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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 is a Phase 3 study that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 127 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04101721
The ClinicalTrials.gov registry entry for NCT04101721 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 127 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Regeneron Pharmaceuticals, which has 280 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which aflibercept is the first listed.
NCT04101721 reports 0 study locations.
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.
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