High Dose Eylea for Proliferative Diabetic Retinopathy Outcomes (NCT07118670) | Clinical Trial Compass
Active — Not RecruitingPhase 4
High Dose Eylea for Proliferative Diabetic Retinopathy Outcomes
United States40 participantsStarted 2025-12-08
Plain-language summary
The purpose of this Phase 4 study is to evaluate the safety of aflibercept 8mg in patients with proliferative diabetic retinopathy without center-involved diabetic macular edema.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* Any 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 (90 days) wash-out period for anti-VEGF allowed)
* Any intra- or periocular corticosteroid treatment in the study eye within 3 months (90 days) of baseline
* Any intraocular sustained-release treatment or implantable device in the study eye
* 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 lase…