Aflibercept for Diabetic Macular Edema

Recruiting in Palo Alto (17 mi)

Overseen bySean Adrean, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Retina Consultants of Orange County

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

Sean Adrean, M.D.

Principal Investigator

Retina Consultants of Orange County

Eligibility Criteria

This trial is for patients with diabetic macular edema who have had a vitrectomy surgery. It's designed to see if high doses of Aflibercept can better improve their condition, considering the faster clearance of medication from eyes that have undergone this procedure.

Inclusion Criteria

I am 18 or older with type 1 or type 2 diabetes.

Willing and able to comply with clinic visits and study-related procedures

Provide informed consent signed by study patient or legally acceptable representative

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Exclusion Criteria

I have swelling in the retina not caused by diabetes.

Prior intravitreal investigational agents in the study eye (gene therapy, etc.) at any time

IOP ≥28 mmHg in the study eye

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Treatment Details

Interventions

Aflibercept (Monoclonal Antibodies)

Trial OverviewThe study tests whether a higher dose (8 mg) of Aflibercept, an anti-VEGF therapy, can provide better outcomes for those with diabetic macular edema after vitrectomy surgery compared to standard treatments.

Participant Groups

1Treatment groups

Active Control

Group I: Patients with previous vitrectomy and diabetic macular edema treated with high dose afliberceptActive Control1 Intervention

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.