Vitreomacular TractionPhase 4NCT02322229
Ocriplasmin for Vitreomacular Traction/Symptomatic Vitreomacular Adhesion
A Phase 4 study testing Ocriplasmin 0.125 mg in a 0.1 mL volume in people with Vitreomacular Traction and Vitreomacular Adhesion, run by Alcon Research at 1 site in Australia.
Trial summary
The purpose of this study is to observe the anatomical and functional outcomes of ocriplasmin (JETREA™®) over a 6-month 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 0.125 mg in a 0.1 mL volume
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteAustralia
- Study dates
- 26 May 2015to 9 May 2016
- 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 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.
- Willing and able to attend all study visits.
- Other protocol-specified inclusion criteria may apply.
Who cannot join
- Women of childbearing potential if pregnant, test positive on a urine pregnancy test, intend to become pregnant during the study period, 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 in either eye.
- Participation in any interventional clinical trial within 30 days prior to baseline.
- Presence of epiretinal membrane (ERM) over the macula at baseline in the study eye.
- Broad VMT/VMA > 1500 microns at baseline in the study eye.
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- History of vitrectomy in the study eye.
- History of laser photocoagulation to the macula in the study eye.
- Any relevant concomitant ocular condition in the study eye that, in the opinion of the Investigator, could be expected to worsen or require surgical intervention during the study period.
- Macular hole of > 400 microns diameter in the study eye.
- High myopia in the study eye.
- Pseudo-exfoliation, Marfan's syndrome, phacodonesis, or any other finding in the study eye that, in the Investigator's opinion, suggests lens/zonular instability.
- Aphakia in the study eye.
- History of retinal detachment in the study eye.
- Recent ocular surgery or ocular injection in the study eye within the past 90 days (including laser therapy).
- Proliferative diabetic retinopathy or ischemic retinopathies in the study eye.
- Retinal vein occlusions in the study eye.
- Exudative age-related macular degeneration (AMD) in the study eye.
- Vitreous hemorrhage in the study eye.
- Other protocol-specified exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
Australia1 site
Contact Alcon Laboratories (Australia) for Trial Locations
New South Wales, 2113
About this study
Official title: Assessment of Anatomical and Functional Outcomes in Subjects 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 period.
- Conditions
- Vitreomacular Traction, Vitreomacular Adhesion
- Being tested
- Ocriplasmin 0.125 mg in a 0.1 mL volume
- Keywords
- VMT, sVMA, vitrectomy, ocriplasmin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ocriplasmin 0.125 mg in a 0.1 mL volumeDrug
Also called JETREA™®
| 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 (IVT) injection Receives: Drug: Ocriplasmin 0.125 mg in a 0.1 mL volume |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects With Non-surgical Resolution of Focal VMT/sVMA 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 according to CRC OCT image reading, into 1 of 12 categories, where the targeted status of VMA resolution was 7=Vitreous attached only at optic nerve (ON) or at ON and elsewhere, but not attached in macular, 9=Vitreous visible with complete separation and no attachment, and 10=No visible vitreous separation, which needed to be reached without prior vitrectomy. 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. One eye (study eye) contributed to the analysis.
Measured: Day 28
Secondary outcomes (5)
Change From Baseline in Best-corrected Visual Acuity (BCVA) at Distance at Days 7, 28, 90, and 180
BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) testing. BCVA was determined as follows: if tested at 4 meters, BCVA=the number of letters read correctly at 4 meters+30; if tested at 1 meter, BCVA=the number of letters read correctly at 1 meter, with 83-84 representing normal vision. BCVA change was defined as a change in letters read from the baseline assessment. A positive change value indicates improvement. One eye (study eye) contributed to the analysis.
Measured: Baseline (Day 0), Day 7, Day 28, Day 90, Day 180
Percentage of Subjects With Closure of Macular Hole (MH), at Days 7, 28, 90, and 180 (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. One eye (study eye) contributed to the analysis.
Measured: Day 7, Day 28, Day 90, Day 180
Percentage of Subjects With Non-surgical Resolution of VMT/sVMA at Days 7, 90, and 180
As described in Primary Outcome Measure
Measured: Baseline (Day 0), Day 7, Day 90, Day 180
Percentage 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. One eye (study eye) contributed to the analysis.
