Phase 2
N=51
A Multicenter Study to Compare Multiple Doses of Intravitreal Microplasmin Versus Sham Injection for Treatment of Patients With Diabetic Macular Edema (DME)
Diabetic Macular Edema
Bottom Line
View on ClinicalTrials.gov: NCT00412451 ↗Enrolled (actual)
51
Serious AEs
37.3%
Results posted
Sep 2013
Primary outcome: Primary: PVD Induction — 0; 20; 13.3; 30.8 percentage of participants — p=0.131
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ocriplasmin (Drug); Sham injection (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- ThromboGenics
- Primary completion
- Jan 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PVD Induction |
0; 20; 13.3; 30.8 | 0.131 |
Summary
A multicenter study to compare multiple doses of intravitreal microplasmin for non-surgical PVD induction for treatment of patients with DME.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00412451). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.