participants
- Where
- 24 sitesUnited States
- Study dates
- Aug 2014to May 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have been treated with JETREA® for Symptomatic vitreomacular adhesion (VMA)
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
United States24 sites
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114
Harvard Vanguard Medical Associates
Boston, Massachusetts, 02215
Retinal Diagnostic Center
Campbell, California, 95008
Rush university medical center-Dept ophthalmology
Chicago, Illinois, 60612
Duke University Eye Center
Durham, North Carolina, 27710
Retina Consultants of Houston
Houston, Texas, 77030
Southeastern Retina Associates, P.C.
Kingsport, Tennessee, 37660
Scripps Clinic
La Jolla, California, 92037
Sabates Eye Centers
Leawood, Kansas, 66211
Marietta Eye Clinic
Marietta, Georgia, 30060
Valley Retina Institute, PA
McAllen, Texas, 78503
West Virginia University Eye Institute
Morgantown, West Virginia, 26506
MaculaCare
New York, New York, 10021
Carl W. Baker
Paducah, Kentucky, 42001
Wills Eye Institute
Philadelphia, Pennsylvania, 19107
Retina Specialists
Plano, Texas, 75075
Eyesight Ophthalmic Services
Portsmouth, New Hampshire, 03801
Black Hills Regional Eye Institute
Rapid City, South Dakota, 57701
Sierra Eye Associates
Reno, Nevada, 89502
Retina Associates of Utah, P.C.
Salt Lake City, Utah, 84107
Orange County Retina Medical Group
Santa Ana, California, 92705
California Retina Consultants
Santa Barbara, California, 93103
Retina Vitreous Associates of Florida
St. Petersburg, Florida, 33711
Carle Foundation Hospital
Urbana, Illinois, 61801
About this study
Official title: OZONE: Ocriplasmin Ellipsoid Zone Retrospective Data Collection Study
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.
Read the 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.
- Conditions
- Symptomatic Vitreomacular Adhesion (VMA)
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 21
Secondary outcomes (18)
Proportion of patients with ellipsoid zone disruption, not present at baseline
Measured: Up to 6 months
Proportion of patients with ellipsoid zone disruption with resolution
Measured: Up to 6 months
Time to onset of ellipsoid zone disruption
Measured: Up to 6 months
Time to resolution of ellipsoid zone disruption
Measured: Up to 6 months
Proportion of patients that developed subretinal fluid, not present at baseline
Measured: Up to 6 months
Proportion of patients that developed subretinal fluid with resolution
Measured: Up to 6 months
Time to onset of subretinal fluid
Measured: Up to 6 months
Time to resolution of subretinal fluid
Measured: Up to 6 months
Proportion of patients with nonsurgical resolution of VMA by Day 28
Measured: Day 28
Time to resolution of VMA
Measured: Up to 6 months
Proportion of patients that developed a macular hole by Day 28, not present at baseline
Measured: Day 28
Proportion of patients with nonsurgical closure of macular hole, if present at baseline by Day 28
Measured: Day 28
Proportion of patients with worsening (enlargement) of macular hole, if present at baseline
Measured: Up to 6 months
No change of macular hole, if present at baseline
Measured: Up to 6 months
Proportion of patients that underwent vitrectomy
Measured: Up to 6 months
Visual Acuity (VA) changes from baseline
Measured: 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
Measured: Up to 6 months
Monitoring of Adverse Drug Reactions (ADRs)
Measured: Up to 6 motnths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2014 (estimated)
- Study startAug 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic Vitreomacular Adhesion (VMA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- ThromboGenics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02193945
- Sponsor's protocol ID
- TG-MV-022
- Acronym
- OZONE
- Status last verified
- Jul 2015
- First submitted
- 11 Jul 2014
- Last updated
- 9 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OZONE: Ocriplasmin Ellipsoid Zone Retrospective Data Collection Study
- ClinicalTrials.gov ID
- NCT02193945
- Acronym / sponsor ID
- OZONE / TG-MV-022
- Conditions
- Symptomatic Vitreomacular Adhesion (VMA)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- ThromboGenicsIndustry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 18 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have been treated with JETREA® for Symptomatic vitreomacular adhesion (VMA)
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
18 secondary outcomes
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
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
Time frame: Up to 6 months
Monitoring of Adverse Drug Reactions (ADRs)
Time frame: Up to 6 motnths
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Symptomatic Vitreomacular Adhesion (VMA), run by ThromboGenics at 24 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2015.