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New treatment option for Diabetic Macular Edema (DME)
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)?
Aflibercept 8 mg (VEGF Trap-Eye, BAY86-5321) is an investigational medicine, given as a monthly infusion into a vein, being studied as a potential treatment for diabetic macular edema (dme).
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
- Patients with diabetic macular edema (DME) sometimes must undergo vitrectomy surgery (PPV) for diabetic and non-diabetic related issues. Patients may have improved DME with anti-VEGF therapy and ranibizumab has been found to reduce central macular thickness (CMT) with anti-VEGF therapy following vitrectomy.
- 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
- A patient must meet the following criteria at both the screening and randomization visits (except where indicated) to be eligible for inclusion in...
- 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
You likely can't join if
- A patient who meets any of the following criteria at either the screening or randomization visits will be excluded from the study:
- 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.
See the full eligibility criteria
- A patient must meet the following criteria at both the screening and randomization visits (except where indicated) to be eligible for inclusion in the study:
- 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.
- A patient who meets any of the following criteria at either the screening or randomization visits will be excluded from the study:
- 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's taking place
- 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 - 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?
Study sites include Fullerton, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.