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Fluocinolone Acetonide Implant for Retinal Vein Occlusion (RVO)

NCT00636493 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2012-12-12

No results posted yet for this study

Summary

Purpose: To determine whether a fluocinolone acetonide sustained drug delivery implant is effective in the treatment of retinal vein occlusion that has caused persistent macular edema and decreased visual acuity.

Hypothesis: A fluocinolone acetonide sustained drug delivery implant will be a safe and effective method to treat patients with macular edema and decreased vision from retinal vein occlusion.

Conditions

  • Retinal Vein Occlusion

Interventions

DEVICE

fluocinolone acetonide (Retisert Implant)

sustained release device consisting of 0.59 mg of fluocinolone acetonide

Sponsors & Collaborators

  • Bausch & Lomb Incorporated

    collaborator INDUSTRY

  • Glenn Jaffe

    lead OTHER

Principal Investigators

  • Glenn J Jaffe, MD · Duke Eye Center, DUMC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-10-31
Primary Completion
2009-05-31
Completion
2009-05-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT00636493 on ClinicalTrials.gov