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Safety and Efficacy Study of Topical Administration of FOV2304 (High Dose or Low Dose) for the Treatment of Center-involving Clinically Significant Macular Edema Associated With Diabetic Retinopathy

NCT01319487 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 267

Last updated 2012-08-23

No results posted yet for this study

Summary

The purpose of the study is to determine whether concentrations of FOV2304 (high dose or low dose) administered in the eye are more effective than placebo in treating patients with diabetic macular edema, following 12 weeks of treatment.

Conditions

Interventions

DRUG

2304 Eye Drops High Dose

2304 Eye Drops High Dose self-administered in the study eye during the treatment period

DRUG

2304 Eye Drops Low Dose

2304 Eye Drops Low Dose self-administered in the study eye during the treatment period

DRUG

Placebo Eye Drops

Placebo Eye Drops self-administered in the study eye during the treatment period

Sponsors & Collaborators

  • Fovea Pharmaceuticals SA

    lead INDUSTRY

Principal Investigators

  • Pascale Massin, MD · Lariboisière Hospital, Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2012-03-31
Completion
2012-06-30

Countries

  • United States
  • Australia
  • Belgium
  • Czechia
  • France
  • Germany
  • Israel
  • Italy
  • Poland
  • Spain

Study Locations

More Related Trials

Entities

Diseases

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 NCT01319487 on ClinicalTrials.gov