Assessment of Patients Treated With JETREA® for Vitreomacular Traction

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

Population: This analysis population includes all subjects who received treatment with IP and had at least one post-treatment measurement of SD-OCT (FAS). Missing data imputed using the last observation carried forward (LOCF) method. Subjects who had vitrectomy after VMT/sVMA resolution were considered as 'no resolution' after timepoint of vitrectomy.

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

Population: Full Analysis Set. Missing data is imputed using LOCF. CFT values after a vitrectomy were imputed with the last non-missing value prior to the vitrectomy.

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

Population: Full Analysis Set. Missing data imputed using LOCF. BCVA values after a vitrectomy were imputed with the last non-missing value prior to the vitrectomy.

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

Population: Full Analysis Set

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

Population: Full Analysis Set. Missing data imputed using LOCF. Subjects who had vitrectomy after MH closure were considered as 'no MH closure' after the timepoint of vitrectomy.

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

Population: Full Analysis Set. Missing data imputed using LOCF. Subjects who had vitrectomy after VMT/sVMA resolution were considered as 'no resolution' after the timepoint of vitrectomy.