Non-Proliferative Diabetic Retinopathy
Circle Study
About The Study:
Principal Investigator: Yevgeniy Shildkrot, MD
Sponsored by ThromboGenics, the purpose of this study is to assess the efficacy and safety of up to three intravitreal injections of an investigational drug, ocriplasmin, in subjects with moderately severe to very severe NPDR, to induce total PVD in order to reduce the risk of disease progression to PDR.
All participants will be randomized to one of three study groups:
- Group A – 0.0625 mg ocriplasmin administered by intravitreal injection every 4 weeks, 3 injections total
- Group B – 0.125 mg ocriplasmin administered by intravitreal injection every 4 weeks, 3 injections total
- Group C—sham injections every 4 weeks
Participants participating in this study will make up to 13 scheduled study visits over a period of 24 months. Each visit will last anywhere from 2-5 hours.
Key Inclusion Criteria:
- Age ≥ 18 years
- BCVA of 20/50 or better in the study eye
- BCVA of 20/400 or better in fellow eye
- Hb1ac ≤ 12%
- Moderately severe to very severe NPDR
- No evidence of total PVD in the study eye
Key Exclusion Criteria:
- History of or current ocular condition in the study eye that may interfere with the assessment of the progression to PDR
- Clinically significant centre-involving DME in the study eye
- Clinically significant CME in the study eye
- Presence of ERM in study eye
- Presence of foveal ischemia, macular vascularization or peripheral non-perfusion in the study eye
- Presence of pre-retinal or vitreous hemorrhage in the study eye
- Presence of iris or angle neovascularization in the study eye
- Open angle glaucoma or uncontrolled glaucoma—IOP ≥ 26mmHg
For additional information about the trials or to refer a patient, contact the study coordinators:
- Ashton Leone, MPH at (434) 243-5737 or aml7q@virginia.edu
- Tamika Mercer at (434) 243-2852 or tmm2v@virginia.edu