High Dose Eylea for Proliferative Diabetic Retinopathy Outcomes

Launched by EDWARD WOOD, MD · Aug 7, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a higher dose of a medicine called Eylea (aflibercept) to see if it is safe for people with a specific eye condition called proliferative diabetic retinopathy (PDR). PDR is a serious complication of diabetes that affects the blood vessels in the eye and can lead to vision loss. This study focuses on patients who have PDR but do not have swelling in the center of the retina, which is important for clear vision. The goal is to better understand if this higher dose of Eylea can be safely used in these patients.

To join this study, participants need to be adults with type 1 or type 2 diabetes who have been diagnosed with PDR in one eye. They should be able to attend regular clinic visits and agree to all study procedures. People who have had certain treatments or eye surgeries recently, or who have other eye problems or infections, may not be eligible. During the study, participants will receive the higher dose of Eylea and have their eye health closely monitored to check for any side effects. If you or a loved one fits these criteria and are interested, this trial could offer a chance to help improve treatment for diabetic eye disease.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Willing and able to comply with clinic visits and study-related procedures
• • Provide signed informed consent
• • Men or women \> 18 years of age at the time of signing the Informed Consent Form
• • Diagnosed with type 1 or type 2 diabetes mellitus
• • BCVA ETDRS \>/= 20/400 in the study eye
• • Proliferative Diabetic Retinopathy as diagnosed via clinical examination and fluorescein angiography
• Exclusion Criteria:
• • Any known hypersensitivity to any of the components of aflibercept 8 mg injection
• • Any known hypersensitivity to any contrast media (e.g., fluorescein), dilating eye drops, disinfectants (e.g., iodine), or any of the anesthetics and antimicrobial preparations used bye the site during the study
• • Prior systemic anti-VEGF or IVT anti-VEGF treatment in the study eye within 3 months of enrollment. (i.e., 3-month wash-out period for anti-VEGF allowed)
• • Any intra- or periocular corticosteroid treatment in the study eye within 3 months of baseline
• • Any intraocular sustained-release treatment or implantable device
• • Any gene therapy in the study eye
• • SD-OCT central subfield thickness measurement of \> 320 µm, in the study eye
• • Evidence of ocular infection, in the study eye, at time of screening
• • IOP \> 25 mmHg in the study eye
• • Any intraocular inflammation/ infection in either eye within 12 weeks (84 days) of the screening visit
• • History of vitreoretinal surgery in the study eye
• • Any prior Panretinal laser photocoagulation (PRP) in the study eye
• • Current vitreous hemorrhage obscuring clear view of the macula in the study eye
• • Presence of tractional retinal detachment and/or pre-retinal fibrosis causing retinal elevation/ thickening
• • Cataract surgery in the study eye within 4 weeks prior to Screening/ Day 0
• • Blood pressure \> 180/100 mmHg systolic/ diastolic, while seated
• • Pregnant or breastfeeding women
• • Sexually active men\* or women of childbearing potential\*\* who are unwilling to practice adequate contraception during the study (adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening/ baseline; intrauterine device \[IUD\]; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly).
• • Contraception is not required for men with documented vasectomy
• • Postmenopausal women must be amenorrhoeic for at least 12 months in order not to be considered of childbearing potential. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.