A Study to Evaluate the Efficacy and Safety of KSI-301, an Anti-VEGF Antibody Biopolymer Conjugate, Versus Aflibercept in Patients With Neovascular (Wet) Age-Related Macular Degeneration.
Public ClinicalTrials.gov record NCT04049266. 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 Phase 2b/3, Prospective, Randomized, Double-masked, Active Comparator-controlled, Multi-center Study to Investigate the Efficacy and Safety of Repeated Intravitreal Administration of KSI-301 in Subjects With Neovascular (Wet) Age-related Macular Degeneration.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study will evaluate the efficacy, safety, durability, and pharmacokinetics of KSI-301 administered at 12, 16 and 20 weeks intervals as specified in the protocol, compared with aflibercept once every 8 weeks (Q8W), in participants with treatment-naïve neovascular (wet) age-related macular degeneration (nAMD).
Study identification
- NCT ID
- NCT04049266
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 559 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 50 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
- Oct 8, 2019 (Actual)
- Primary completion
- Nov 17, 2021 (Actual)
- Completion
- Apr 26, 2022 (Actual)
- Last update posted
- Jul 18, 2024
2019 – 2022
United States locations
- U.S. sites
- 59
- U.S. states
- 23
- U.S. cities
- 56
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Retinal Research Institute, LLC | Phoenix | Arizona | 85014 | — |
| Northwest Arkansas Retina Associates | Springdale | Arkansas | 72762 | — |
| California Retina Consultants | Bakersfield | California | 93309 | — |
| Retina Vitreous Associates | Beverly Hills | California | 90211 | — |
| Eye Medical Center of Fresno | Fresno | California | 93720 | — |
| Retina Consultants of Orange County | Fullerton | California | 92835 | — |
| UCSD Jacobs Retina Center | La Jolla | California | 92037 | — |
| Retina Associates of Orange County | Laguna Hills | California | 92653 | — |
| Northern California Retina Vitreous Associates | Mountain View | California | 94040 | — |
| Retina Consultants of San Diego | Poway | California | 92064 | — |
| Retinal Consultants Medical Group Inc | Sacramento | California | 95819 | — |
| Orange County Retina Medical Group | Santa Ana | California | 92705 | — |
| California Retina Consultants | Santa Maria | California | 93454 | — |
| Colorado Retina Associates PC | Lakewood | Colorado | 80228 | — |
| Florida Eye Microsurgical Institute | Boynton Beach | Florida | 33426 | — |
| Rand Eye Institute | Deerfield Beach | Florida | 33064 | — |
| Retina Health Center | Fort Myers | Florida | 33907 | — |
| National Ophthalmic Research Institute | Fort Myers | Florida | 33912 | — |
| Florida Eye Associates | Melbourne | Florida | 32901 | — |
| Retina Specialty Institute | Pensacola | Florida | 32503 | — |
| Retina Vitreous Associates of Florida | St. Petersburg | Florida | 33703 | — |
| Retina Associates of Florida | Tampa | Florida | 33609 | — |
| Southeast Retina Center | Augusta | Georgia | 30909 | — |
| Wolfe Eye Clinic | West Des Moines | Iowa | 50266 | — |
| Retina Associates PA | Lenexa | Kansas | 66215 | — |
| Vitreo Retinal Consultants and Surgeons | Wichita | Kansas | 67214 | — |
| Retina Associates of Kentucky | Lexington | Kentucky | 40509 | — |
| Cumberland Valley Retina Consultants PC | Hagerstown | Maryland | 21740 | — |
| New England Retina Consultants | Springfield | Massachusetts | 01103 | — |
| Vitreo Retinal Associates PC | Worcester | Massachusetts | 01603 | — |
| Foundation for Vision Research | Grand Rapids | Michigan | 49525 | — |
| Associated Retinal Consultants PC | Royal Oak | Michigan | 78073 | — |
| Vitreoretinal Surgery PA | Edina | Minnesota | 55435 | — |
| Springfield Clinic LLP | Springfield | Missouri | 62703 | — |
| Sierra Eye Associates | Reno | Nevada | 89502 | — |
| The Retina Center of New Jersey | Bloomfield | New Jersey | 07017 | — |
| NJ Retina | Teaneck | New Jersey | 07605 | — |
| Retina Associates of Cleveland | Beachwood | Ohio | 44122 | — |
| Retina Associates of Cleveland | Cleveland | Ohio | 44130 | — |
| Cleveland Clinic Foundation, Cole Eye Institute | Cleveland | Ohio | 44195 | — |
| Retina and Vitreous Center of Southern Oregon PC | Ashland | Oregon | 97520 | — |
| Cascade Medical Research Institute | Eugene | Oregon | 97401 | — |
| Retina Northwest | Portland | Oregon | 97210 | — |
| Wills Eye Hospital | Philadelphia | Pennsylvania | 19107 | — |
| Palmetto Retina Center | Florence | South Carolina | 29501 | — |
| Charleston Neuroscience Institute | Ladson | South Carolina | 29456 | — |
| Black Hills Regional Eye Institute | Rapid City | South Dakota | 57701 | — |
| Southeastern Retina Associates PC | Knoxville | Tennessee | 37909 | — |
| Tennessee Retina PC | Nashville | Tennessee | 37203 | — |
| Retina Research Institute of Texas | Abilene | Texas | 79606 | — |
| Austin Clinical Research, LLC | Austin | Texas | 78705 | — |
| Austin Retina Associates | Austin | Texas | 78705 | — |
| Retina Consultants of Texas | Bellaire | Texas | 77401 | — |
| Retina Consultants of Texas (Katy) | Katy | Texas | 77494 | — |
| Texas Retina Associates | Plano | Texas | 75075 | — |
| Austin Retina Associates (Round Rock) | Round Rock | Texas | 78681 | — |
| Medical Center Ophthalmology Associates | San Antonio | Texas | 78240 | — |
| Retina Consultants of Texas (Woodlands) | The Woodlands | Texas | 77384 | — |
| Strategic Clinical Research Group, LLC | Willow Park | Texas | 76087 | — |
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 16 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04049266, 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 Jul 18, 2024 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04049266 live on ClinicalTrials.gov.