Assessment of Patients Treated With JETREA® for Vitreomacular Traction
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
First received: January 11, 2014
Last updated: February 10, 2015
Last verified: February 2015
The purpose of this study is to observe the anatomical and functional outcomes of ocriplasmin (JETREA®) over a 6-month follow-up period.
Drug: Ocriplasmin 0.125 mg in a 0.1 mL volume
||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Assessment of Anatomical and Functional Outcomes in Patients Treated With Ocriplasmin for Vitreomacular Traction/Symptomatic Vitreomacular Adhesion (VMT/sVMA)
Primary Outcome Measures:
- Proportion of subjects with nonsurgical resolution of focal vitreomacular traction (VMT/VMA) at Day 28, as determined by Central Reading Center (CRC) Spectral Domain Optical Coherence Tomography (SD‐OCT) evaluation [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change from baseline in best-corrected visual acuity (BCVA) at distance [ Time Frame: Baseline (Day 0), up to Day 180 ] [ Designated as safety issue: No ]
- Proportion of subjects with closure of macular hole (MH), if present at baseline [ Time Frame: Up to Day 180 ] [ Designated as safety issue: No ]
- Proportion of subjects with nonsurgical resolution of VMT/sVMA [ Time Frame: Up to Day 180 ] [ Designated as safety issue: No ]
- Proportion of subjects experiencing pars plana vitrectomy (PPV) at Day 180 [ Time Frame: Day 180 ] [ Designated as safety issue: No ]
- Change from baseline in central foveal thickness [ Time Frame: Up to Day 180 ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||September 2015 (Final data collection date for primary outcome measure)
Ocriplasmin 0.125 mg in a 0.1 mL volume administered as a single dose by intravitreal injection
Drug: Ocriplasmin 0.125 mg in a 0.1 mL volume
Other Name: JETREA®
Subjects will be recruited from approximately 90 centers in approximately 11 countries across Europe and Canada. After receiving a single intravitreal injection as per country's product label (Day 0), subjects will be followed for a 6-month period (Day 180).
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Diagnosis of vitreomacular traction/symptomatic vitreomacular adhesion (VMT/sVMA), with evidence of focal VMT visible on Spectral Domain Optical Coherence Tomography (SD-OCT).
- Read, sign, and date an Institutional Review Board/Ethics Committee-approved informed consent form.
- Other protocol-defined inclusion criteria may apply.
- Women of childbearing potential if pregnant, breastfeeding, or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study.
- Hypersensitivity to ocriplasmin or any of the JETREA excipients.
- Active or suspected intraocular or periocular infection.
- Presence of Epiretinal Membrane (ERM) over the macula at baseline.
- Broad VMT/VMA >1500 microns at baseline.
- History of vitrectomy in the study eye.
- History of laser photocoagulation to the macula in the study eye.
- Any relevant concomitant ocular condition that, in the opinion of the investigator, could be expected to worsen or require surgical intervention during the study period.
- Macular hole of >400µm diameter in the study eye.
- High myopia in the study eye.
- Pseudo-exfoliation, Marfan's syndrome, phacodonesis or any other finding in the Investigator's opinion suggesting lens/zonular instability.
- History of retinal detachment.
- Diabetic retinopathy, ischaemic retinopathies, retinal vein occlusions.
- Recent ocular surgery or ocular injection.
- Vitreous hemorrhage.
- Exudative age-related macular degeneration (AMD).
- Therapy with another investigational agent within 30 days prior to Visit 1.
- Active, simultaneous enrollment in another ophthalmology clinical study.
- Other protocol-defined exclusion criteria may apply.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02035748
|Contact Alcon Call Center for Trial Locations
|Fort Worth, Texas, United States, 76134 |
||Danyel C Carr, MS, CCRA
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 11, 2014
||February 10, 2015
||European Union: European Medicines Agency
Belgium: Ethics Committee
Canada: Ethics Review Committee
France: Committee for the Protection of Personnes
Germany: Ethics Commission
Hungary: Institutional Ethics Committee
Italy: Ethics Committee
Netherlands: Independent Ethics Committee
Poland: Ethics Committee
Portugal: Ethics Committee
Spain: Ethics Committee
United Kingdom: Research Ethics Committee
Keywords provided by Alcon Research:
Symptomatic vitreomacular adhesion
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 01, 2015