The purpose of this study is to assess the efficacy and safety of up to 3 intravitreal injections of ocriplasmin (0.0625mg or 0.125mg), in subjects with moderate to very severe non-proliferative diabetic retinopathy (NPDR), to induce total posterior vitreous detachment (PVD) in order to reduce the risk of disease progression to proliferative diabetic retinopathy (PDR).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
48
Up to 3 intravitreal injections of ocriplasmin 0.0625mg approximately 1 month apart
Up to 3 intravitreal injections of ocriplasmin 0.125mg approximately 1 month apart
3 sham injections approximately 1 month apart. No actual injections. No medication is used.
Unnamed facility
Phoenix, Arizona, United States
Number of Subjects With Total PVD by the Month 3 Visit
Total PVD should be confirmed on both B-scan ultrasound and spectral domain optical coherence tomography (SD-OCT), as assessed by the masked central reading centres
Time frame: Month 3
Number of Subjects With Ocular Treatment-emergent Adverse Events in the Study Eye
Adverse events were identified by ophthalmic assessments (including BCVA assessment, full ophthalmic examination and ocular imaging) and by subject reporting
Time frame: From first injection until the end of the study (Month 24)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Campbell, California, United States
Unnamed facility
Irvine, California, United States
Unnamed facility
Loma Linda, California, United States
Unnamed facility
Santa Ana, California, United States
Unnamed facility
Rapid City, South Dakota, United States
Unnamed facility
McAllen, Texas, United States
Unnamed facility
San Antonio, Texas, United States
Unnamed facility
Charlottesville, Virginia, United States
Unnamed facility
Brno, Czechia
...and 28 more locations