Aflibercept Injection for Proliferative Diabetic Retinopathy
Condition: Vitreous Hemorrhage
MeSH terms: Retinal Diseases; Diabetic Retinopathy; Vitreous Hemorrhage; Hemorrhage
Intervention: Intravitreal Aflibercept Injection; Standard Vitrectomy
Intervention description: One time 2.0mg aflibercept injection, following pars plana vitrectomy.; Surgical intervention
Intervention MeSH terms: Aflibercept
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Proliferative Diabetic Retinopathy

Summary:

      To evaluate the ocular and systemic safety of intravitreal aflibercept injection in patients
      undergoing Pars Plana Vitrectomy for Proliferative Diabetic Retinopathy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ability to provide written informed consent and comply with study assessments for the
             full duration of the study

          -  Age > 18 years

          -  Diagnosed with proliferative diabetic retinopathy (PDR) requiring pars plana
             vitrectomy (PPV)

          -  Best corrected visual acuity in the study eye between 20/40 to light perception (LP)
             using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart

        Exclusion Criteria:

          -  Pregnancy (positive urine pregnancy test) or lactation

          -  Premenopausal women not using adequate contraception. The following are considered
             effective means of contraception: surgical sterilization or use of oral
             contraceptives, barrier contraception with either a condom or diaphragm in conjunction
             with spermicidal gel, an intrauterine device (IUD), or contraceptive hormone implant
             or patch.

          -  Participation in a study of an investigational drug or device within the past 30 days
             prior to enrolling in the study

          -  For previously treated subjects -

          -  Prior treatment with anti-vascular endothelial growth factor (anti-VEGF) therapy in
             the study eye within 28 days of Screening

          -  Prior treatment with triamcinolone in the study eye within 6 months of Screening.

          -  Prior treatment with dexamethasone in the study eye within 30 days of Screening

          -  Intraocular surgery (including cataract surgery) in the study eye within 2 months
             preceding Baseline

          -  History of vitrectomy surgery, submacular surgery, or other surgical intervention for
             PDR in the study eye

          -  Active intraocular inflammation (grade trace or above) in the study eye

          -  History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the
             study eye

          -  Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either
             eye

          -  Uncontrolled glaucoma in the study eye (defined as intraocular pressure (IOP) ≥ 30
             mmHg despite treatment with anti-glaucoma medication)

          -  History of cerebral vascular accident, myocardial infarction, transient ischemic
             attacks within 6 months of study enrollment.

          -  History of allergy to fluorescein, indocyanine green (ICG) or iodine, not amenable to
             treatment

          -  Presence of macular traction

          -  Uncontrolled hypertension (e.g., 120/200 mmHg) prior to surgery (PPV)

          -  Concomitant use of any systemic anti-VEGF therapy