Vitrectomy
Conditions
Brief summary
A multicenter study to compare multiple doses of intravitreal microplasmin in patients undergoing surgical vitrectomy.
Interventions
DRUGOcriplasmin 25µg
Intravitreal injection of 0.1 ml of ocriplasmin solution containing 25µg of ocriplasmin.
DRUGOcriplasmin 75µg
Intravitreal injection of 0.1 ml of ocriplasmin solution containing 75µg of ocriplasmin.
Intravitreal injection of 0.1 ml of ocriplasmin solution containing 125µg of ocriplasmin.
DRUGPlacebo
Intravitreal injection of 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
* Patients in whom vitrectomy is indicated
Exclusion criteria
* Posterior Vitreous Detachment (PVD) present at baseline * Vitreous hemorrhage * Certain vitreoretinal conditions including proliferative disease, rhegmatogenous retinal detachment, and proliferative vitreoretinopathy (PVR) * Have had a vitrectomy in the study eye at any time
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients Achieving Total Posterior Vitreous Detachment (PVD) Without Creation of an Anatomical Defect | Day 7 | The primary efficacy endpoint was the proportion of patients achieving total PVD without creation of an anatomical defect (ie, retinal hole, retinal detachment) based on surgeon visualization at the beginning of vitrectomy prior to suction or any other mechanical intervention. |
Countries
United States
Participant flow
Recruitment details
The first patient was recruited on 29 Mar 2007 and the last patient completed the study on 02 Oct 2008.
Participants by arm
| Arm | Count |
|---|---|
| Ocriplasmin 25µg 25µg ocriplasmin intravitreal injection | 29 |
| Ocriplasmin 75µg 75µg ocriplasmin intravitreal injection. | 33 |
| Ocriplasmin 125µg 125µg ocriplasmin intravitreal injection. | 32 |
| Placebo Intravitreal injection of placebo. | 31 |
| Total | 125 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 0 | 0 |
| Overall Study | Death | 0 | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 | 0 | 0 |
| Overall Study | Transport issue | 0 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Ocriplasmin 25µg | Ocriplasmin 75µg | Ocriplasmin 125µg | Placebo | Total |
|---|---|---|---|---|---|
| Age, Continuous | 66.9 years STANDARD_DEVIATION 8.28 | 68.8 years STANDARD_DEVIATION 9.07 | 66.9 years STANDARD_DEVIATION 11.4 | 65.7 years STANDARD_DEVIATION 11.6 | 66.1 years STANDARD_DEVIATION 10.16 |
| Sex: Female, Male Female | 20 Participants | 23 Participants | 20 Participants | 22 Participants | 85 Participants |
| Sex: Female, Male Male | 9 Participants | 10 Participants | 12 Participants | 9 Participants | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 29 / 29 | 32 / 33 | 31 / 32 | 30 / 31 |
| serious Total, serious adverse events | 2 / 29 | 3 / 33 | 0 / 32 | 2 / 31 |
Outcome results
Primary
Proportion of Patients Achieving Total Posterior Vitreous Detachment (PVD) Without Creation of an Anatomical Defect
The primary efficacy endpoint was the proportion of patients achieving total PVD without creation of an anatomical defect (ie, retinal hole, retinal detachment) based on surgeon visualization at the beginning of vitrectomy prior to suction or any other mechanical intervention.
Time frame: Day 7
Population: Intent-To-Treat (ITT). Full Analysis Set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ocriplasmin 25µg | Proportion of Patients Achieving Total Posterior Vitreous Detachment (PVD) Without Creation of an Anatomical Defect | 13.8 percentage of participants |
| Ocriplasmin 75µg | Proportion of Patients Achieving Total Posterior Vitreous Detachment (PVD) Without Creation of an Anatomical Defect | 18.2 percentage of participants |
| Ocriplasmin 125µg | Proportion of Patients Achieving Total Posterior Vitreous Detachment (PVD) Without Creation of an Anatomical Defect | 31.3 percentage of participants |
| Placebo | Proportion of Patients Achieving Total Posterior Vitreous Detachment (PVD) Without Creation of an Anatomical Defect | 10 percentage of participants |
Comparison: P-values are from Wald chi-square tests from a logistic regression model with study center and treatment as categorical fixed effects comparing active treatment groups with the placebo group as the reference group.p-value: 0.79695% CI: [0.24, 6.36]Regression, Logistic
Comparison: P-values are from Wald chi-square test from a logistic regression model with study center and treatment as categorical fixed effects comparing active treatment groups with the placebo group as the reference group.p-value: 0.44795% CI: [0.39, 8.36]Regression, Logistic
Comparison: P-values are from Wald chi-square test from a logistic regression model with study center and treatment as categorical fixed effects comparing active treatment groups with the placebo group as the reference group.p-value: 0.10795% CI: [0.77, 13.95]Regression, Logistic