Measured: Day 180
Change From Baseline in Central Foveal Thickness at Days 28 and 180
Central foveal thickness (CFT) was determined by subtracting the measurements in subretinal fluid (SRF) and retinal pigment epithelium (RPE) elevation and/or subretinal hyper-reflective material (SHRM) from the value in total retinal measurement. The change was defined as a change from baseline values of CFT. 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 posted23 Dec 2014 (estimated)
- Study start26 May 2015
- Primary completion11 Dec 2015
- Study completion9 May 2016
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
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Associate Dir of Operations, Ophthalmology, GMA, Study director, Alcon, A Novartis Division
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02322229
- Sponsor's protocol ID
- RTA255-P001
- Status last verified
- Oct 2017
- First submitted
- 17 Dec 2014
- Last updated
- 21 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Anatomical and Functional Outcomes in Subjects Treated With Ocriplasmin for Vitreomacular Traction/Symptomatic Vitreomacular Adhesion (VMT/sVMA)
- ClinicalTrials.gov ID
- NCT02322229
- Acronym / sponsor ID
- RTA255-P001
- Conditions
- Vitreomacular Traction, Vitreomacular Adhesion
- Keywords
- VMT, sVMA, vitrectomy, ocriplasmin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 26 May 2015 (actual)
- Primary completion
- 11 Dec 2015 (actual)
- Study completion
- 9 May 2016 (actual)
- First posted
- 23 Dec 2014 (estimated)
- Results
- Posted 23 Jul 2018
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 period.
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: Ocriplasmin 0.125 mg in a 0.1 mL volumeOcriplasmin 0.125 mg in a 0.1 mL volume administered as a single dose by intravitreal (IVT) injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of 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.
- Willing and able to attend all study visits.
- Other protocol-specified inclusion criteria may apply.
Key exclusion criteria (20 listed)
- Women of childbearing potential if pregnant, test positive on a urine pregnancy test, intend to become pregnant during the study period, 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 in either eye.
- Participation in any interventional clinical trial within 30 days prior to baseline.
- Presence of epiretinal membrane (ERM) over the macula at baseline in the study eye.
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 |
|---|---|---|
| Ocriplasmin 0.125 mg in a 0.1 mL volumeAlso: JETREA™® | Drug | Ocriplasmin |
Primary outcome
Percentage of Subjects With Non-surgical Resolution of Focal VMT/sVMA at Day 28, as Determined by Central Reading Center (CRC) Spectral Domain Optical Coherence Tomography (SD-OCT) Evaluation
Time frame: Day 28
Vitreous separation was assessed, by SD-OCT according to CRC OCT image reading, into 1 of 12 categories, where the targeted status of VMA resolution was 7=Vitreous attached only at optic nerve (ON) or at ON and elsewhere, but not attached in macular, 9=Vitreous visible with complete separation and no attachment, and 10=No visible vitreous separation, which needed to be reached without prior vitrectomy. 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. One eye (study eye) contributed to the analysis.
5 secondary outcomes
Change From Baseline in Best-corrected Visual Acuity (BCVA) at Distance at Days 7, 28, 90, and 180
Time frame: Baseline (Day 0), Day 7, Day 28, Day 90, Day 180
Percentage of Subjects With Closure of Macular Hole (MH), at Days 7, 28, 90, and 180 (if Present at Baseline)
Time frame: Day 7, Day 28, Day 90, Day 180
Percentage of Subjects With Non-surgical Resolution of VMT/sVMA at Days 7, 90, and 180
Time frame: Baseline (Day 0), Day 7, Day 90, Day 180
Percentage of Subjects Experiencing Pars Plana Vitrectomy (PPV) at Day 180
Time frame: Day 180
Change From Baseline in Central Foveal Thickness at Days 28 and 180
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 21 Aug 2018.
- 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.
Associate Dir of Operations, Ophthalmology, GMA study director
Alcon, A Novartis Division
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ocriplasmin 0.125 mg in a 0.1 mL volume in people with Vitreomacular Traction and Vitreomacular Adhesion, run by Alcon Research at 1 site in Australia.
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 4 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 21 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. 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.
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 23 Jul 2018). 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?
Percentage of Subjects With Non-surgical Resolution of Focal VMT/sVMA at Day 28, as Determined by Central Reading Center (CRC) Spectral Domain Optical Coherence Tomography (SD-OCT) Evaluation (time frame: 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 21 Aug 2018.