Aflibercept Injection for Proliferative Diabetic Retinopathy

Vitreous Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01805297
• Other study ID #: 2148
• Status: Completed
• Phase: Phase 2
• Start date: March 2013
• Est. completion date: November 2015

Study information

• Verified date: December 2023
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 2015
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Hemorrhage
• Retinal Diseases
• Vitreous Hemorrhage

Intervention

Drug:
• Intravitreal Aflibercept Injection
One time 2.0mg aflibercept injection, following pars plana vitrectomy.

Other:
• Standard Vitrectomy
Surgical intervention

Locations

Country	Name	City	State
United States	Dean McGee Eye Institute	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Resolved Post-operative Vitreous Hemorrhage.	Percentage of patients who had no vitreous hemorrhage before or at week 24	24 weeks
Secondary	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
Secondary	Need for Any Additional Surgical Intervention.		24 weeks
Secondary	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