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Re-implantation of a Fluocinolone Acetonide Implant for Non-infectious Uveitis Affecting the Posterior Segment

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Duke University

Status and phase

Completed
Phase 4

Conditions

Uveitis

Treatments

Drug: 0.59 mg Fluocinolone Acetonide implant

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00543296
Pro00013641

Details and patient eligibility

About

The purpose of this study is to collect data on patients with severe uveitis that have required re-implantation of the sustained-release fluocinolone drug delivery device due to depletion of study drug in their previous implanted device.

Full description

Purpose: To collect medical information on a sustained release drug delivery system that delivers the corticosteroid, fluocinolone acetonide, directly into the vitreous cavity of the eye. This system has the potential to maintain therapeutic drug levels in the eye while reducing systemic exposure to the drug to negligible levels. RetisertTM is the trade name for the intravitreal fluocinolone acetonide implant.

Hypothesis: The RetisertTM will be a safe and effective method to manage patients with severe uveitis

Enrollment

21 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Non-infectious intermediate, posterior or panuveitis
  • Previous placement of fluocinolone acetonide implant with initial uveitis quiescence and subsequent recurrence of inflammation once implant depleted of drug

Exclusion criteria

  • Infectious uveitis

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

21 participants in 1 patient group

0.59 mg Fluocinolone Acetonide implant
Experimental group
Description:
0.59 mg Fluocinolone Acetonide implant
Treatment:
Drug: 0.59 mg Fluocinolone Acetonide implant

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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