This trial is active, not recruiting.

Condition vitreous hemorrhage
Treatments intravitreal aflibercept injection, standard vitrectomy
Phase phase 2
Sponsor University of Oklahoma
Start date March 2013
End date February 2014
Trial size 12 participants
Trial identifier NCT01805297, VS-12-01


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(Active Comparator)
Preoperative 2.0mg intravitreal aflibercept and vitrectomy with intraoperative 2.0mg intravitreal aflibercept injection.
intravitreal aflibercept injection Eylea
One time 2.0mg aflibercept injection, following pars plana vitrectomy.
(Active Comparator)
Preoperative 2.0mg intravitreal aflibercept and standard of care vitrectomy.
standard vitrectomy
Surgical intervention

Primary Outcomes

Rate and amount of post-operative vitreous hemorrhage.
time frame: 24 weeks

Secondary Outcomes

Mean change in visual acuity
time frame: 24 weeks
Need for any additional surgical intervention.
time frame: 24 weeks
Changes in mean central retinal thickness.
time frame: 24 weeks
Changes in mean proliferative diabetic retinopathy (PDR) grading.
time frame: 24 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Intravitreal Aflibercept Injection as a Surgical Adjuvant in Severe Proliferative Diabetic Retinopathy
Principal investigator Robert E Leonard, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by University of Oklahoma.