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NCT06662994
High Dose Aflibercept in Diabetic Macular Edema in Patients With Previous Vitrectomy
Phase 4 trial testing Aflibercept 8 mg (VEGF Trap-Eye, BAY86-5321) in Diabetic Macular Edema (DME) in 15 participants. Currently enrolling.
15 August 2026
Quick facts
| Lead sponsor | Retina Consultants of Orange County |
|---|---|
| Phase | Phase 4 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 15 |
| Start date | 7 July 2025 |
| Primary completion | 15 August 2026 |
| Estimated completion | 15 August 2027 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Aflibercept 8 mg (VEGF Trap-Eye, BAY86-5321) — full drug profile →
Conditions studied
- Diabetic Macular Edema (DME) — all drugs for Diabetic Macular Edema (DME) →
Sponsor
Retina Consultants of Orange County — full company profile →
Who can join
21 and older, any sex, with Diabetic Macular Edema (DME). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Related trials
Other trials of Aflibercept 8 mg (VEGF Trap-Eye, BAY86-5321)
Trials testing the same drug.
- NCT06075147 — The SPECTRUM Study: An Observational Study to Learn More About How Well Aflibercept 8 mg Works in Treating Visual Impair · active not recruiting
Other recruiting trials for Diabetic Macular Edema (DME)
Currently open trials in the same condition.
- NCT07520045 — Biomarkers in Diabetic Retinopathy Treated With Faricimab vs Biosimilar Ranibizumab · NA · recruiting
- NCT06957080 — A Study of 2 Doses of EYE103 Compared With Ranibizumab (0.5 mg) in Participants With DME · Phase 2, PHASE3 · active not recruiting
- NCT06929143 — A Study to Learn More About the Use of Aflibercept in Routine Medical Practice in Japanese Participants With Neovascular · active not recruiting
- NCT06914778 — Investigating the Metabolic and Lipidomic Profiles That Are Associated With Varying Grades of Diabetic Maculopathy and R · recruiting
- NCT06929507 — Impact of Intravitreal Faricimab on Renal Function in Diabetic Patients · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06662994 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Retina Consultants of Orange County
- Last refreshed: 10 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06662994.
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