Variable Interval Versus Set Interval Aflibercept for DME

NCT02392364 | Completed Phase 4

• 1 other identifier: 2014-01-CRC
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to compare the safety and efficacy of intravitreal Eylea injections at a set interval, versus a variable dosing schedule (likely longer than one month), based on a specific individual's disease progression. There will be approximately 50 men and women at least 18 years of age, diagnosed with type 1 or type 2 diabetes, taking part in this study at 5 locations in the United States.

Conditions

Cystoid Macular Edema; Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

• BCVA Change

  Change in mean BCVA from baseline to week 52

  Week 0 to Week 52

Study Arms (2)

Variable Treatment Dosing Arm

ACTIVE COMPARATOR

Group 1 will receive injections every 4 weeks until diabetic macular edema on the OCT is decreased and stable. At that point, the length of time between injections may increase, depending on how the study eye is doing. The interval between study eye treatments may maintain, increase, or decrease once the variable treatment dosing has begun. This will be determined by an algorithm designed into a computer program

Drug: Intravitreal Aflibercept Injection

Monthly Treatment Arm

ACTIVE COMPARATOR

Group 2 will receive 5 intravitreal injections, monthly, for the first 5 months of the study. After those initial injections, visits/treatment will be every 8 weeks.

Drug: Intravitreal Aflibercept Injection

Interventions

Intravitreal Aflibercept Injection DRUG

Monthly Treatment Arm; Variable Treatment Dosing Arm

Eligibility Criteria

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

You may qualify if:

• Adults 18 years and older with Type 1 or Type 2 diabetes mellitus
• Patients with diabetic macular edema involving the center of the macular in the study eye (CST must measure at least 350µm on Heidelberg SDOCT, or 333µm on Cirrus SDOCT)
• Decrease in vision determined to be primarily due to DME in the study eye
• BCVA ETDRS letter score 78 to 24 (20/32 to 20/320) in the study eye
• Willing and able to comply with clinical visits and study related procedures
• Willing and able to provide signed informed consent

You may not qualify if:

• History of vitreoretinal surgery in the study eye
• Laser photocoagulation (panretinal or macular) in the study eye within 90 days of baseline
• Previous use of intraocular or periocular corticosteroids in the study eye within 90 days of baseline
• Any history of intravitreal aflibercept
• Active proliferative diabetic retinopathy (PDR) in the study eye
• History of idiopathic or autoimmune uveitis in the study eye
• Cataract surgery in the study eye within 90 days of baseline
• Aphakia in the study eye
• Yttrium aluminum garnet (YAG) capsulotomy in the study eye within 30 days of baseline
• Any intraocular surgery in the study eye within 90 days of day 1
• Vitreomacular traction or epiretinal membrane in the study eye that is thought to affect central vision
• Current iris neovascularization, vitreous hemorrhage, or traction retinal detachment in the study eye
• Pre-retinal fibrosis involving the macula in the study eye
• Uncontrolled glaucoma (defined as any patient who has had filtration surgery in the past, or likely to need filtration surgery in the future, or has IOP ≥30mmHg)
• Myopia of a spherical equivalent prior to any possible refractive or cataract surgery of ≥-8 diopters

Sponsors & Collaborators

• California Retina Consultants: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (2)

California Retina Consultants - Bakersfield

Bakersfield, California, 93039, United States

Location

California Retina Consultants - Santa Barbara Office

Santa Barbara, California, 93103, United States

Location

MeSH Terms

Conditions

Macular Edema

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Dilsher S Dhoot, MD

  California Retina Consultants

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2015
• First Posted: March 19, 2015
• Study Start: April 15, 2015
• Primary Completion: November 15, 2018
• Study Completion: November 15, 2018
• Last Updated: January 3, 2019

Record last verified: 2019-01

Locations

US (2)