Aflibercept Injection for Proliferative Diabetic Retinopathy

NCT01805297 | Completed Phase 2 Results

• 1 other identifier: 2148
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Vitreous Hemorrhage

Keywords

Proliferative Diabetic Retinopathy

Outcome Measures

Primary Outcomes (1)

• Rate of Resolved Post-operative Vitreous Hemorrhage.

  Percentage of patients who had no vitreous hemorrhage before or at week 24

  24 weeks

Secondary Outcomes (3)

• Mean Change in Visual Acuity

  24 weeks

• Need for Any Additional Surgical Intervention.

  24 weeks

• Changes in Mean Central Retinal Thickness.

  24 weeks

Study Arms (2)

Vitrectomy with Aflibercept Injection

ACTIVE COMPARATOR

Preoperative 2.0mg intravitreal aflibercept and vitrectomy with intraoperative 2.0mg intravitreal aflibercept injection.

Drug: Intravitreal Aflibercept Injection

Standard Vitrectomy

ACTIVE COMPARATOR

Preoperative 2.0mg intravitreal aflibercept and standard of care vitrectomy.

Other: Standard Vitrectomy

Interventions

Intravitreal Aflibercept Injection DRUG

One time 2.0mg aflibercept injection, following pars plana vitrectomy.

Also known as: Eylea

Vitrectomy with Aflibercept Injection

Standard Vitrectomy OTHER

Surgical intervention

Standard Vitrectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

Dean McGee Eye Institute

Oklahoma City, Oklahoma, 73104, United States

Location

Related Publications (1)

• Dervenis P, Dervenis N, Smith JM, Steel DH. Anti-vascular endothelial growth factors in combination with vitrectomy for complications of proliferative diabetic retinopathy. Cochrane Database Syst Rev. 2023 May 31;5(5):CD008214. doi: 10.1002/14651858.CD008214.pub4.

  PMID: 37260074 DERIVED

MeSH Terms

Conditions

Vitreous Hemorrhage

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Eye Hemorrhage; Eye Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Robert E. Leonard, II, MD
• Organization: Dean McGee Eye Institute

sonny-icks@dmei.org

405-271-6060

Study Officials

• Robert E Leonard, MD

  Dean McGee Eye Institute

  PRINCIPAL INVESTIGATOR

• Vinay A Shah, MD

  Dean McGee Eye Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2013
• First Posted: March 6, 2013
• Study Start: March 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: November 1, 2015
• Last Updated: December 27, 2023
• Results First Posted: September 13, 2017

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)