High-dose aflibercept for diabetic macular edema after vitrectomy
High Dose Aflibercept in Diabetic Macular Edema in Patients With Previous Vitrectomy
We will try a higher dose of aflibercept (8 mg) to see if it better controls diabetic macular edema in people who have had vitrectomy.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Retina Consultants of Orange County Academic / other |
| Drugs / interventions | ranibizumab, bevacizumab |
| Locations | 1 site (Fullerton, California) |
| Trial ID | NCT06662994 on ClinicalTrials.gov |
What this trial studies
This Phase 4 interventional study treats eyes with prior pars plana vitrectomy and center-involving diabetic macular edema using intravitreal aflibercept 8 mg following a treat-extend-stop (TES) protocol. Patients receive three loading injections at 4–6 week intervals, then intervals are extended by 1–2 weeks up to 12 weeks if the macula is dry on OCT, or shortened if fluid or vision worsens. The protocol is designed to address faster drug clearance observed in vitrectomized eyes by using a higher dose and individualized interval adjustments based on OCT and visual acuity. Outcomes include anatomical response on OCT (central retinal thickness) and visual acuity over the treatment period.
Who should consider this trial
Good fit: Adults (≥18) with type 1 or 2 diabetes who have center-involving DME (CRT ≥320 μm), prior vitrectomy in the study eye, and visual acuity approximately 20/25 to 20/400 largely due to DME are ideal candidates.
Not a fit: Patients without prior vitrectomy, those whose macular edema is from other causes, or whose vision loss is not primarily due to DME are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could give better, longer-lasting control of macular swelling and reduce how often patients need injections, helping stabilize vision.
How similar studies have performed: Other anti-VEGF agents like ranibizumab and bevacizumab have shown some anatomic benefit after vitrectomy, but using high-dose aflibercept specifically in vitrectomized DME eyes is relatively novel and not extensively studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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: 1. Men or women ≥18 years of age with type 1 or type 2 diabetes mellitus 2. DME with central involvement in the study eye with CRT ≥320 μm on Spectralis. 3. 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 4. Willing and able to comply with clinic visits and study-related procedures 5. Provide informed consent signed by study patient or legally acceptable representative 6. Have a previous history of vitrectomy surgery. Exclusion Criteria: * A patient who meets any of the following criteria at either the screening or randomization visits will be excluded from the study: 1. Evidence of macular edema due to any cause other than diabetes mellitus in either eye 2. Prior intravitreal investigational agents in the study eye (gene therapy, etc.) at any time 3. IOP ≥28 mmHg in the study eye 4. History of glaucoma filtration surgery in the past 5. Evidence of infectious blepharitis, keratitis, scleritis , or conjunctivitis in either eye within 4 weeks (28 days) of the screening visit. 6. Any intraocular inflammation/infection in either eye within 6 weeks (42 days) of the screening visit. 7. History of idiopathic or autoimmune uveitis in the study eye 8. Vitreomacular traction or epiretinal membrane in the study eye evident on biomicroscopy or OCT that is thought to affect central vision 9. Current iris neovascularization, vitreous hemorrhage, or tractional retinal detachment visible at the screening assessments in the study eye 10. History of corneal transplant or corneal dystrophy in study eye 11. 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 which otherwise may interfere with the injection procedure or with evaluation of efficacy or safety. 12. 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 fibrosis or scar, significant macular ischemia, or organized hard exudates 13. 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 14. 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 or that might affect interpretation of the results of the study or render the patient at high risk for treatment complications 15. Uncontrolled diabetes mellitus as defined by hemoglobin A1c (HbA1c) \> 14% 16. History of cerebrovascular accident or myocardial infarction within 24 weeks (168 days) of screening visit 17. Known sensitivity to any of the compounds of the study formulation 18. Participation in an investigational study within 30 days prior to screening visit that involved treatment with any drug (excluding vitamins and minerals) or device 19. Pregnant or breastfeeding women 20. 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.
Where this trial is running
Fullerton, California
- Retina Consultants of Orange County — Fullerton, California, United States (Recruiting)
Study contacts
- Principal investigator: Sean Adrean, M.D. — Retina Consultants of Orange County
- Study coordinator: Sean Adrean, M.D.
- Email: seadrean@yahoo.com
- Phone: 714-738-4620
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.