Vitrectomy
Conditions
Keywords
Safety in pediatrics
Brief summary
To evaluate the safety and preliminary efficacy of intravitreal microplasmin as an adjunct to conventional vitrectomy for the treatment of pediatric patients.
Interventions
DRUGOcriplasmin
175µg ocriplasmin intravitreal injection
DRUGPlacebo
Placebo intravitreal injection
Sponsors
ThromboGenics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
No minimum to 16 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female infants or children 16 years of age or younger 2. Patient must be a suitable candidate for conventional 2-port or 3-port pars plana vitrectomy 3. Patient with attached vitreous somewhere in posterior pole 4. Patient's parent or guardian must be willing and able to comply with follow-up requirements 5. Patient's parent(s) must sign informed parental permission form and in the case of school-age children the patient must sign assent form
Exclusion criteria
1. Patient diagnosed with Stage 1, 2, 3 or 5 retinopathy of prematurity (ROP) at the time of surgery 2. Unclear media, which precludes assessment of the posterior pole such as a cataract or vitreal opacity 3. Active parental/guardian drug or alcohol use or dependence that, in the opinion of the site Investigator, would interfere with parent's or guardian's adherence to study requirements 4. Medical problems that make consistent follow-up over the treatment period uncertain. 5. Patient must not have participated in an investigational drug or device study in the prior 30 days 6. Female Patients of childbearing potential must not be pregnant or lactating.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Eyes With Total Macular Posterior Vitreous Detachment (PVD). | Beginning of vitrectomy or after application of suction | Percentage of eyes with total macular PVD (to the vascular ridge in eyes with ROP) at the beginning of vitrectomy or after application of suction, as assessed by masked surgeon observation under the operating microscope. |
Countries
United States
Participant flow
Recruitment details
First subject was recruited on 10 Feb 2010 and last subject completed the study on 14 Dec 2011. 24 study eyes (16 ocriplasmin, 8 placebo) were evaluated during the study. 22 subjects were enrolled in the study. 2 subjects were treated in both eyes.
Participants by arm
| Arm | Count |
|---|---|
| Ocriplasmin Ocriplasmin : 175µg ocriplasmin intravitreal injection | 16 |
| Placebo Placebo : Placebo intravitreal injection | 8 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 2 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | Ocriplasmin | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 6.1 years STANDARD_DEVIATION 6.4 | 8.0 years STANDARD_DEVIATION 6.61 | 6.8 years STANDARD_DEVIATION 6.39 |
| Sex: Female, Male Female | 3 Participants | 1 Participants | 4 Participants |
| Sex: Female, Male Male | 13 Participants | 7 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 15 / 16 | 8 / 8 |
| serious Total, serious adverse events | 2 / 16 | 2 / 8 |
Outcome results
Primary
Percentage of Eyes With Total Macular Posterior Vitreous Detachment (PVD).
Percentage of eyes with total macular PVD (to the vascular ridge in eyes with ROP) at the beginning of vitrectomy or after application of suction, as assessed by masked surgeon observation under the operating microscope.
Time frame: Beginning of vitrectomy or after application of suction
Population: Study eyes were analysed according to the Intent-to-Treat (ITT) principle, i.e. as randomised regardless of treatment received. The primary endpoint was evaluated using the Full Analysis Set (FAS), with missing data imputed using the Last Observation Carried Forward (LOCF) method. 1 subject contributed 1 eye to both treatment groups
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ocriplasmin | Percentage of Eyes With Total Macular Posterior Vitreous Detachment (PVD). | 50 percentage of eyes |
| Placebo | Percentage of Eyes With Total Macular Posterior Vitreous Detachment (PVD). | 62.5 percentage of eyes |
p-value: 0.67995% CI: [0.07, 4.509]Fisher Exact