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Completed Phase 3 Interventional Results available

Study to Assess the Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Compared to Laser Photocoagulation in Patients With Retinopathy of Prematurity

ClinicalTrials.gov ID: NCT04101721

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.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 2:36 AM EDT

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
Lead sponsor
Regeneron Pharmaceuticals
Industry
Enrollment
127 participants

Conditions and interventions

Interventions

Drug · Procedure

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 30, 2019 (Actual)
Primary completion
Aug 18, 2022 (Actual)
Completion
Aug 18, 2022 (Actual)
Last update posted
Jul 20, 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.

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 20, 2023 · 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 NCT04101721 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →