A Study to Learn More About How Well 8 Milligram Aflibercept Works and How Safe it is in Chinese Participants With Diabetic Macular Edema

Clinicaltrials.gov Identifier:

nct06422507

Trial details

Trial date:

May 29, 2024 - December 30, 2025

Phase: 3

Birth sex

Age range

18 Years and Older

Accepts healthy volunteers

Condition(s) being studied:

Diabetic Macular Edema

What is the type of trial?

Interventional

What is the trial testing?

2 mg aflibercept (EYLEA, BAY 86-5321), 8 mg aflibercept (BAY 86-5321) (High Dose)

How many people are being enrolled?

333

Key Inclusion Criteria:

* Men or women ≥18 years of age

* Chinese participants with type 1 or type 2 diabetes mellitus and diabetic macular edema (DME) with central involvement defined as CST ≥300 µm (or ≥320 µm on Heidelberg Spectralis) in the study eye as determined by the reading center at the screening visit and confirmed by the site at baseline visit

* BCVA early treatment diabetic retinopathy study (ETDRS) letter score of 78 to 24 (approximate Snellen equivalent of 20/32 to 20/320) in the study eye at the screening and baseline visits with decreased vision determined to be primarily the result of DME

* Women of childbearing potential (WOCBP) or men who are sexually active with partners of childbearing potential must agree to use highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 4 months after the last administration of study intervention.

Key Exclusion Criteria:

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

* Active proliferative diabetic retinopathy in the study eye

* Panretinal laser photocoagulation (PRP) or macular laser photocoagulation in the study eye within 12 weeks (84 days) of the screening visit

* IVT anti-VEGF treatment (aflibercept, ranibizumab, bevacizumab, conbercept, faricimab, brolucizumab, pegaptanib sodium) in the study eye within 12 weeks (84 days) of the screening visit

* Previous use of topical steroids within 4 weeks (28 days) of the screening visit or of intraocular or periocular corticosteroids in the study eye within 16 weeks (112 days) of the screening visit, or ILUVIEN or OZURDEX IVT implants at any time

* Prior ocular investigational agents (that have not been approved) in either eye (e.g., IVT, suprachoroidal injections, ocular implants, etc.) at any time.

* Previous treatment with an investigational or approved intraocular gene therapy or cell therapy in either eye at any time.

Trial summary

Researchers are looking for a better way to treat people who have diabetic macular edema.

Diabetic macular edema (DME) is a diabetes-related eye disorder. In DME, the macula, which is the central part of the retina at the back of the eye, swells up resulting in vision problems. This happens due to leakage of fluid from damaged blood vessels.

The study treatment, 8 milligram (mg) aflibercept is injected into the eye. It works by blocking a protein called vascular endothelial growth factor (VEGF) which causes abnormal growth and leakage of blood vessels at the back of the eye.

A lower dose of aflibercept (2 mg) is already approved for the treatment of DME. Based on the findings of another study, the higher dose of aflibercept (8 mg) is expected to reduce the frequency of injections required for treating DME while being equally safe and working as well as the lower dose. The higher dose could make it easier to treat DME and improve quality of life for people with DME.

The main purpose of this study is to learn if high-dose (8 mg) aflibercept given every 16 weeks works as well as low-dose (2 mg) aflibercept given every 8 weeks in Chinese participants.

For this, the researchers will compare the change in participants' 'best corrected visual acuity' (BCVA) after 48 weeks of starting the treatment. BCVA is the clearest vision a participant can have with the help of corrective lenses, such as glasses. It will be measured by the number of letters the participant can read on an eye chart. This is known as their Early Treatment Diabetic Retinopathy Study (ETDRS) letter score.

Participants will be randomly (by chance) assigned to one of two treatment groups to receive study treatment as an injection into the eye up to Week 56:

* 2 mg aflibercept every 8 weeks after receiving 5 initial monthly doses

* 8 mg aflibercept every 16 weeks after receiving 3 initial monthly doses

Each participant will be in the study for around 63 weeks with up to 18 visits to the study site. This includes:

* one visit up to 21 days before the treatment starts during which the doctors will confirm that the participant can take part in the study

* 16 visits during which the treatment will be given. Most of these visits will have a gap of 4 weeks except for one visit that will happen a few days after the previous visit

* one visit 4 weeks after the treatment ends

During the study, the doctors and their study team will:

* check the participants' vision and their overall eye health using different eye tests

* check participants' health by performing tests such as blood and urine tests

* ask the participants questions about the disease and study treatment and how these impact their quality of life

* ask the participants what adverse events they are having An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective of whether they think they are related to the study treatment.

Access to study treatment after the end of this study is not planned. Participants can switch to available approved treatments for DME.

Trial locations

0 location(s)