Aflibercept Injection for Proliferative Diabetic Retinopathy

Phase 2

Completed

Conditions: Vitreous Hemorrhage

Interventions: Other: Standard Vitrectomy
Drug: Intravitreal Aflibercept Injection

Registration Number: NCT01805297

Lead Sponsor: University of Oklahoma

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

Detailed 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 12

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Vitrectomy	Standard Vitrectomy	Preoperative 2.0mg intravitreal aflibercept and standard of care vitrectomy.
Vitrectomy with Aflibercept Injection	Intravitreal Aflibercept Injection	Preoperative 2.0mg intravitreal aflibercept and vitrectomy with intraoperative 2.0mg intravitreal aflibercept injection.

Primary Outcome Measures

Name	Time	Method
Rate of Resolved Post-operative Vitreous Hemorrhage.	24 weeks	Percentage of patients who had no vitreous hemorrhage before or at week 24

Secondary Outcome Measures

Name	Time	Method
Mean Change in Visual Acuity	24 weeks	Change in visual acuity measured using "Early Treatment of Diabetic Retinopathy Study" visual acuity charts and letter score difference from baseline to 6 month. A greater number indicates a higher increase in vision from the baseline score. A negative number would indicate that vision decreased.
Need for Any Additional Surgical Intervention.	24 weeks
Changes in Mean Central Retinal Thickness.	24 weeks	The amount of thickness change in microns from baseline to 6 month visit. A positive number indicates an increase in thickness and a negative number would indicate a decrease in thickness.