Aflibercept Injection for Proliferative Diabetic Retinopathy

University of Oklahoma (OU)

Status and phase: Completed; Phase 2

Conditions: Vitreous Hemorrhage

Treatments: Other: Standard Vitrectomy; Drug: Intravitreal Aflibercept Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT01805297

2148 (Other Identifier)

Details and patient eligibility

About

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

Full description

Patients who need Pars Plana Vitrectomy surgery, and agree to participate in this study will receive an injection of 2.0mg aflibercept 4 to 6 days before Vitrectomy surgery. Half of these patients will be randomized to receive another injection of 2.0mg aflibercept immediately after their surgery. Postoperative patient visits in this study will be at 1 day, and at weeks 1, 4, 16 and 24, and at any other times as deemed necessary by the Investigator.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Vitrectomy with Aflibercept Injection

Active Comparator group

Description:

Preoperative 2.0mg intravitreal aflibercept and vitrectomy with intraoperative 2.0mg intravitreal aflibercept injection.

Treatment:

Drug: Intravitreal Aflibercept Injection

Standard Vitrectomy

Active Comparator group

Description:

Preoperative 2.0mg intravitreal aflibercept and standard of care vitrectomy.

Treatment:

Other: Standard Vitrectomy