Study to Assess the Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Compared to Laser Photocoagulation in Patients With Retinopathy of Prematurity
Public ClinicalTrials.gov record NCT04101721. 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
Randomized, Controlled, Multi-Center Study to Assess the Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Compared to Laser Photocoagulation in Patients With Retinopathy of Prematurity
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objective of the study is to assess the efficacy of aflibercept compared to laser in patients diagnosed with retinopathy of prematurity (ROP). The secondary objectives of the study are to assess the need for a second treatment modality, to assess the recurrence of ROP in the study and to assess the safety and tolerability of aflibercept.
Study identification
- NCT ID
- NCT04101721
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 127 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- Not listed
- 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 29, 2019
- Primary completion
- Aug 17, 2022
- Completion
- Aug 17, 2022
- Last update posted
- Jul 19, 2023
2019 – 2022
United States locations
- U.S. sites
- 27
- U.S. states
- 13
- U.S. cities
- 24
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Regeneron Study Site | Phoenix | Arizona | 85016 | — |
| Regeneron Study Site | La Jolla | California | 92093 | — |
| Regeneron Study Site | Loma Linda | California | 92354 | — |
| Regeneron Study Site | Orange | California | 92868 | — |
| Regeneron Study Site | Palo Alto | California | 94303 | — |
| Regeneron Study Site | San Diego | California | 92123 | — |
| Regeneron Study Site | San Francisco | California | 94143 | — |
| Regeneron Study Site | Gainesville | Florida | 32608 | — |
| Regeneron Study Site | Augusta | Georgia | 78705 | — |
| Regeneron Study Site | Chicago | Illinois | 60612 | — |
| Regeneron Study Site | Boston | Massachusetts | 02111 | — |
| Regeneron Study Site | Ann Arbor | Michigan | 48105 | — |
| Regeneron Study Site | Royal Oak | Michigan | 48073 | — |
| Regeneron Study Site | Brooklyn | New York | 11203 | — |
| Regeneron Study Site | Brooklyn | New York | 11213 | — |
| Regeneron Study Site | Buffalo | New York | 14209 | — |
| Regeneron Study Site | New York | New York | 10017 | — |
| Regeneron Study Site | New York | New York | 10029 | — |
| Regeneron Study Site | The Bronx | New York | 10462 | — |
| Regeneron Study Site | Valhalla | New York | 10595 | — |
| Regeneron Study Site | Cleveland | Ohio | 44106 | — |
| Regeneron Study Site | Oklahoma City | Oklahoma | 73104 | — |
| Regeneron Study Site | Providence | Rhode Island | 02905 | — |
| Regeneron Study Site | Austin | Texas | 78705 | — |
| Regeneron Study Site | San Antonio | Texas | 78229 | — |
| Regeneron Study Site | San Antonio | Texas | 78240 | — |
| 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 25 non-U.S. sites.
Recently updated Retinopathy of Prematurity trials
Other public records listing Retinopathy of Prematurity. Sorted by last update posted; newest first. Not a recommendation.
- NCT04995341: Retinal Microanatomy in Retinopathy of Prematurity (BabySTEPS2) Recruiting
- NCT04515524: Extension Study to Evaluate the Long-Term Outcomes of Pediatric Patients Who Received Treatment for Retinopathy of Prematurity in the VGFTe-ROP-1920 Study (Acronym: Butterfleye Next) Active, not recruiting
- NCT04634578: Bevacizumab Treatment For Type 1 ROP Active, not recruiting
- NCT06109285: Validation of i-ROP DL to Detect More Than Mild ROP Active, not recruiting
- NCT05558059: Imaging Retinal Vasculature in Infant Eyes Recruiting
- NCT04420156: Clinical and Genetic Analysis of ROP Recruiting
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04101721, 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 19, 2023 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04101721 live on ClinicalTrials.gov.