Assessment of Patients Treated With JETREA® for Vitreomacular Traction

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Primary Purpose

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Ocriplasmin

About this trial

This is an interventional treatment trial for Vitreomacular Traction focused on measuring Vitreomacular traction, Symptomatic vitreomacular adhesion, Ocriplasmin, JETREA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / 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 injection

Outcomes

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

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.

Secondary Outcome Measures

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT02035748

First Posted

January 11, 2014

Last Updated

August 19, 2016

Sponsor

Alcon Research

1. Study Identification

Unique Protocol Identification Number

NCT02035748

Brief Title

Assessment of Patients Treated With JETREA® for Vitreomacular Traction

Official Title

Assessment of Anatomical and Functional Outcomes in Patients Treated With Ocriplasmin for Vitreomacular Traction/Symptomatic Vitreomacular Adhesion (VMT/sVMA)

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Completed

Study Start Date

April 2014 (undefined)

Primary Completion Date

September 2015 (Actual)

Study Completion Date

September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Alcon Research

4. Oversight

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 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vitreomacular Traction, Vitreomacular Adhesion

Keywords

Vitreomacular traction, Symptomatic vitreomacular adhesion, Ocriplasmin, JETREA

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

628 (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 injection

Intervention Type

Drug

Intervention Name(s)

Ocriplasmin

Other Intervention Name(s)

JETREA®

Intervention Description

0.5 mg/0.2 mL solution for injection

Primary Outcome Measure Information:

Title

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

Description

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.

Time Frame

Baseline, Day 28

Secondary Outcome Measure Information:

Title

Nonsurgical Change From Baseline in Best-corrected Visual Acuity (BCVA) at Distance

Description

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.

Time Frame

Baseline (Day 0), Day 28, Day 90, Day 180

Title

Proportion of Subjects With Nonsurgical Closure of Macular Hole (MH), 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. 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.

Time Frame

Day 28, Day 90, Day 180

Title

Proportion of Subjects With Nonsurgical Resolution of VMT/sVMA

Description

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.

Time Frame

Baseline, Day 90, Day 180

Title

Proportion 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. Proportion of subjects is reported as a percentage. One eye (study eye) contributed to the analysis.

Time Frame

Day 180

Title

Mean Nonsurgical Change From Baseline in Central Foveal Thickness (CFT)

Description

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.

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 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sr Clinical Manager, Ophtha-GCRA

Organizational Affiliation

Alcon, a Novartis Company

Official's Role

Study Director

Vitreomacular Traction, Vitreomacular Adhesion

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial