Clinical trial NCT01805297: Aflibercept Injection for Proliferative Diabetic Retinopathy
Official title: Intravitreal Aflibercept Injection as a Surgical Adjuvant in Severe Proliferative Diabetic Retinopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Vitreous Hemorrhage
Keywords: Proliferative Diabetic Retinopathy
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2013-03-06
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Rate of Resolved Post-operative Vitreous Hemorrhage.
timeFrame: 24 weeks
Secondary outcomes:
measure: Mean Change in Visual Acuity
timeFrame: 24 weeks
measure: Need for Any Additional Surgical Intervention.
timeFrame: 24 weeks
measure: Changes in Mean Central Retinal Thickness.
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: Dean McGee Eye Institute
state: Oklahoma
Study officials:
affiliation: Dean McGee Eye Institute
name: Robert E Leonard, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dean McGee Eye Institute
name: Vinay A Shah, MD
role: PRINCIPAL_INVESTIGATOR
References: