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NCT04101721 · ClinicalTrials.gov registry record · Phase 3
Study to Assess the Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Compared to Laser Photocoagulation in Patients With Retinopathy of Prematurity
A Phase 3 study, sponsored by Regeneron Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 127
- Enrollment target
NCT04101721: Completed Phase 3 study, sponsored by Regeneron Pharmaceuticals.
NCT04101721 is a Phase 3 study that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 127 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04101721, a Phase 3 study, has completed, sponsored by Regeneron Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 127 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Active ROP was ROP requiring treatment and unfavorable structural outcome was defined as retinal detachment, macular dragging, macular fold, or retrolental opacity. For participants with both eyes enrolled in the study, both eyes must have met the endpoint. Participants with only one study eye enrolled were responders if the respective eye responded.
Interventions
- DRUG aflibercept
- PROCEDURE laser photocoagulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 127 participants |
| Start Date | 2019-10-30 |
| Est. Completion | 2022-08-18 |
| Phase | Phase 3 |
What the finished NCT04101721 record still lists
NCT04101721 is an interventional study that assigns participants to a tested intervention. The registered 127 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 2 interventions - of which aflibercept is the first listed.
NCT04101721 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04101721 about?
NCT04101721 is a clinical study titled "Study to Assess the Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Compared to Laser Photocoagulation in Patients With Retinopathy of Prematurity". 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...
What is the current status of trial NCT04101721?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 127 participants. The study started on 2019-10-30. Estimated completion is 2022-08-18.
What interventions are being tested in trial NCT04101721?
The interventions under investigation include: aflibercept (DRUG), laser photocoagulation (PROCEDURE).
Who is sponsoring clinical trial NCT04101721?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04101721's enrollment target sits among peer trials
127 1602nd of 2000 higher than 398 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
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