Back to resultsOcriplasmin for Vitreomacular Traction/Symptomatic Vitreomacular Adhesion
Primary Purpose
Vitreomacular Traction, Vitreomacular Adhesion
Status
Completed
Phase
Phase 4
Locations
Australia
Study Type
Interventional
Intervention
Ocriplasmin 0.125 mg in a 0.1 mL volume
Sponsored by
About this trial
This is an interventional treatment trial for Vitreomacular Traction focused on measuring VMT, sVMA, vitrectomy, ocriplasmin
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Sites / Locations
- Contact Alcon Laboratories (Australia) for Trial Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ocriplasmin
Arm Description
Ocriplasmin 0.125 mg in a 0.1 mL volume administered as a single dose by intravitreal (IVT) injection
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Percentage of Subjects With Non-surgical Resolution of VMT/sVMA at Days 7, 90, and 180
As described in Primary Outcome Measure
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02322229
Brief Title
Ocriplasmin for Vitreomacular Traction/Symptomatic Vitreomacular Adhesion
Official Title
Assessment of Anatomical and Functional Outcomes in Subjects Treated With Ocriplasmin for Vitreomacular Traction/Symptomatic Vitreomacular Adhesion (VMT/sVMA)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
May 26, 2015 (Actual)
Primary Completion Date
December 11, 2015 (Actual)
Study Completion Date
May 9, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to observe the anatomical and functional outcomes of ocriplasmin (JETREA™®) over a 6-month period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitreomacular Traction, Vitreomacular Adhesion
Keywords
VMT, sVMA, vitrectomy, ocriplasmin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ocriplasmin
Arm Type
Experimental
Arm Description
Ocriplasmin 0.125 mg in a 0.1 mL volume administered as a single dose by intravitreal (IVT) injection
Intervention Type
Drug
Intervention Name(s)
Ocriplasmin 0.125 mg in a 0.1 mL volume
Other Intervention Name(s)
JETREA™®
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Day 28
Secondary Outcome Measure Information:
Title
Change From Baseline in Best-corrected Visual Acuity (BCVA) at Distance at Days 7, 28, 90, and 180
Description
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.
Time Frame
Baseline (Day 0), Day 7, Day 28, Day 90, Day 180
Title
Percentage of Subjects With Closure of Macular Hole (MH), at Days 7, 28, 90, and 180 (if Present at Baseline)
Description
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.
Time Frame
Day 7, Day 28, Day 90, Day 180
Title
Percentage of Subjects With Non-surgical Resolution of VMT/sVMA at Days 7, 90, and 180
Description
As described in Primary Outcome Measure
Time Frame
Baseline (Day 0), Day 7, Day 90, Day 180
Title
Percentage of Subjects Experiencing Pars Plana Vitrectomy (PPV) at Day 180
Description
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.
Time Frame
Day 180
Title
Change From Baseline in Central Foveal Thickness at Days 28 and 180
Description
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.
Time Frame
Baseline (Day 0), Day 28, Day 180
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Associate Dir of Operations, Ophthalmology, GMA
Organizational Affiliation
Alcon, A Novartis Division
Official's Role
Study Director
Facility Information:
Facility Name
Contact Alcon Laboratories (Australia) for Trial Locations
City
New South Wales
ZIP/Postal Code
2113
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
Ocriplasmin for Vitreomacular Traction/Symptomatic Vitreomacular Adhesion
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