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NCT01334255 · ClinicalTrials.gov registry record · Phase 1

iSONEP to Treat Persistent Pigment Epithelial Detachment (PED) in Subjects With Exudative Age-Related Macular Degeneration (AMD) or Polypoidal Choroidal Vasculopathy (PCV)

A Phase 1 study, sponsored by Lpath.

Terminated
Registry status
Phase 1
Development phase
12
Enrollment target

NCT01334255: Clinical Trial Phase 1 study, sponsored by Lpath.

NCT01334255 is a Phase 1 study that was terminated before completion, run by Lpath. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01334255, a Phase 1 study, was terminated before completion, sponsored by Lpath.

TERMINATED
Registry status
Phase 1
Development phase
12 participants
Enrollment target

Study Summary

LT1009-Oph-002 is a Phase 1b study designed to evaluate the safety and potential efficacy of iSONEP following one, two or three injections of iSONEP, as needed, for the treatment of Pigment Epithelial Detachment (PED) secondary to PED Secondary to Exudative Age-Related Macular Degeneration (AMD) or Polypoidal Choroidal Vasculopathy (PCV).

Primary Outcome

The number of participants with adverse events; changes in electrocardiogram parameters, diastolic and systolic blood pressure, pulse, temperature and intraocular pressure from baseline to the end of the study.

Interventions

  • DRUG iSONEP (sonepcizumab/LT1009)

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2011-03
Est. Completion 2012-07
Phase Phase 1
Lpath

5 total trials

Why NCT01334255 stopped before completion

NCT01334255 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).

The record links to 0 conditions, and to 1 intervention - of which iSONEP (sonepcizumab/LT1009) is the first listed.

NCT01334255 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01334255 about?

NCT01334255 is a clinical study titled "iSONEP to Treat Persistent Pigment Epithelial Detachment (PED) in Subjects With Exudative Age-Related Macular Degeneration (AMD) or Polypoidal Choroidal Vasculopathy (PCV)". LT1009-Oph-002 is a Phase 1b study designed to evaluate the safety and potential efficacy of iSONEP following one, two or three injections of iSONEP, as needed, for the treatment of Pigment Epithelial Detachment (PED) secondary to PED Secondary to Exudative Age-Related Macular Degeneration (AMD) or ...

What is the current status of trial NCT01334255?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2011-03. Estimated completion is 2012-07.

What interventions are being tested in trial NCT01334255?

The interventions under investigation include: iSONEP (sonepcizumab/LT1009) (DRUG).

Who is sponsoring clinical trial NCT01334255?

This trial is sponsored by Lpath, which has 5 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01334255's enrollment target sits among peer trials

12 1852nd of 2000 higher than 90 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 NCT01334255, the US trial registry maintained by the National Library of Medicine. NCT01334255 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.