Aflibercept Injection for Proliferative Diabetic Retinopathy

• Status: Completed
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Oklahoma
• Treatments: Aflibercept

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