Vitreomacular TractionPhase 4NCT02035748
Assessment of Patients Treated With JETREA® for Vitreomacular Traction
A Phase 4 study testing Ocriplasmin in people with Vitreomacular Traction and Vitreomacular Adhesion, run by Alcon Research.
Trial summary
The purpose of this study is to observe the anatomical and functional outcomes of ocriplasmin (JETREA®) over a 6-month follow-up period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitreomacular Traction, Vitreomacular Adhesion
- What is being tested?
- Ocriplasmin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 628 participants
- Where
- No sites listed yet
- Study dates
- Apr 2014to Sep 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 20Show fewer
- 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.
About this study
Official title: Assessment of Anatomical and Functional Outcomes in Patients Treated With Ocriplasmin for Vitreomacular Traction/Symptomatic Vitreomacular Adhesion (VMT/sVMA)
The purpose of this study is to observe the anatomical and functional outcomes of ocriplasmin (JETREA®) over a 6-month follow-up period.
Read the detailed description
After receiving a single intravitreal injection as per country's product label (Day 0), subjects were followed for a 6-month period (Day 180).
- Conditions
- Vitreomacular Traction, Vitreomacular Adhesion
- Being tested
- Ocriplasmin
- Keywords
- Vitreomacular traction, Symptomatic vitreomacular adhesion, Ocriplasmin, JETREA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OcriplasminDrug
Also called JETREA®
0.5 mg/0.2 mL solution for injection
| Study group | Role | What they receive |
|---|---|---|
| Ocriplasmin | Experimental | Ocriplasmin 0.125 mg in a 0.1 mL volume administered as a single dose by intravitreal injection Receives: Drug: Ocriplasmin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Vitreous separation was assessed by SD-OCT using scores ranging from 1 (vitreous attached from macula to ON; separated elsewhere cannot determine foveal) to 12 (unable to determine state of separation). Nonsurgical resolution was defined as a change from baseline score of 5/6/8 to 7/9/10 at Day 28. The assessment of resolution of VMT/sVMA was based upon the anatomical resolution of VMA only, i.e. no resolution of the related symptoms was considered. Thus, the term VMA is used interchangeably with VMT/sVMA. Proportion of subjects is presented as a percentage, with percentage based on the number of subjects who have VMT/sVMA at baseline and SD-OCT value at Day 28. One eye (study eye) contributed to the analysis.
Measured: Baseline, Day 28
Secondary outcomes (5)
Nonsurgical Change From Baseline in Best-corrected Visual Acuity (BCVA) at Distance
BCVA (with spectacles or other visual corrective devices) was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) testing at 4 meters. The charts contain 14 rows of letters. BCVA was calculated as the number of letters read correctly and improvement defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis.
Measured: Baseline (Day 0), Day 28, Day 90, Day 180
Proportion of Subjects With Nonsurgical Closure of Macular Hole (MH), if Present at Baseline
The closure of macular hole (a full thickness defect of the retinal tissue involving the anatomical fovea) is defined as a flattened and reattached hole rim along the whole circumference of macular hole. Closure was determined by SD-OCT evaluation and the percentage of subjects tabulated. Proportion of subjects is presented as a percentage, with percentage based on the number of subjects who had macular hole at baseline and OCT value at each specific visit. One eye (study eye) contributed to the analysis.
Measured: Day 28, Day 90, Day 180
Proportion of Subjects With Nonsurgical Resolution of VMT/sVMA
Vitreous separation was assessed by SD-OCT using scores ranging from 1 (vitreous attached from macula to ON; separated elsewhere cannot determine foveal) to 12 (unable to determine state of separation). Nonsurgical resolution was defined as a change from baseline score of 5/6/8 to 7/9/10 at Day 90 and Day 180. The assessment of resolution of VMT/sVMA was based upon the anatomical resolution of VMA only, i.e. no resolution of the related symptoms was considered. Thus, the term VMA is used interchangeably with VMT/sVMA. Proportion of subjects is presented as a percentage, with percentage based on the number of subjects who have VMT/sVMA at baseline and SD-OCT value at Day 90/Day 180. One eye (study eye) contributed to the analysis.
