Study of a High-Dose Aflibercept in Participants With Diabetic Eye Disease
Public ClinicalTrials.gov record NCT04429503. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-Masked, Active-Controlled Phase 2/3 Study of the Efficacy and Safety of High-Dose Aflibercept in Patients With Diabetic Macular Edema
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objective of the study is to determine if treatment with high-dose aflibercept (HD) at intervals of 12 or 16 weeks provides non-inferior best corrected visual acuity (BCVA) compared to aflibercept dosed every 8 weeks. The secondary objectives of the study are as follows: * To determine the effect of HD vs. aflibercept on anatomic and other visual measures of response * To evaluate the safety, immunogenicity, and pharmacokinetics (PK) of aflibercept
Study identification
- NCT ID
- NCT04429503
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 660 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 29, 2020 (Actual)
- Primary completion
- May 30, 2022 (Actual)
- Completion
- Jun 18, 2024 (Actual)
- Last update posted
- Aug 8, 2025
2020 – 2024
United States locations
- U.S. sites
- 84
- U.S. states
- 29
- U.S. cities
- 81
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Regeneron Study Site | Phoenix | Arizona | 85021 | — |
| Regeneron Study Site | Arcadia | California | 91006 | — |
| Regeneron Study Site | Beverly Hills | California | 90211 | — |
| Regeneron Study Site | Campbell | California | 95008 | — |
| Regeneron Study Site | Encino | California | 91436 | — |
| Regeneron Study Site | Fullerton | California | 92835 | — |
| Regeneron Study Site | Huntington Beach | California | 92647 | — |
| Regeneron Study Site | Long Beach | California | 90807 | — |
| Regeneron Study Site | Palo Alto | California | 94303 | — |
| Regeneron Study Site | Pasadena | California | 91107 | — |
| Regeneron Study Site | Poway | California | 92064 | — |
| Regeneron Study Site | Rancho Cordova | California | 95670 | — |
| Regeneron Study Site | Riverside | California | 92505 | — |
| Regeneron Study Site | Torrance | California | 90509 | — |
| Regeneron Study Site | Colorado Springs | Colorado | 80909 | — |
| Regeneron Study Site | Durango | Colorado | 81301 | — |
| Regeneron Study Site | Lakewood | Colorado | 80228 | — |
| Regeneron Study Site | Waterford | Connecticut | 06385 | — |
| Regeneron Study Site | Clearwater | Florida | 33761 | — |
| Regeneron Study Site | Fort Lauderdale | Florida | 33308 | — |
| Regeneron Study Site | Fort Myers | Florida | 33912 | — |
| Regeneron Study Site | Jacksonville | Florida | 32216 | — |
| Regeneron Study Site | Lakeland | Florida | 33805 | — |
| Regeneron Study Site | Largo | Florida | 33770 | — |
| Regeneron Study Site | Melbourne | Florida | 32901 | — |
| Regeneron Study Site | Miami | Florida | 33126 | — |
| Regeneron Study Site | Orlando | Florida | 32806 | — |
| Regeneron Study Site | Pinellas Park | Florida | 33782 | — |
| Regeneron Study Site | Plantation | Florida | 33324 | — |
| Regeneron Study Site | St. Petersburg | Florida | 33711 | — |
| Regeneron Study Site | Stuart | Florida | 34994 | — |
| Regeneron Study Site | Winter Haven | Florida | 33880 | — |
| Regeneron Study Site | Augusta | Georgia | 30909 | — |
| Regeneron Study Site 1 | Marietta | Georgia | 30060 | — |
| Regeneron Study Site 2 | Marietta | Georgia | 30060 | — |
| Regeneron Study Site | ‘Aiea | Hawaii | 96701 | — |
| Regeneron Study Site | Oak Forest | Illinois | 60452 | — |
| Regeneron Study Site | Springfield | Illinois | 62703 | — |
| Regeneron Study Site | Springfield | Illinois | 62704 | — |
| Regeneron Study Site | Carmel | Indiana | 46290 | — |
| Regeneron Study Site | Shawnee Mission | Kansas | 66204 | — |
| Regeneron Study Site | Baltimore | Maryland | 21209 | — |
| Regeneron Study Site | Hagerstown | Maryland | 21740 | — |
| Regeneron Study Site | Boston | Massachusetts | 02114 | — |
| Regeneron Study Site | Royal Oak | Michigan | 48073 | — |
| Regeneron Study Site | Southaven | Mississippi | 38671 | — |
| Regeneron Study Site | Henderson | Nevada | 89052 | — |
| Regeneron Study Site | Bloomfield | New Jersey | 07003 | — |
| Regeneron Study Site | Edison | New Jersey | 08820 | — |
| Regeneron Study Site | Teaneck | New Jersey | 07666 | — |
| Regeneron Study Site | Great Neck | New York | 11021 | — |
| Regeneron Study Site | Liverpool | New York | 13088 | — |
| Regeneron Study Site | New York | New York | 11221 | — |
| Regeneron Study Site | Oceanside | New York | 11572 | — |
| Regeneron Study Site | Shirley | New York | 02114 | — |
| Regeneron Study Site | Asheville | North Carolina | 28803 | — |
| Regeneron Study Site | Charlotte | North Carolina | 28210 | — |
| Regeneron Study Site | Beachwood | Ohio | 44122 | — |
| Regeneron Study Site | Cincinnati | Ohio | 45202 | — |
| Regeneron Study Site | Cincinnati | Ohio | 45242 | — |
| Regeneron Study Site | Cleveland | Ohio | 44130 | — |
| Regeneron Study Site | Dublin | Ohio | 43016 | — |
| Regeneron Study Site | Edmond | Oklahoma | 73013 | — |
| Regeneron Study Site | Tulsa | Oklahoma | 74114 | — |
| Regeneron Study Site | Portland | Oregon | 97225 | — |
| Regeneron Study Site | Bethlehem | Pennsylvania | 18017 | — |
| Regeneron Study Site | Kingston | Pennsylvania | 18704 | — |
| Regeneron Study Site | Monroeville | Pennsylvania | 15146 | — |
| Regeneron Study Site | Beaufort | South Carolina | 29902 | — |
| Regeneron Study Site | Ladson | South Carolina | 29456 | — |
| Regeneron Study Site | West Columbia | South Carolina | 29169 | — |
| Regeneron Study Site | Rapid City | South Dakota | 57701 | — |
| Regeneron Study Site | Germantown | Tennessee | 38138 | — |
| Regeneron Study Site | Knoxville | Tennessee | 37922 | — |
| Regeneron Study Site | Nashville | Tennessee | 37203 | — |
| Regeneron Study Site | Abilene | Texas | 79606 | — |
| Regeneron Study Site | Bellaire | Texas | 77401 | — |
| Regeneron Study Site 2 | San Antonio | Texas | 78240 | — |
| Regeneron Study Site | The Woodlands | Texas | 77384 | — |
| Regeneron Study Site | Willow Park | Texas | 76087 | — |
| Regeneron Study Site 1 | Salt Lake City | Utah | 84107 | — |
| Regeneron Study Site | Fairfax | Virginia | 22031 | — |
| Regeneron Study Site | Norfolk | Virginia | 23502 | — |
| Regeneron Study Site | Morgantown | West Virginia | 26506 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 54 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04429503, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 8, 2025 · Synced Oct 19, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04429503 live on ClinicalTrials.gov.