Diabetic Macular Edema
Conditions
Keywords
Diabetic Macular Edema, PVD, DME, Diabetic Retinopathy
Brief summary
A multicenter study to compare multiple doses of intravitreal microplasmin for non-surgical PVD induction for treatment of patients with DME.
Interventions
DRUGocriplasmin
Intravitreal injection, single administration
OTHERSham injection
Sham intravitreal injection
Sponsors
ThromboGenics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
include: * patients \>18 years of age with Diabetic Macular Edema
Exclusion criteria
include: * PVD present at baseline * Vitreous hemorrhage * Certain vitreoretinal conditions including proliferative disease, rhegmatogenous retinal detachment, and proliferative vitreoretinopathy (PVR) * Patients who have had a vitrectomy in the study eye at any time
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PVD Induction | Day 14 post-injection | The primary efficacy variable was the proportion of patients with total posterior vitreous detachment (PVD) on Day 14 as determined by a masked central reading center (CRC) using 4-quadrant B-scan and optical coherence tomography (OCT) |
Countries
Belgium, Germany, Italy, Netherlands, Spain, United Kingdom
Participant flow
Recruitment details
The first patient was enrolled on 15 December 2006 and the last patient completed the last visit on 19 January 2010. All patients were selected in medical clinics
Pre-assignment details
The trial investigated 3 doses: 25, 75 and 125µg in 3 consecutive cohorts. Patients in each cohort were to be randomized to active treatment or sham injection in a 3:1 ratio. Enrolment into the high dose microplasmin groups was to start only after acceptable safety had been achieved with the previous doses as determined by a Study Safety Committee.
Participants by arm
| Arm | Count |
|---|---|
| Ocriplasmin 25µg 25µg ocriplasmin intravitreal injection versus sham injection | 8 |
| Ocriplasmin 75µg 75µg ocriplasmin intravitreal injection versus sham injection | 15 |
| Ocriplasmin 125µg 125µg ocriplasmin intravitreal injection versus sham injection | 15 |
| Sham Injection Sham injection
Sham injection : Sham intravitreal injection | 13 |
| Total | 51 |
Baseline characteristics
| Characteristic | Ocriplasmin 25µg | Ocriplasmin 75µg | Ocriplasmin 125µg | Sham Injection | Total |
|---|---|---|---|---|---|
| Age, Continuous | 61.6 years STANDARD_DEVIATION 9.8 | 67.3 years STANDARD_DEVIATION 8.8 | 61.7 years STANDARD_DEVIATION 13.4 | 69.9 years STANDARD_DEVIATION 6.2 | 63.9 years STANDARD_DEVIATION 11.1 |
| Sex: Female, Male Female | 5 Participants | 6 Participants | 4 Participants | 4 Participants | 19 Participants |
| Sex: Female, Male Male | 3 Participants | 9 Participants | 11 Participants | 9 Participants | 32 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 | 1 / 8 | 4 / 15 | 5 / 15 | 7 / 13 |
| serious Total, serious adverse events | 1 / 8 | 4 / 15 | 5 / 15 | 9 / 13 |
Outcome results
Primary
PVD Induction
The primary efficacy variable was the proportion of patients with total posterior vitreous detachment (PVD) on Day 14 as determined by a masked central reading center (CRC) using 4-quadrant B-scan and optical coherence tomography (OCT)
Time frame: Day 14 post-injection
Population: Intent-To-Treat (ITT), Last Observation Carried Forward (LOCF)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ocriplasmin 25µg | PVD Induction | 0 percentage of participants |
| Ocriplasmin 75µg | PVD Induction | 20 percentage of participants |
| Ocriplasmin 125µg | PVD Induction | 13.3 percentage of participants |
| Sham Injection | PVD Induction | 30.8 percentage of participants |
p-value: 0.13195% CI: [0.001, 999.999]Fisher Exact
p-value: 0.6795% CI: [0.132, 2.4]Fisher Exact
p-value: 0.37295% CI: [0.07, 1.703]Fisher Exact