Active not recruitingPHASE4INTERVENTIONAL

Treat & Extend Versus Fixed Dosing With Faricimab for Management of Diabetic Macular Edema: A Pragmatic, Multi-center, Open-label, Randomized, Controlled Trial

This research study is investigating the most effective way to treat an eye condition called diabetic macular edema (DME), which can cause blurry vision for people with diabetes. We are comparing two approaches for giving a medication called faricimab. One approach is a 'treat and extend' method, where the time between doses changes based on how well a patient is doing. The other is a 'fixed dosing' method, where the medication is given at regular, set intervals. The aim is to find out which method provides the best results for patients in a real-world setting, helping them manage their eyesight more effectively and potentially reducing the number of clinic visits needed.

At a glance

Status

Active not recruiting

Phase

PHASE4

Sponsor

McMaster University

Enrolment target

446

Start

01 May 2023

Estimated completion

01 Dec 2026

Diabetic Macular Edema

What is this study about?

Diabetic macular edema (DME) is an eye condition that can affect people with diabetes. It happens when high blood sugar levels damage the tiny blood vessels in the retina, the light-sensitive tissue at the back of your eye. This damage can cause fluid to leak into the macula, the part of your retina responsible for sharp, central vision. When the macula swells, your vision can become blurry or distorted, making it hard to read, drive, or recognise faces.

This study is looking at a medicine called faricimab, which is already approved for treating DME. Rather than just testing if the medicine works, we want to find out the best way to give it to patients. We're comparing two main ways: a 'treat and extend' approach, where the time between treatments can change based on how your eye is responding, and a 'fixed dosing' approach, where you get treatments on a regular, set schedule. The goal is to see which method helps people maintain their best vision and provides the most practical and effective treatment in their daily lives.

By understanding the best way to use faricimab, doctors can tailor treatments more effectively for people with DME. This could mean getting fewer injections while still keeping the condition under control, improving quality of life, and helping to preserve eyesight for longer. This study will provide important information for doctors and patients about managing DME.

Key takeaways

Exploring the best way to use an existing medicine for diabetic macular edema.
Comparing two different injection schedules: 'treat and extend' vs. 'fixed dosing'.
Aims to improve treatment effectiveness and patient convenience.
Participation involves regular eye checks and injections.
Potential benefits include close monitoring and access to treatment.
Risks are generally low, similar to standard eye injections.

Who may be eligible?

To be part of this study, you need to be at least 18 years old and have been diagnosed with either type 1 or type 2 diabetes. You must also have swelling in the central part of your macula (the sharp-vision area of your eye) due to diabetic macular edema, which we can confirm with an eye scan. Your eyesight should be affected by this swelling, ranging from slightly blurry to quite blurry, and your recent blood sugar control (HbA1c) should be good enough, below 10%.

There are also some reasons why you might not be able to join. For example, if you have active eye infections, certain severe diabetic eye problems like high-risk proliferative diabetic retinopathy, or other specific eye conditions like uncontrolled glaucoma. If you've recently had certain eye surgeries or received particular eye treatments (like some steroid injections or laser treatments) in the past few months, you might also not be eligible. We also can't include you if there's another reason for your macular swelling that isn't related to your diabetes.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years or older?
Do you have type 1 or type 2 diabetes?
Has an eye doctor told you that you have swelling due to diabetic macular edema?
Is your vision affected by this eye swelling?
Has your HbA1c (average blood sugar) been less than 10% in the last two months?
Have you not had certain eye surgeries or treatments in the last 3-6 months?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be randomly assigned to one of two treatment groups, meaning a computer will decide which treatment schedule you follow. Both groups will receive the study medicine, faricimab, as an injection into the eye. One group will get injections on a fixed, regular schedule, while the other will have their injection schedule adjusted based on how their eye is responding to the treatment.

You will have regular clinic visits for eye examinations, scans (like OCT scans to check the swelling), and vision tests. These visits will help us monitor your eye health and the effectiveness of the treatment. The total duration of your participation in this study will be decided by the researchers, to understand the long-term effects of the treatments. You can withdraw from the study at any time.

Potential risks and benefits

Taking part in this study may offer some potential benefits, such as receiving close monitoring of your eye condition and access to an approved treatment (faricimab) that could help improve or maintain your vision. However, there are also potential risks associated with eye injections, including a small chance of infection, bleeding, or increased eye pressure, though these are rare. Like all medical procedures, it's possible you might experience side effects from the medication. You have the right to withdraw from the study at any time without giving a reason, and your regular medical care will not be affected.

Locations (46)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Retinal Consultants Medical Group Inc.
Verified postcode
Modesto, United States
Vitreo-Retina Medical Group
Verified postcode
Sacramento, United States
University Retina and Macula Associates
Verified postcode
Oak Forest, United States
Eye Associates of Northeast Louisiana Dba Haik Humble Eye Center
Verified postcode
West Monroe, United States
Mississippi Retina Associates
Verified postcode
Jackson, United States
Austin Retina Associates
Verified postcode
Austin, United States
Retina Consultants of Texas
Verified postcode
Beaumont, United States
Retina & Vitreous of Texas
Verified postcode
Bellaire, United States
Retina Consultants of Houston, dba Retina Consultants of Texas
Verified postcode
Bellaire, United States
Valley Retina Institute
Verified postcode
McAllen, United States
Retina Consultants of Houston, dba Retina Consultants of Texas
Verified postcode
San Antonio, United States
Eye Clinic Albury Wodonga
Verified postcode
Albury, Australia

Common questions

What is diabetic macular edema (DME)?

DME is an eye condition where swelling occurs in the macula (the central part of your retina) due to damaged blood vessels caused by diabetes, leading to blurred vision.

What is faricimab?

Faricimab is a medicine given as an injection into the eye to treat conditions like DME by reducing fluid leakage and inflammation.

What is 'treat and extend' dosing?

This is a treatment approach where the time between your eye injections is gradually increased or decreased based on how well your eye condition is responding, aiming for fewer injections over time.

What is 'fixed dosing'?

This means you receive your eye injections on a regular, set schedule, for example, every four or eight weeks, regardless of minor changes in your eye condition.

Will I know which treatment group I'm in?

Yes, this is an 'open-label' study, which means both you and your study doctor will know which treatment schedule you are following (either 'treat and extend' or 'fixed dosing').