RecruitingPhase 4NCT06662994

High Dose Aflibercept in Diabetic Macular Edema in Patients With Previous Vitrectomy


Sponsor

Retina Consultants of Orange County

Enrollment

15 participants

Start Date

Jul 7, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a high-dose version of a drug called aflibercept — injected directly into the eye — for treating diabetic macular edema (swelling in the central part of the retina caused by diabetes) in patients who have previously had vitreous surgery (a procedure that removes the gel inside the eye). **You may be eligible if...** - You are 18 or older and have type 1 or type 2 diabetes - You have diabetic macular edema with significant swelling in the central retina (measured by a specific scan) - Your vision in the affected eye is between 20/25 and 20/400 - Your reduced vision is mainly caused by the diabetic swelling - You have had a vitrectomy (eye surgery removing the gel) in the past **You may NOT be eligible if...** - Your macular swelling is caused by something other than diabetes - You have previously received experimental injections into your eye (gene therapy, etc.) - You have high eye pressure (above 28 mmHg) or a history of glaucoma drainage surgery - You have an active eye infection or inflammation - You have a history of certain immune or inflammatory eye conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAflibercept 8 mg (VEGF Trap-Eye, BAY86-5321)

Identify patients that have had a previous vitrectomy and have DME that requires anti-VEGF therapy. Then using a treat-extend-stop protocol6,7 that I previously published, treat patients with DME using high dose aflibercept, until the fluid has resolved and then extend the time interval in between treatments for those patients, while maintaining a fluid-free macula.


Locations(1)

Retina Consultants of Orange County

Fullerton, California, United States

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NCT06662994


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