Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06662994 · ClinicalTrials.gov registry record · Phase 4
High Dose Aflibercept in Diabetic Macular Edema in Patients With Previous Vitrectomy
A Phase 4 study of Diabetic Macular Edema (DME), sponsored by Retina Consultants of Orange County.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT06662994: Recruiting Phase 4 study of Diabetic Macular Edema (DME), sponsored by Retina Consultants of Orange County.
NCT06662994 is a Phase 4 study of Diabetic Macular Edema (DME) that is actively recruiting participants, run by Retina Consultants of Orange County. The registered enrollment target is 15 participants, below the 360-participant average among 8 other Diabetic Macular Edema (DME) trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06662994, a Phase 4 study of Diabetic Macular Edema (DME), is actively recruiting participants, sponsored by Retina Consultants of Orange County.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Visual Acuity will be measured at each visit.
Conditions Studied
Interventions
- DRUG Aflibercept 8 mg (VEGF Trap-Eye, BAY86-5321)
Study Locations (1)
California
- Retina Consultants of Orange County - Fullerton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2025-07-07 |
| Est. Completion | 2027-08-15 |
| Phase | Phase 4 |
What NCT06662994 shows while recruiting
NCT06662994 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 360-participant average among 8 other Diabetic Macular Edema (DME) trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Diabetic Macular Edema (DME) appearing as the primary indexed condition, and to 1 intervention - of which Aflibercept 8 mg (VEGF Trap-Eye, BAY86-5321) is the first listed.
NCT06662994 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT06662994 about?
NCT06662994 is a clinical study titled "High Dose Aflibercept in Diabetic Macular Edema in Patients With Previous Vitrectomy". 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 vit...
What is the current status of trial NCT06662994?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 15 participants. The study started on 2025-07-07. Estimated completion is 2027-08-15.
What conditions does trial NCT06662994 study?
This clinical trial studies the following conditions: Diabetic Macular Edema (DME).
What interventions are being tested in trial NCT06662994?
The interventions under investigation include: Aflibercept 8 mg (VEGF Trap-Eye, BAY86-5321) (DRUG).
Who is sponsoring clinical trial NCT06662994?
This trial is sponsored by Retina Consultants of Orange County, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06662994 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetic Macular Edema (DME)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06662994's enrollment target sits among peer trials
15 8th of 8 higher than 1 of 8 other Diabetic Macular Edema (DME) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetic Macular Edema (DME) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
CAPRI: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
RECRUITING · Phase 3
-
COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
RECRUITING · Phase 3
-
A Study of Avoralstat In Participants With Diabetic Macular Edema
RECRUITING · Phase 1
-
Study to Assess the Efficacy & Safety of KHK4951 in Patients With Diabetic Macular Edema
ACTIVE NOT RECRUITING · Phase 2
-
A 2-part Study Consisting of a Multiple Ascending Dose Safety Study in Participants With Macular Edema Following Branch Retinal Vein Occlusion and a Dose-finding Safety and Preliminary Efficacy Study in Participants With Either Diabetic Macular Edema or Neovascular Age-related Macular Degeneration
ACTIVE NOT RECRUITING · Phase 1
-
A Study of 2 Doses of EYE103 Compared With Ranibizumab (0.5 mg) in Participants With DME
ACTIVE NOT RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01889381 · 15 participants · Phase 2
Human Craniomaxillofacial Allotransplantation
- NCT02530073 · 15 participants · NA
Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) for CDH
- NCT02535936 · 15 participants · NA
Cortical Plasticity in Spastic Diplegia After Selective Dorsal Rhizotomy
- NCT02918474 · 15 participants · NA
Decision Making Tool in Supporting Decision Making in Contralateral Prophylactic Mastectomy in Patients With Newly Diagnosed Breast Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI