Vitreomacular Traction
Conditions
Keywords
Vitreomacular Traction, Maculopathy, VMT, PVD
Brief summary
A multicenter study to compare multiple doses of intravitreal microplasmin for non-surgical PVD induction for treatment of patients with vitreomacular traction.
Interventions
DRUGocriplasmin
Intravitreal injection of ocriplasmin solution containing 75µg of ocriplasmin.
DRUGSham Comparator
Intravitreal sham injection
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
* Patients \>\_ 18 years of age with vitreomacular traction
Exclusion criteria
* PVD present at baseline * Certain vitreoretinal conditions including proliferative disease, rhegmatogenous retinal detachment, and proliferative vitreoretinopathy (PVR) * Vitreous hemorrhage * Patients who have had a vitrectomy in the study eye at any time
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of Subjects With Total PVD at the First Day 14 Post-injection Visit (Vitreous Detachment to the Equator) as Determined by Masked Central Reading Center (CRC) Evaluation of B-scan Imaging. | Day 14 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Resolution of Vitreomacular Traction (Investigator's Assessment) | Day 28 | Resolution of VMT was evaluated by the investigator using optical coherence tomography (OCT).Resolution of VMT was defined as a change from baseline status of Yes to post-injection status of No and was evaluated by the investigator using OCT. Subjects undergoing vitrectomy had their last observation prior to vitrectomy carried forward. |
Countries
Belgium, Germany
Participant flow
Recruitment details
The first patient was enrolled on 2 March 2007 and the last patient completed the last visit on 8 January 2009. All patients were selected in medical clinics
Pre-assignment details
All subjects in all cohorts had a similar follow-up schedule to the day 28 post-injection visit. After day 28, non-responders in cohort 4 received up to 2 repeated injections and thus had a different study follow-up schedule than all other subjects.
Participants by arm
| Arm | Count |
|---|---|
| Ocriplasmin 75µg Single Injection ocriplasmin 75µg single injection versus sham injection | 12 |
| Ocriplasmin 125µg Single Injection ocriplasmin 125µg single injection versus sham injection | 13 |
| Ocriplasmin 175µg Single Injection ocriplasmin 175µg single injection versus sham injection | 11 |
| Ocriplasmin 125µg Multiple Injections ocriplasmin 125µg multiple injections Subjects who did not achieve resolution of VMT by the day 28 visit (i.e. non-responders) were given an open-label injection of ocriplasmin 125 μg. Subjects who still did not achieve resolution of VMT by the day 56 visit were given a second open-label injection of ocriplasmin 125 μg. | 12 |
| Sham Injection sham injection | 12 |
| Total | 60 |
Baseline characteristics
| Characteristic | Ocriplasmin 75µg Single Injection | Ocriplasmin 125µg Single Injection | Ocriplasmin 175µg Single Injection | Ocriplasmin 125µg Multiple Injections | Sham Injection | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 66.58 years STANDARD_DEVIATION 5.57 | 74.67 years STANDARD_DEVIATION 5.78 | 66.11 years STANDARD_DEVIATION 9.08 | 70.61 years STANDARD_DEVIATION 6.67 | 70.28 years STANDARD_DEVIATION 8.58 | 69.79 years STANDARD_DEVIATION 7.66 |
| Sex: Female, Male Female | 8 Participants | 8 Participants | 4 Participants | 7 Participants | 6 Participants | 33 Participants |
| Sex: Female, Male Male | 4 Participants | 5 Participants | 7 Participants | 5 Participants | 6 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 10 / 12 | 10 / 13 | 10 / 11 | 11 / 12 | 9 / 12 |
| serious Total, serious adverse events | 3 / 12 | 2 / 13 | 3 / 11 | 4 / 12 | 0 / 12 |
Outcome results
Primary
Proportion of Subjects With Total PVD at the First Day 14 Post-injection Visit (Vitreous Detachment to the Equator) as Determined by Masked Central Reading Center (CRC) Evaluation of B-scan Imaging.
Time frame: Day 14
Population: Intention to Treat (ITT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ocriplasmin 75µg Single Injection | Proportion of Subjects With Total PVD at the First Day 14 Post-injection Visit (Vitreous Detachment to the Equator) as Determined by Masked Central Reading Center (CRC) Evaluation of B-scan Imaging. | 18.2 percentage of participants |
| Ocriplasmin 175µg Single Injection | Proportion of Subjects With Total PVD at the First Day 14 Post-injection Visit (Vitreous Detachment to the Equator) as Determined by Masked Central Reading Center (CRC) Evaluation of B-scan Imaging. | 18.2 percentage of participants |
| Ocriplasmin 125µg Pooled | Proportion of Subjects With Total PVD at the First Day 14 Post-injection Visit (Vitreous Detachment to the Equator) as Determined by Masked Central Reading Center (CRC) Evaluation of B-scan Imaging. | 13.6 percentage of participants |
| Sham Injection | Proportion of Subjects With Total PVD at the First Day 14 Post-injection Visit (Vitreous Detachment to the Equator) as Determined by Masked Central Reading Center (CRC) Evaluation of B-scan Imaging. | 0 percentage of participants |
p-value: 0.4762Fisher Exact
p-value: 0.4762Fisher Exact
p-value: 0.5343Fisher Exact
Secondary
Resolution of Vitreomacular Traction (Investigator's Assessment)
Resolution of VMT was evaluated by the investigator using optical coherence tomography (OCT).Resolution of VMT was defined as a change from baseline status of Yes to post-injection status of No and was evaluated by the investigator using OCT. Subjects undergoing vitrectomy had their last observation prior to vitrectomy carried forward.
Time frame: Day 28
Population: Intention to Treat (ITT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ocriplasmin 75µg Single Injection | Resolution of Vitreomacular Traction (Investigator's Assessment) | 25 Percentage of participants |
| Ocriplasmin 175µg Single Injection | Resolution of Vitreomacular Traction (Investigator's Assessment) | 27.3 Percentage of participants |
| Ocriplasmin 125µg Pooled | Resolution of Vitreomacular Traction (Investigator's Assessment) | 11 Percentage of participants |
| Sham Injection | Resolution of Vitreomacular Traction (Investigator's Assessment) | 8.3 Percentage of participants |
p-value: 0.4783Fisher Exact
p-value: 0.0932Fisher Exact
p-value: 0.0721Fisher Exact