Actively Recruiting
High Dose Aflibercept in Diabetic Macular Edema in Patients With Previous Vitrectomy
Led by Retina Consultants of Orange County · Updated on 2025-07-10
15
Participants Needed
1
Research Sites
109 weeks
Total Duration
On this page
Sponsors
R
Retina Consultants of Orange County
Lead Sponsor
R
Regeneron Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
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. Those patients still require intravitreal injections but the pharmacokinetics of a vitrectomized eye are different than those eyes that have not undergone vitrectomy. The clearance of protein molecules is quicker in vitrectomized eyes so these patients may be more refractory to standard of care anti-VEGF therapy. In rabbit models, the half-life of both bevacizumab and ranibizumab were reduced by a factor 1.8 and 1.3, respectively, after pars plana vitrectomy. In a study examining intravitreal triamcinolone acetonide in human eyes, the half-life was found to be 18.6 days in non-vitrectomized eyes and 3.2 days in vitrectomized eyes, but there was considerable intrasubject variation. Patients with various disease states, including neovascular age-related macular degeneration (nAMD) have been managed with monthly anti-VEGF therapy successfully after vitrectomy surgery. Another study performed by the DRCR net showed that patients with DME treated with anti-VEGF are not affected in the long term if they had had a previous vitrectomy. High dose aflibercept may improve anatomic and visual outcomes in this patient population. Also, high dose aflibercept may allow for longer treatment intervals in these vitrectomized eyes.
CONDITIONS
Official Title
High Dose Aflibercept in Diabetic Macular Edema in Patients With Previous Vitrectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men or women 18 years of age or older with type 1 or type 2 diabetes mellitus
- Diabetic macular edema with central involvement and central retinal thickness of 320 micrometers or more in the study eye
- Best corrected visual acuity between 84 and 20 ETDRS letters (approximate Snellen equivalent 20/25 to 20/400) in the study eye with vision loss primarily due to diabetic macular edema
- Willing and able to comply with clinic visits and study procedures
- Provide informed consent signed by patient or legally acceptable representative
- Previous history of vitrectomy surgery
You will not qualify if you...
- Macular edema caused by conditions other than diabetes mellitus in either eye
- Prior use of intravitreal investigational agents in the study eye
- Intraocular pressure of 28 mmHg or higher in the study eye
- History of glaucoma filtration surgery
- Infectious eye conditions such as blepharitis, keratitis, scleritis, or conjunctivitis within 4 weeks before screening
- Any intraocular inflammation or infection within 6 weeks before screening
- History of idiopathic or autoimmune uveitis in the study eye
- Vitreomacular traction or epiretinal membrane affecting central vision in the study eye
- Iris neovascularization, vitreous hemorrhage, or tractional retinal detachment visible at screening in the study eye
- History of corneal transplant or corneal dystrophy in the study eye
- Any ocular condition that increases risk or interferes with injection or evaluation
- Structural damage to the center of the macula likely preventing vision improvement after edema resolution
- Inability to obtain necessary eye photographs or imaging due to media opacity, allergy, or lack of venous access
- Other diseases, metabolic dysfunctions, or clinical findings contraindicating high dose aflibercept or affecting study results
- Uncontrolled diabetes with hemoglobin A1c greater than 14%
- History of stroke or heart attack within 24 weeks before screening
- Known sensitivity to any study drug components
- Participation in another investigational study involving drugs or devices within 30 days before screening
- Pregnant or breastfeeding women
- Women of childbearing potential unwilling to use highly effective contraception before and during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Retina Consultants of Orange County
Fullerton, California, United States, 92835
Actively Recruiting
Research Team
S
Sean Adrean, M.D.
CONTACT
A
Andrew Yates, B.A.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here