Clinical trial NCT02193945: A Retrospective Chart Review of Patients Treated With Ocriplasmin for Symptomatic VMA
Official title: OZONE: Ocriplasmin Ellipsoid Zone Retrospective Data Collection Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Symptomatic Vitreomacular Adhesion (VMA)
Lead sponsor: ThromboGenics
Sponsor class: INDUSTRY
First posted: 2014-07-18
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who have been treated with JETREA® for Symptomatic vitreomacular adhesion (VMA)

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.

Eligibility 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.

Primary outcomes:
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.
timeFrame: Day 21
Secondary outcomes:
measure: Proportion of patients with ellipsoid zone disruption, not present at baseline
timeFrame: Up to 6 months
measure: Proportion of patients with ellipsoid zone disruption with resolution
timeFrame: Up to 6 months
measure: Time to onset of ellipsoid zone disruption
timeFrame: Up to 6 months
measure: Time to resolution of ellipsoid zone disruption
timeFrame: Up to 6 months
measure: Proportion of patients that developed subretinal fluid, not present at baseline
timeFrame: Up to 6 months
measure: Proportion of patients that developed subretinal fluid with resolution
timeFrame: Up to 6 months
measure: Time to onset of subretinal fluid
timeFrame: Up to 6 months
measure: Time to resolution of subretinal fluid
timeFrame: Up to 6 months
measure: Proportion of patients with nonsurgical resolution of VMA by Day 28
timeFrame: Day 28
measure: Time to resolution of VMA
timeFrame: Up to 6 months
measure: Proportion of patients that developed a macular hole by Day 28, not present at baseline
timeFrame: Day 28
measure: Proportion of patients with nonsurgical closure of macular hole, if present at baseline by Day 28
timeFrame: Day 28
measure: Proportion of patients with worsening (enlargement) of macular hole, if present at baseline
timeFrame: Up to 6 months
measure: No change of macular hole, if present at baseline
timeFrame: Up to 6 months
measure: Proportion of patients that underwent vitrectomy
timeFrame: Up to 6 months
measure: Visual Acuity (VA) changes from baseline
timeFrame: Up to 6 months
measure: Other findings as examined and documented in the patient's medical records
timeFrame: Up to 6 months
measure: Monitoring of Adverse Drug Reactions (ADRs)
timeFrame: Up to 6 motnths
Other outcomes:
Locations:
city: Campbell
country: United States
facility: Retinal Diagnostic Center
state: California
city: La Jolla
country: United States
facility: Scripps Clinic
state: California
city: Santa Ana
country: United States
facility: Orange County Retina Medical Group
state: California
city: Santa Barbara
country: United States
facility: California Retina Consultants
state: California
city: St. Petersburg
country: United States
facility: Retina Vitreous Associates of Florida
state: Florida
city: Marietta
country: United States
facility: Marietta Eye Clinic
state: Georgia
city: Chicago
country: United States
facility: Rush university medical center-Dept ophthalmology
state: Illinois
city: Urbana
country: United States
facility: Carle Foundation Hospital
state: Illinois
city: Leawood
country: United States
facility: Sabates Eye Centers
state: Kansas
city: Paducah
country: United States
facility: Carl W. Baker
state: Kentucky
city: Boston
country: United States
facility: Ophthalmic Consultants of Boston
state: Massachusetts
city: Boston
country: United States
facility: Harvard Vanguard Medical Associates
state: Massachusetts
city: Reno
country: United States
facility: Sierra Eye Associates
state: Nevada
city: Portsmouth
country: United States
facility: Eyesight Ophthalmic Services
state: New Hampshire
city: New York
country: United States
facility: MaculaCare
state: New York
city: Durham
country: United States
facility: Duke University Eye Center
state: North Carolina
city: Philadelphia
country: United States
facility: Wills Eye Institute
state: Pennsylvania
city: Rapid City
country: United States
facility: Black Hills Regional Eye Institute
state: South Dakota
city: Kingsport
country: United States
facility: Southeastern Retina Associates, P.C.
state: Tennessee
city: Houston
country: United States
facility: Retina Consultants of Houston
state: Texas
city: McAllen
country: United States
facility: Valley Retina Institute, PA
state: Texas
city: Plano
country: United States
facility: Retina Specialists
state: Texas
city: Salt Lake City
country: United States
facility: Retina Associates of Utah, P.C.
state: Utah
city: Morgantown
country: United States
facility: West Virginia University Eye Institute
state: West Virginia
Study officials:
References: