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NCT01994291 · ClinicalTrials.gov registry record · Phase 2

A Phase 2, Multi-Center Study To Compare The Efficacy And Safety Of A Chemokine CCR2/5 Receptor Antagonist With Ranibizumab In Adults With Diabetic Macular Edema

A Phase 2 study, sponsored by Pfizer.

Terminated
Registry status
Phase 2
Development phase
199
Enrollment target

NCT01994291: Clinical Trial Phase 2 study, sponsored by Pfizer.

NCT01994291 is a Phase 2 study that was terminated before completion, run by Pfizer. The registered enrollment target is 199 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01994291, a Phase 2 study, was terminated before completion, sponsored by Pfizer.

TERMINATED
Registry status
Phase 2
Development phase
199 participants
Enrollment target

Study Summary

The study hypothesis under test is that administration of the CCR2/5 antagonist has the potential to be as effective as the current treatment options for subjects with diabetic macular edema. The current treatment option for these subjects is an injection directly into the eye, while this CCR2/5 antagonist would be an oral drug which has the potential to be just as effective. This CCR2/5 antagonist also has a broader anti-inflammatory potential and might be able to provide an alternative mechanism to treat Diabetic Macular Edema.

Primary Outcome

Refraction and visual acuity were assessed through the BCVA obtained using the retro illuminated early treatment diabetic retinopathy study (ETDRS) charts. Distance visual acuity was expressed as an ETDRS score (number of letters correctly read).

Interventions

  • DRUG Placebo
  • DRUG Ranibizumab
  • DRUG PF-04634817
  • DRUG Masked Sham Therapy

Trial Details

FieldValue
Enrollment Target 199 participants
Start Date 2013-11
Est. Completion 2015-08
Phase Phase 2
Pfizer

1,845 total trials

Why NCT01994291 stopped before completion

NCT01994291 is an interventional study that assigns participants to a tested intervention. The registered 199 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% higher).

The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.

NCT01994291 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01994291 about?

NCT01994291 is a clinical study titled "A Phase 2, Multi-Center Study To Compare The Efficacy And Safety Of A Chemokine CCR2/5 Receptor Antagonist With Ranibizumab In Adults With Diabetic Macular Edema". The study hypothesis under test is that administration of the CCR2/5 antagonist has the potential to be as effective as the current treatment options for subjects with diabetic macular edema. The current treatment option for these subjects is an injection directly into the eye, while this CCR2/5 ant...

What is the current status of trial NCT01994291?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 199 participants. The study started on 2013-11. Estimated completion is 2015-08.

What interventions are being tested in trial NCT01994291?

The interventions under investigation include: Placebo (DRUG), Ranibizumab (DRUG), PF-04634817 (DRUG), Masked Sham Therapy (DRUG).

Who is sponsoring clinical trial NCT01994291?

This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01994291's enrollment target sits among peer trials

199 349th of 2000 higher than 1,652 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT01994291, the US trial registry maintained by the National Library of Medicine. NCT01994291 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.