Phase 4
N=468
Assessment of Patients Treated With JETREA® for Vitreomacular Traction
Vitreomacular Traction · Vitreomacular Adhesion
Bottom Line
View on ClinicalTrials.gov: NCT02035748 ↗Enrolled (actual)
468
Serious AEs
4.3%
Results posted
Oct 2016
Primary outcome: Primary: 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 — 47.4 percentage of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ocriplasmin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
47.4 | — |
| SECONDARY Nonsurgical Change From Baseline in Best-corrected Visual Acuity (BCVA) at Distance |
1.7; 3.0; 3.5 | — |
| SECONDARY Proportion of Subjects With Nonsurgical Closure of Macular Hole (MH), if Present at Baseline |
39.5; 40.7; 41.9 | — |
| SECONDARY Proportion of Subjects With Nonsurgical Resolution of VMT/sVMA |
47.9; 49.4 | — |
| SECONDARY Proportion of Subjects Experiencing Pars Plana Vitrectomy (PPV) at Day 180 |
12.0 | — |
| SECONDARY Mean Nonsurgical Change From Baseline in Central Foveal Thickness (CFT) |
276.1; -43.2; -45.4 | — |
Summary
The purpose of this study is to observe the anatomical and functional outcomes of ocriplasmin (JETREA®) over a 6-month follow-up period.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of vitreomacular traction/symptomatic vitreomacular adhesion (VMT/sVMA), with evidence of focal VMA 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.
Exclusion Criteria
- 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.
- Aphakia.
- 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.
Data sourced from ClinicalTrials.gov (NCT02035748). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.