A Phase 2 interventional study of ocriplasmin and Sham injection in Diabetic Macular Edema, sponsored by ThromboGenics. Completed at 15 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-12-17.
Sponsored by ThromboGenics (part of Oxurion) · Phase 2, Interventional, and Treatment
A multicenter study to compare multiple doses of intravitreal microplasmin for non-surgical PVD induction for treatment of patients with DME.
791 studies on the registry are indexed under Diabetic Retinopathy; 139 are open to participants now.
This study's enrollment of 51 is below the median of 80 across 491 interventional studies indexed under Diabetic Retinopathy.
Browse Diabetic Retinopathy studies →ThromboGenics is the lead sponsor of 28 studies on the registry; none are open to participants now.
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Exclusion Criteria include:
25µg ocriplasmin intravitreal injection versus sham injection
Drug: ocriplasmin
75µg ocriplasmin intravitreal injection versus sham injection
Drug: ocriplasmin
125µg ocriplasmin intravitreal injection versus sham injection
Drug: ocriplasmin
Sham injection
Other: Sham injection
Intravitreal injection, single administration
Also known as: microplasmin
Sham intravitreal injection
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
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
| Milestone | Ocriplasmin 25µg | Ocriplasmin 75µg | 0criplasmin 125µg | Sham Injection |
|---|---|---|---|---|
| Started | 8 | 15 | 15 | 13 |
| Completed | 8 | 15 | 14 | 11 |
| Not completed | 0 | 0 | 1 | 2 |
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)
| percentage of participants | Ocriplasmin 25µg | Ocriplasmin 75µg | Ocriplasmin 125µg | Sham Injection |
|---|---|---|---|---|
| PVD Induction | 0 | 20 | 13.3 | 30.8 |
Collected over AEs/SAEs were collected from injection day up to Month 12 post-injection. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ocriplasmin 25µg | — | 1/8 (12.5%) | 1/8 (12.5%) |
| Ocriplasmin 75µg | — | 4/15 (26.7%) | 4/15 (26.7%) |
| Ocriplasmin 125µg | — | 5/15 (33.3%) | 5/15 (33.3%) |
| Sham Injection | — | 9/13 (69.2%) | 7/13 (53.8%) |
| Event | Ocriplasmin 25µg | Ocriplasmin 75µg | Ocriplasmin 125µg | Sham Injection |
|---|---|---|---|---|
| UrosepsisInfections and infestations | 1/8 | 0/15 | 0/15 | 0/13 |
| maculopathyEye disorders | 0/8 | 0/15 | 0/15 | 1/13 |
| Angina pectorisCardiac disorders | 0/8 | 0/15 | 0/15 | 1/13 |
| Atrioventricular block completeCardiac disorders | 0/8 | 0/15 | 0/15 | 1/13 |
| Cardiac arrestCardiac disorders | 0/8 | 0/15 | 0/15 | 1/13 |
| Myocardial infactionCardiac disorders | 0/8 | 0/15 | 0/15 | 1/13 |
| Myocardial ischaemiaCardiac disorders | 0/8 | 0/15 | 0/15 | 1/13 |
| Intestinal obstructionGastrointestinal disorders | 0/8 | 0/15 | 0/15 | 1/13 |
| Oesophageal varices haemorrhageGastrointestinal disorders | 0/8 | 0/15 | 0/15 | 1/13 |
| OsteoarthritisMusculoskeletal and connective tissue disorders | 0/8 | 0/15 | 0/15 | 1/13 |
| Event | Ocriplasmin 25µg | Ocriplasmin 75µg | Ocriplasmin 125µg | Sham Injection |
|---|---|---|---|---|
| UrosepsisInfections and infestations | 1/8 | 0/15 | 0/15 | 0/13 |
| Angina PectorisCardiac disorders | 0/8 | 0/15 | 0/15 | 1/13 |
| Atrioventricular block completeCardiac disorders | 0/8 | 0/15 | 0/15 | 1/13 |
| Cardiac arrestCardiac disorders | 0/8 | 0/15 | 0/15 | 1/13 |
| Myocardial infarctionCardiac disorders | 0/8 | 0/15 | 0/15 | 1/13 |
| MaculopathyEye disorders | 0/8 | 0/15 | 0/15 | 1/13 |
| OsteoarthritisMusculoskeletal and connective tissue disorders | 0/8 | 0/15 | 0/15 | 1/13 |
| Myocardial ischaemiaCardiac disorders | 0/8 | 0/15 | 0/15 | 1/13 |
| Macular oedemaEye disorders | 0/8 | 1/15 | 0/15 | 0/13 |
| Optic disc vascular disorderEye disorders | 0/8 | 1/15 | 0/15 | 0/13 |
| Age, Continuous(years) | Ocriplasmin 25µg | Ocriplasmin 75µg | Ocriplasmin 125µg | Sham Injection | Total |
|---|---|---|---|---|---|
| Mean | 61.6 ± 9.8 | 67.3 ± 8.8 | 61.7 ± 13.4 | 69.9 ± 6.2 | 63.9 ± 11.1 |
| Sex: Female, Male(Participants) | Ocriplasmin 25µg | Ocriplasmin 75µg | Ocriplasmin 125µg | Sham Injection | Total |
|---|---|---|---|---|---|
| Female | 5 | 6 | 4 | 4 | 19 |
| Male | 3 | 9 | 11 | 9 | 32 |
This study is completed, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Microplasmin