Diabetic Macular Edema study: Aflibercept
Official title High Dose Aflibercept in Diabetic Macular Edema in Patients With Previous Vitrectomy
ClinicalTrials.gov ID: NCT06662994
What this study is testing
What is Aflibercept 8 mg (VEGF Trap‑Eye, BAY86-5321)?
An investigational intravitreal injection being studied for diabetic macular edema in patients who have had a vitrectomy. It is designed to bind vascular endothelial growth factor (VEGF) and reduce abnormal blood vessel growth and leakage.
Also referred to as Aflibercept.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see if a higher dose of aflibercept can improve eye thickness and vision in patients whose eyes have been operated on, and if it allows longer gaps between injections.
- Who it's for
- Adults with diabetic macular edema who previously had vitrectomy surgery.
- What's involved
- Participants will receive intravitreal (inside the eye) injections of high‑dose aflibercept and will have eye exams and imaging tests during the study.
- Time commitment
- The study lasts several months, with scheduled visits for injections and eye examinations at each visit.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 and older
You may be able to join if
- Men or women ≥18 years of age with type 1 or type 2 diabetes mellitus
- DME with central involvement in the study eye with CRT ≥320 μm on Spectralis.
- BCVA early treatment diabetic retinopathy study (ETDRS) letter score of 84 to 20 (approximate Snellen equivalent of 20/25 to 20/400) in the study eye...
- Willing and able to comply with clinic visits and study-related procedures
- Provide informed consent signed by study patient or legally acceptable representative
You likely can't join if
- Evidence of macular edema due to any cause other than diabetes mellitus in either eye
- Prior intravitreal investigational agents in the study eye (gene therapy, etc.) at any time
- IOP ≥28 mmHg in the study eye
- History of glaucoma filtration surgery in the past
- Evidence of infectious blepharitis, keratitis, scleritis , or conjunctivitis in either eye within 4 weeks (28 days) of the screening visit.
- Any intraocular inflammation/infection in either eye within 6 weeks (42 days) of the screening visit.
See the full eligibility criteria
- Men or women ≥18 years of age with type 1 or type 2 diabetes mellitus
- DME with central involvement in the study eye with CRT ≥320 μm on Spectralis.
- BCVA early treatment diabetic retinopathy study (ETDRS) letter score of 84 to 20 (approximate Snellen equivalent of 20/25 to 20/400) in the study eye with decreased vision determined to be primarily the result of DME
- Willing and able to comply with clinic visits and study-related procedures
- Provide informed consent signed by study patient or legally acceptable representative
- Have a previous history of vitrectomy surgery.
- Evidence of macular edema due to any cause other than diabetes mellitus in either eye
- Prior intravitreal investigational agents in the study eye (gene therapy, etc.) at any time
- IOP ≥28 mmHg in the study eye
- History of glaucoma filtration surgery in the past
- Evidence of infectious blepharitis, keratitis, scleritis , or conjunctivitis in either eye within 4 weeks (28 days) of the screening visit.
- Any intraocular inflammation/infection in either eye within 6 weeks (42 days) of the screening visit.
- History of idiopathic or autoimmune uveitis in the study eye
- Vitreomacular traction or epiretinal membrane in the study eye evident on biomicroscopy or OCT that is thought to affect central vision
- Current iris neovascularization, vitreous hemorrhage, or tractional retinal detachment visible at the screening assessments in the study eye
- History of corneal transplant or corneal dystrophy in study eye
- Any concurrent ocular condition in the study eye which, in the opinion of the investigator, could either increase the risk to the patient beyond what is to be expected from standard procedures of IVT injections, or...
- Structural damage to the center of the macula in the study eye that is likely to preclude improvement in BCVA following the resolution of macular edema including atrophy of the retinal pigment epithelium, subretinal...
- Inability to obtain photographs, FA, or SD-OCT in the study eye, eg, due to media opacity, allergy to fluorescein dye, or lack of venous access
- History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of high dose aflibercept...
- Uncontrolled diabetes mellitus as defined by hemoglobin A1c (HbA1c) \> 14%
- History of cerebrovascular accident or myocardial infarction within 24 weeks (168 days) of screening visit
- Known sensitivity to any of the compounds of the study formulation
- Participation in an investigational study within 30 days prior to screening visit that involved treatment with any drug (excluding vitamins and minerals) or device
- Pregnant or breastfeeding women
- Men or women of childbearing potential (WOCBP)\ who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment and during the study.
The study team makes the final eligibility decision.
Where it is enrolling
- Fullerton, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Fullerton, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.