Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Age >= 18 years with proliferative diabetic retinopathy (PDR) and tractional retinal detachment (TRD) threatening or involving the fovea.
Diagnosis of diabetes mellitus (type 1 or type 2)
At least one eye meets the study eye criteria
One eye per patient will be included
Able and willing to provide informed consent prior to any study-related procedures
Best corrected visual acuity 20/40 or less
Willing and able to comply with clinic visits and study-related procedures
U.S. patients will be required to have a Health Insurance Portability and Accountability Act (HIPAA) authorization; in other countries, as applicable according to national laws

Exclusion Criteria:

Ocular Exclusion Criteria

The following exclusions apply to the study eye only (i.e., they may be present for the non-study eye):

TRD is considered to be due to a cause other than diabetes.
An ocular condition is present such that, in the opinion of the investigator, visual acuity loss would not improve from resolution of TRD (e.g., foveal atrophy, pigment abnormalities, dense subfoveal hard exudates, nonretinal condition, optic atrophy).
An ocular condition is present (other than diabetes) that, in the opinion of the investigator, might affect retinal status or alter visual acuity during the course of the study (e.g., retinal vein occlusion, uveitis or other ocular inflammatory disease, glaucoma, etc.)
History of treatment for diabetic macular edema or diabetic retinopathy at any time in the past 4 months with anti-vascular endothelial growth factor (VEGF) drugs.
History of major ocular surgery (including vitrectomy, cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior 4 months of randomization.
History of neodymium-doped yttrium aluminium garnet (YAG) capsulotomy performed within 2 months prior to randomization.
Intraocular pressure >= 25 mmHg.
Exam evidence of external ocular infection, including conjunctivitis, chalazion, or significant blepharitis
An ocular condition is present (other than diabetes) that, in the opinion of the investigator, might affect retinal status or including hypertension, cardiovascular disease, and glycemic control.

Systemic Exclusion Criteria

A participant is not eligible if any of the following exclusion criteria are present:

Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.
A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including hypertension, cardiovascular disease, and glycemic control).
Participation in an investigational trial within 30 days of randomization that involved treatment with any drug that has not received regulatory approval at the time of study entry.
Known allergy to any component of the study drug.
Blood pressure > 180/110 mmHg (systolic above 180 or diastolic above 110).
Major surgery within 28 days prior to randomization or major surgery planned during the next 6 months.
Myocardial infarction, other cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization.
Systemic anti-VEGF or VEGF treatment within 4 months prior to randomization.
For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 12 months.
Participant is expecting to move out of the area of the clinical center to an area not covered by another clinical center during the first 12 months of the study.
Participation in an investigational trial within 30 days of randomization that involved treatment with any drug that has not received regulatory approval at the time of study entry.
Known allergy to any component of the study drug.
Blood pressure > 180/110 mmHg (systolic above 180 or diastolic above 110).
Major surgery within 28 days prior to randomization or major surgery planned during the next 6 months.
Myocardial infarction, other cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization.
Systemic anti-VEGF or VEGF treatment within 4 months prior to randomization.
For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 12 months.
Participant is expecting to move out of the area of the clinical center to an area not covered by another clinical center during the first 12 months of the study.
History of blood diseases associated with abnormal coagulation.
Anti-coagulant therapy (warfarin or heparin).