Vitreomacular Adhesion
Conditions
Brief summary
This trial will evaluate the safety and efficacy of microplasmin, administered as an intravitreal injection, in subjects with focal vitreomacular adhesion. In previously performed clinical trials, some patients treated with intravitreal microplasmin have had resolution of their underlying condition, including macular hole closure, without need for vitrectomy. This clinical trial is justified because the sponsor believes the potential benefits outweigh the potential risks.
Interventions
125µg of ocriplasmin intravitreal injection
DRUGPlacebo
Intravitreal injection placebo.
Sponsors
ThromboGenics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Presence of focal vitreomacular adhesion (i.e., central vitreal adhesion within 6 mm Optical Coherence Tomography (OCT) field surrounded by elevation of the posterior vitreous cortex) that in the opinion of the Investigator is related to decreased visual function (such as metamorphopsia, decreased visual acuity, or other visual complaint)
Exclusion criteria
* Any evidence of proliferative retinopathy (including Proliferative Diabetic Retinopathy (PDR)) or other ischemic retinopathies involving vitreoretinal vascular proliferation) or exudative Age-Related Macular Degeneration (AMD) or retinal vein occlusion in the study eye * Subjects with any vitreous hemorrhage or any other vitreous opacification which precludes either of the following: visualization of the posterior pole by visual inspection OR adequate assessment of the macula by either OCT and/or fluorescein angiogram in the study eye * Subjects with macular hole diameter \> 400 µm in the study eye * Aphakia in the study eye * High myopia (more than 8D) in study eye (unless prior cataract extraction or refractive surgery that makes refraction assessment unreliable for myopia severity approximation, in which case axial length \>28 mm is an exclusion).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subjects With Nonsurgical Resolution of Focal Vitreomacular Adhesion at Day 28 | Day 28 | Proportion of subjects with nonsurgical resolution of focal vitreomacular adhesion at Day 28, as determined by masked Central Reading Centre (CRC) Optical Coherence Tomography(OCT)evaluation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subjects With Total Posterior Vitreous Detachment (PVD) at Day 28 | Day 28 | Proportion of subjects with total PVD at Day 28, as determined by masked investigator assessment of B-scan ultrasound. |
Countries
Belgium, Czechia, Germany, Poland, Spain, United Kingdom, United States
Participant flow
Recruitment details
First patient was recruited on 23 Dec 2008 and last patient completed the study on 15 Jun 2010
Participants by arm
| Arm | Count |
|---|---|
| Ocriplasmin 125µg 125µg ocriplasmin intravitreal injection. | 245 |
| Placebo Intravitreal injection of placebo | 81 |
| Total | 326 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 |
| Overall Study | Death | 1 | 0 |
| Overall Study | Lost to Follow-up | 2 | 2 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Withdrawal by Subject | 5 | 4 |
Baseline characteristics
| Characteristic | Ocriplasmin 125µg | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 72.6 years STANDARD_DEVIATION 7.56 | 70.2 years STANDARD_DEVIATION 10.85 | 72.0 years STANDARD_DEVIATION 8.54 |
| Sex: Female, Male Female | 166 Participants | 56 Participants | 222 Participants |
| Sex: Female, Male Male | 79 Participants | 25 Participants | 104 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 105 / 245 | 22 / 81 |
| serious Total, serious adverse events | 33 / 245 | 11 / 81 |
Outcome results
Primary
Proportion of Subjects With Nonsurgical Resolution of Focal Vitreomacular Adhesion at Day 28
Proportion of subjects with nonsurgical resolution of focal vitreomacular adhesion at Day 28, as determined by masked Central Reading Centre (CRC) Optical Coherence Tomography(OCT)evaluation.
Time frame: Day 28
Population: Intention-To-Treat (ITT), Last Observation Carried Forward LOCF)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ocriplasmin 125µg | Proportion of Subjects With Nonsurgical Resolution of Focal Vitreomacular Adhesion at Day 28 | 25.3 percentage of participants |
| Placebo | Proportion of Subjects With Nonsurgical Resolution of Focal Vitreomacular Adhesion at Day 28 | 6.2 percentage of participants |
p-value: <0.00195% CI: [1.97, 17]Fisher Exact
Secondary
Proportion of Subjects With Total Posterior Vitreous Detachment (PVD) at Day 28
Proportion of subjects with total PVD at Day 28, as determined by masked investigator assessment of B-scan ultrasound.
Time frame: Day 28
Population: Intention-To-Treat (ITT), Last Observation Carried Forward LOCF)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ocriplasmin 125µg | Proportion of Subjects With Total Posterior Vitreous Detachment (PVD) at Day 28 | 10.6 percentage of participants |
| Placebo | Proportion of Subjects With Total Posterior Vitreous Detachment (PVD) at Day 28 | 0 percentage of participants |