Measured: Baseline, Day 90, Day 180
Proportion of Subjects Experiencing Pars Plana Vitrectomy (PPV) at Day 180
Pars plana vitrectomy (the surgical removal of vitreous gel from the eye) was captured in Concomitant Ocular Procedures. Proportion of subjects is reported as a percentage. One eye (study eye) contributed to the analysis.
Measured: Day 180
Mean Nonsurgical Change From Baseline in Central Foveal Thickness (CFT)
Nonsurgical change in central foveal thickness (CFT values after a vitrectomy were imputed with the last non-missing value prior to the vitrectomy) was determined by subtracting the measurements in subretinal fluid and retinal pigment epithelium (RPE) elevations and/or SHRM (subretinal hyper-reflective material, such as choroidal neovascularization (CNV)) from the value in total retinal measurement. A lower CFT indicates improvement. One eye (study eye) contributed to the analysis.
Measured: Baseline (Day 0), Day 28, Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2014 (estimated)
- Study startApr 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Vitreomacular TractionStudies of the same condition, open and under way.
- More trials run by Alcon ResearchThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 628 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sr Clinical Manager, Ophtha-GCRA, Study director, Alcon, a Novartis Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02035748
- Sponsor's protocol ID
- M-13-056
- Other IDs
- 2013-005464-25
- Status last verified
- Aug 2016
- First submitted
- 11 Jan 2014
- Last updated
- 12 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Anatomical and Functional Outcomes in Patients Treated With Ocriplasmin for Vitreomacular Traction/Symptomatic Vitreomacular Adhesion (VMT/sVMA)
- ClinicalTrials.gov ID
- NCT02035748
- Acronym / sponsor ID
- M-13-056
- Conditions
- Vitreomacular Traction, Vitreomacular Adhesion
- Keywords
- Vitreomacular traction, Symptomatic vitreomacular adhesion, Ocriplasmin, JETREA
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 628 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 14 Jan 2014 (estimated)
- Results
- Posted 12 Oct 2016
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 observe the anatomical and functional outcomes of ocriplasmin (JETREA®) over a 6-month follow-up period.
Detailed description
After receiving a single intravitreal injection as per country's product label (Day 0), subjects were followed for a 6-month period (Day 180).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ocriplasmin | Experimental | Drug: OcriplasminOcriplasmin 0.125 mg in a 0.1 mL volume administered as a single dose by intravitreal injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OcriplasminAlso: JETREA®0.5 mg/0.2 mL solution for injection | Drug | Ocriplasmin |
Primary outcome
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: Baseline, Day 28
Vitreous separation was assessed by SD-OCT using scores ranging from 1 (vitreous attached from macula to ON; separated elsewhere cannot determine foveal) to 12 (unable to determine state of separation). Nonsurgical resolution was defined as a change from baseline score of 5/6/8 to 7/9/10 at Day 28. The assessment of resolution of VMT/sVMA was based upon the anatomical resolution of VMA only, i.e. no resolution of the related symptoms was considered. Thus, the term VMA is used interchangeably with VMT/sVMA. Proportion of subjects is presented as a percentage, with percentage based on the number of subjects who have VMT/sVMA at baseline and SD-OCT value at Day 28. One eye (study eye) contributed to the analysis.
5 secondary outcomes
Nonsurgical Change From Baseline in Best-corrected Visual Acuity (BCVA) at Distance
Time frame: Baseline (Day 0), Day 28, Day 90, Day 180
Proportion of Subjects With Nonsurgical Closure of Macular Hole (MH), if Present at Baseline
Time frame: Day 28, Day 90, Day 180
Proportion of Subjects With Nonsurgical Resolution of VMT/sVMA
Time frame: Baseline, Day 90, Day 180
Proportion of Subjects Experiencing Pars Plana Vitrectomy (PPV) at Day 180
Time frame: Day 180
Mean Nonsurgical Change From Baseline in Central Foveal Thickness (CFT)
Time frame: Baseline (Day 0), Day 28, Day 180
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Sr Clinical Manager, Ophtha-GCRA study director
Alcon, a Novartis Company
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ocriplasmin in people with Vitreomacular Traction and Vitreomacular Adhesion, run by Alcon Research.
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 3 inclusion and 20 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 12 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 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: Baseline, Day 28). 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 12 Oct 2016.