Active not recruitingOBSERVATIONAL

Observational Study of Adult Participants With Diabetic Macular Edema and Suboptimal Response to Anti-Vascular Endothelial Growth Factor Treated With Dexamethasone Intravitreal Implant

This study is for adults who have an eye condition called Diabetic Macular Edema (DME), which can cause blurry vision due to diabetes. These patients have already tried another common treatment, called anti-VEGF injections, but haven't seen enough improvement. The study focuses on a different approved medicine, a dexamethasone implant, which is placed inside the eye and slowly releases medication over time. Researchers want to see how these patients fare when treated with the dexamethasone implant as part of their usual care. It's an "observational study," meaning doctors will treat patients as they normally would, and researchers will simply collect information. About 327 people from around the world will be included, and their progress will be followed for 18 months after receiving the implant. This study aims to understand how this treatment works in a real-world setting without adding extra appointments or tests for patients.

At a glance

Status

Active not recruiting

Sponsor

AbbVie

Enrolment target

236

Start

30 Oct 2023

Estimated completion

01 Dec 2026

Diabetic Macular Edema

What is this study about?

This study is looking at a common eye problem called Diabetic Macular Edema (DME). This happens when diabetes damages the tiny blood vessels in the light-sensitive part at the back of your eye, called the retina. This can lead to swelling and blurry vision. If you have DME, your doctor might first suggest treatments called anti-VEGF injections. However, for some people, these injections don't work as well as hoped.

For those who haven't fully responded to anti-VEGF treatment, another option is an approved medicine called a dexamethasone intravitreal implant. This is a tiny device that your eye doctor places into your eye. It slowly releases an anti-inflammatory medicine called dexamethasone over time to help reduce the swelling. This study wants to understand how adults with DME who haven't responded well to anti-VEGF treatment do when they receive this dexamethasone implant as part of their regular doctor's visits.

This is an "observational study," which means that the doctors will decide to use the dexamethasone implant based on what they think is best for *you*, just as they would normally. The researchers will then simply collect information on how your eye responds to this treatment over 18 months. This helps them understand how the treatment works for patients in everyday medical practice, rather than in a highly controlled experiment. They expect to include about 327 people globally.

Key takeaways

The study focuses on adults with blurry vision from diabetes (Diabetic Macular Edema).
It's for people whose previous anti-VEGF injections didn't fully improve their vision.
The study watches how a dexamethasone implant works as part of routine care.
There are no extra doctor visits or tests required for participants.
About 327 people globally will be followed for 18 months.

Who may be eligible?

To be included in this study, you need to be an adult with Diabetic Macular Edema (DME) in at least one eye that your doctor has decided to treat with the dexamethasone implant. Your affected eye must have already received between 3 and 9 anti-VEGF injections in the past year, but still hasn't fully improved from that treatment. The decision for you to receive the dexamethasone implant must be made by your doctor as part of their normal care for your condition.

You would *not* be able to join if you have other eye problems that could cause blurry vision or swelling, apart from cataracts. This includes recent eye surgery (within the last 60 days) or certain laser treatments to your eye in the last 3 months. You also can't have poorly controlled eye pressure (glaucoma) or an active eye infection.

Also, if you've already had steroid injections in your eye before, or if you have certain types of artificial lenses from a complicated cataract surgery, you wouldn't be able to join. Finally, if there are any medical reasons why the dexamethasone implant wouldn't be suitable for you, you also wouldn't be eligible.

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 an adult with Diabetic Macular Edema (DME) in one eye?
Has your doctor prescribed the dexamethasone implant for your DME?
Have you already had 3 to 9 anti-VEGF injections in that eye in the last year, with less than ideal results?
Do you have any other serious active eye conditions (besides cataracts) or recent eye surgery in that eye?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you won't have any extra appointments or tests beyond what your own doctor already plans for your eye condition. The study is simply observing how you respond to the dexamethasone implant as part of your normal care. Your doctor will decide to give you the dexamethasone implant because they believe it's the right treatment for you. After you receive the implant, the study will follow your progress for 18 months, collecting information from your regular eye doctor visits. Only one of your eyes will be included in the study's evaluation.

Potential risks and benefits

Because this is an observational study, there are no additional treatments or procedures that are exclusive to the study. You'll receive the dexamethasone implant because your doctor has decided it's the best course of action for your eye condition, so potential benefits and risks are those associated with this approved treatment. The potential benefit is that the implant may improve your vision by reducing swelling in your eye. Potential risks will be discussed by your doctor and are generally those associated with any intravitreal injection or steroid use, such as increased eye pressure or cataract formation. You will always have the right to withdraw from the study at any time without affecting your medical care.

Locations (54)

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

Uza /Id# 255831
Verified postcode
Edegem, Belgium
CHU Saint Pierre /ID# 257650
Verified postcode
Brussels, Belgium
Universitair Ziekenhuis Brussel /ID# 255324
Verified postcode
Jette, Belgium
Ziekenhuis Oost-Limburg, Campus St.-Jan /ID# 255934
Verified postcode
Genk, Belgium
Vitaz /Id# 265553
Verified postcode
Sint-Niklaas, Belgium
CHR de la Citadelle /ID# 257254
Verified postcode
Liège, Belgium
Shenzhen Eye Hospital /ID# 262954
Verified postcode
Shenzhen, China
Tongji Hospital /ID# 270275
Verified postcode
Wuhan, China
Xi'an Fourth Hospital /ID# 262972
Verified postcode
Xi'an, China
Qingdao Eye Hospital Of Shandong First Medical University /ID# 262756
Verified postcode
Qingdao, China
West China Hospital, Sichuan University /ID# 262745
Verified postcode
Chengdu, China
MVZ Augenzentrum am Berliner Ring /ID# 267412
Verified postcode
Würzburg, Germany

Common questions

What is Diabetic Macular Edema (DME)?

DME is an eye condition caused by diabetes, where fluid leaks into the part of your eye responsible for sharp central vision, causing it to swell and making your sight blurry.

What is an anti-VEGF injection?

Anti-VEGF injections are a common treatment for DME that help stop new, leaky blood vessels from growing in your eye and reduce fluid buildup.

What is the dexamethasone implant?

It's a tiny, approved medicine that your eye doctor places inside your eye. It slowly releases an anti-inflammatory drug called dexamethasone to reduce swelling caused by DME.

Will I have extra doctor visits for this study?

No, this study will only collect information from your already scheduled appointments. You won't have any extra visits just for the study.

What does 'observational' mean in a study?

It means researchers are simply watching and collecting information about how patients do with a treatment they're already receiving as part of their regular care. There are no special study treatments.