Aflibercept Injection for Proliferative Diabetic Retinopathy
United States12 participantsStarted 2013-03
Plain-language summary
To evaluate the ocular and systemic safety of intravitreal aflibercept injection in patients undergoing Pars Plana Vitrectomy for Proliferative Diabetic Retinopathy.
Who can participate
Age range18 Years
SexALL
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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 intraocu…
What they're measuring
1
Rate of Resolved Post-operative Vitreous Hemorrhage.