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Study to Assess the Safety and Tolerability of a Single Administration of FOV2302 (Ecallantide) in Patients With Macular Edema Associated With Central Retinal Vein Occlusion

NCT00969293 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2012-01-10

No results posted yet for this study

Summary

The purpose of the study is to evaluate the safety and tolerability of a single administration of FOV2302 (ecallantide) in patients with macular edema associated with central retinal vein occlusion.

Conditions

  • Macular Edema
  • Central Retinal Vein Occlusion

Interventions

DRUG

FOV2302 (Ecallantide)

Single intravitreal injection into the relevant eye. Five dose levels will be studied from 5 to 90µg and a maximum of 6 subjects will be included at each dose level. Duration of Treatment: Single injection with 3 months follow-up.

Sponsors & Collaborators

  • Fovea Pharmaceuticals SA

    lead INDUSTRY

Principal Investigators

  • Alain Gaudric, MD · Hopital Lariboisiere

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2011-07-31
Completion
2012-03-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00969293 on ClinicalTrials.gov