Aflibercept Injection for Proliferative Diabetic Retinopathy

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

Detailed Description
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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.

Official Title
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Intravitreal Aflibercept Injection as a Surgical Adjuvant in Severe Proliferative Diabetic Retinopathy

Conditions
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Vitreous Hemorrhage

Intervention / Treatment
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* Drug: Intravitreal Aflibercept Injection
* Other: Standard Vitrectomy


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vitrectomy with Aflibercept Injection<br>Preoperative 2.0mg intravitreal aflibercept and vitrectomy with intraoperative 2.0mg intravitreal aflibercept injection. | Drug: Intravitreal Aflibercept Injection<br>* One time 2.0mg aflibercept injection, following pars plana vitrectomy.<br>* Other names: Eylea;|
| Active Comparator: Standard Vitrectomy<br>Preoperative 2.0mg intravitreal aflibercept and standard of care vitrectomy. | Other: Standard Vitrectomy<br>* Surgical intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Resolved Post-operative Vitreous Hemorrhage. | Percentage of patients who had no vitreous hemorrhage before or at week 24 | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in Visual Acuity | 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. | 24 weeks | 
| Need for Any Additional Surgical Intervention. |  | 24 weeks | 
| Changes in Mean Central Retinal Thickness. | 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. | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Proliferative Diabetic Retinopathy