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Monoclonal Antibodies

Aflibercept for Diabetic Macular Edema

Phase 4

Waitlist Available

Led By Sean Adrean, M.D.

Research Sponsored by Retina Consultants of Orange County

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Men or women ≥18 years of age with type 1 or type 2 diabetes mellitus

Have a previous history of vitrectomy surgery

Must not have

Evidence of macular edema due to any cause other than diabetes mellitus in either eye

History of glaucoma filtration surgery in the past

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial investigates the effects of different treatments on patients with diabetic macular edema (DME) who have undergone vitrectomy surgery. The study found that anti-VEGF therapy, particularly ran

Who is the study for?

This trial is for patients with diabetic macular edema who have had a vitrectomy surgery. It's designed to see if high doses of Aflibercept can better improve their condition, considering the faster clearance of medication from eyes that have undergone this procedure.

What is being tested?

The study tests whether a higher dose (8 mg) of Aflibercept, an anti-VEGF therapy, can provide better outcomes for those with diabetic macular edema after vitrectomy surgery compared to standard treatments.

What are the potential side effects?

Aflibercept may cause eye-related side effects such as redness, irritation, or blurred vision. There might also be risks associated with intravitreal injections like eye infection or increased intraocular pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 or older with type 1 or type 2 diabetes.

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I have had vitrectomy surgery in the past.

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My vision in the study eye ranges from 20/25 to 20/400 due to DME.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have swelling in the retina not caused by diabetes.

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I have had surgery for glaucoma before.

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I am willing to use effective birth control during the study.

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I haven't had eye inflammation or infection in the last 6 weeks.

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I have had uveitis in my eye without a known cause.

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My eye condition is affecting my central vision.

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My eye has signs of abnormal blood vessel growth, bleeding, or detachment.

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I have had a corneal transplant or suffer from corneal dystrophy in one of my eyes.

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My eye condition is unlikely to improve even if the swelling reduces due to severe damage.

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My diabetes is not under control, with an HbA1c level over 14%.

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I haven't had a stroke or heart attack in the last 24 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Visual acuity changes

Secondary study objectives

Central Macular Thickness

Time Interval

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

1Treatment groups

Active Control

Group I: Patients with previous vitrectomy and diabetic macular edema treated with high dose afliberceptActive Control1 Intervention

Identify patients that have had a previous vitrectomy and have DME that requires anti-VEGF therapy. Then using a treat-extend-stop protocol6,7 that I previously published, treat patients with DME using high dose aflibercept, until the fluid has resolved and then extend the time interval in between treatments for those patients, while maintaining a fluid-free macula.

0 / 14Eligibility criteria met