Symptomatic Vitreomacular Adhesion
Conditions
Keywords
Vitreomacular Adhesion, Vitreomacular Traction, Vitreomacular Traction Syndrome, Vitrectomy, Central Visual Field Defect, Blind Spot, Intravitreal Injection, Macula, Retina, Decreased Visual Acuity, Visual Complaint, SD-OCT, Macular Hole
Brief summary
The purpose of this study is to evaluate the superiority regarding vitreomacular adhesion (VMA) resolution of a single intravitreal injection of A01016 (Ocriplasmin) compared to sham-injection in subjects with symptomatic VMA.
Interventions
DRUGOcriplasmin
DRUGSham injection
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Symptomatic vitreomacular adhesion (VMA) which, in the opinion of the Investigator, is related to decreased visual function; * Best corrected visual acuity (BCVA) of 20/25 or worse in the study eye; * BCVA of 20/800 or better in the non-study eye; * Provide written informed consent; * Follow specified instructions during study period; * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Evidence of proliferative retinopathy, exudative age-related macular degeneration, or retinal vein occlusion in the study eye; * Vitreous hemorrhage or other opacification; * High myopia in the study eye; * Ocular surgery, laser photocoagulation treatment, or intravitreal injection(s) in the study eye in the prior 3 months; * Uncontrolled glaucoma in the study eye; * History of retinal detachment in either eye; * Active infection in either eye; * Pregnant or of child-bearing potential and not utilizing acceptable form of contraception; * Participation in another investigational drug study within 30 days prior to this study; * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subjects With Non-Surgical Resolution of Vitreomacular Adhesion (VMA) | Day 28 | VMA (adhesion of the vitreous gel to the retina in an abnormally strong manner) was determined by masked Central Reading Center (CRC) Spectral Domain Optical Coherence Tomography (SD-OCT) evaluation. Only one eye (study eye) was analyzed. Proportion of subjects is reported as a percentage. |
Countries
Japan
Participant flow
Recruitment details
Subjects were recruited from 40 study centers located in Japan.
Pre-assignment details
Of the 251 enrolled, 79 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (172).
Participants by arm
| Arm | Count |
|---|---|
| Ocriplasmin Single intravitreal injection to the study eye at baseline | 115 |
| Sham Injection Single sham injection to the study eye at baseline | 57 |
| Total | 172 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
Baseline characteristics
| Characteristic | Ocriplasmin | Sham Injection | Total |
|---|---|---|---|
| Age, Continuous | 68.1 years STANDARD_DEVIATION 7.3 | 68.6 years STANDARD_DEVIATION 9.2 | 68.2 years STANDARD_DEVIATION 8 |
| Sex: Female, Male Female | 59 Participants | 32 Participants | 91 Participants |
| Sex: Female, Male Male | 56 Participants | 25 Participants | 81 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 63 / 114 | 19 / 58 |
| serious Total, serious adverse events | 23 / 114 | 4 / 58 |
Outcome results
Primary
Proportion of Subjects With Non-Surgical Resolution of Vitreomacular Adhesion (VMA)
VMA (adhesion of the vitreous gel to the retina in an abnormally strong manner) was determined by masked Central Reading Center (CRC) Spectral Domain Optical Coherence Tomography (SD-OCT) evaluation. Only one eye (study eye) was analyzed. Proportion of subjects is reported as a percentage.
Time frame: Day 28
Population: This analysis population includes all subjects who received study medication, completed at least 1 on-therapy study visit and had symptomatic VMA at baseline, as randomized, based on an intent to treat approach.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ocriplasmin | Proportion of Subjects With Non-Surgical Resolution of Vitreomacular Adhesion (VMA) | 52.2 percentage of subjects |
| Sham Injection | Proportion of Subjects With Non-Surgical Resolution of Vitreomacular Adhesion (VMA) | 1.8 percentage of subjects |