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NCT01997164 · ClinicalTrials.gov registry record · Phase 1

Study of Intravitreal (IVT) REGN910-3 and IVT REGN910 in Patients With Either Neovascular ("Wet") Age Related Macular Degeneration (AMD) or Diabetic Macular Edema (DME)

A Phase 1 study, sponsored by Regeneron Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
20
Enrollment target

NCT01997164: Completed Phase 1 study, sponsored by Regeneron Pharmaceuticals.

NCT01997164 is a Phase 1 study that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01997164, a Phase 1 study, has completed, sponsored by Regeneron Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
20 participants
Enrollment target

Study Summary

The primary objective of the study is to investigate the safety and tolerability of intravitreal (IVT) REGN910-3 and IVT REGN910 in patients with neovascular age-related macular degeneration (AMD), and separately in patients with diabetic macular edema (DME).

Primary Outcome

Incidence of TEAEs through week 24 in patients treated with IVT REGN910-3 and IVT REGN910 TEAEs through week 24 in patients treated with IVT REGN910-3 and IVT REGN910

Interventions

  • DRUG REGN910-3
  • DRUG Intravitreal Aflibercept Injection (IAI)
  • DRUG REGN910

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2014-11
Est. Completion 2015-10
Phase Phase 1
Regeneron Pharmaceuticals

280 total trials

What the finished NCT01997164 record still lists

NCT01997164 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).

The record links to 0 conditions, and to 3 interventions - of which REGN910-3 is the first listed.

NCT01997164 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01997164 about?

NCT01997164 is a clinical study titled "Study of Intravitreal (IVT) REGN910-3 and IVT REGN910 in Patients With Either Neovascular ("Wet") Age Related Macular Degeneration (AMD) or Diabetic Macular Edema (DME)". The primary objective of the study is to investigate the safety and tolerability of intravitreal (IVT) REGN910-3 and IVT REGN910 in patients with neovascular age-related macular degeneration (AMD), and separately in patients with diabetic macular edema (DME).

What is the current status of trial NCT01997164?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2014-11. Estimated completion is 2015-10.

What interventions are being tested in trial NCT01997164?

The interventions under investigation include: REGN910-3 (DRUG), Intravitreal Aflibercept Injection (IAI) (DRUG), REGN910 (DRUG).

Who is sponsoring clinical trial NCT01997164?

This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01997164's enrollment target sits among peer trials

20 1629th of 2000 higher than 285 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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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Source: ClinicalTrials.gov NCT01997164, the US trial registry maintained by the National Library of Medicine. NCT01997164 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.