High Dose Aflibercept in Diabetic Macular Edema in Patients With Previous Vitrectomy
Retina Consultants of Orange County
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.
Description
Patients with Diabetic Macular Edema (DME) and previous Pars Plana Vitrectomy (PPV) will be treated with a treat-extend-stop (TES) protocol that was previously published. Below is the description of the TES protocol published in the International Journal of Retina and Vitreous. This protocol was originally used in patients with neovascular age-related macular degeneration (nAMD) but it is being adapted for treatment of patients with DME in this study. Patients were treated following the treat-and-extend-stop (TES) protocol, which is a variant to the treat-and-extend regimen. The TES treatment…
Eligibility
- Age range
- 21+ years
- Sex
- All
- Healthy volunteers
- No
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 c…
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.
Location
- Retina Consultants of Orange CountyFullerton, California