Phase 4 Uveitis Trial, Completed NCT00132691 Sponsor: JHSPH Center for Clinical Trials Condition: Uveitis
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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial enrolled 255 people in total — 129 in the group that received a fluocinolone acetonide intraocular implant (a small device surgically placed inside the eye to slowly release medicine) and 126 in the group that received standard systemic treatment (medicines taken by mouth or injection that work throughout the whole body). The trial was measuring how each approach affected vision and eye health in people with uveitis (a condition involving inflammation inside the eye) over 24 months. The reported data shows that, for the primary outcome — change in the number of letters read on a standard eye chart — the implant group improved by an average of 6.0 letters and the systemic treatment group improved by an average of 3.2 letters from the start of the trial. Note that the researchers considered a change of 7.5 letters to be clinically meaningful, so neither group's average change reached that threshold. For secondary outcomes, the reported data shows that 22% of eyes in the implant group had macular swelling (fluid build-up at the back of the eye) compared with 30% in the systemic treatment group, and 12% of eyes in the implant group showed signs of active inflammation compared with 29% in the systemic treatment group. However, the reported data also shows notably higher rates of elevated eye pressure in the implant group across all three eye pressure measures: for example, 32.8% of implant-group eyes reached a high pressure reading (≥30 mmHg, a unit used to measure pressure in the eye) compared with 6.3% in the systemic treatment group, and similar patterns were seen at lower pressure thresholds and for large pressure rises from baseline. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 4 Uveitis Trial, Completed

NCT00132691
Completed Phase 4 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are 13 years old or older
  • You have at least some vision (able to detect hand movement or better) in at least one eye affected by uveitis
  • The pressure inside your affected eye(s) is at a normal or acceptable level (24 mm Hg or lower)

Who may not be able to join:

  • You have diabetes that is not well managed or controlled
  • You have glaucoma that is not well controlled
  • You have severe damage to the optic nerve caused by glaucoma
  • You have a history of scleritis (inflammation of the white part of the eye) or have scarring in your eye from a condition called ocular toxoplasmosis
  • You have HIV or another condition that weakens your immune system, where steroid treatment would not be considered safe for you (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Douglas Jabs, MD, MBA, Icahn School of Medicine at Mount Sinai

Australian sites

Royal Victoria Eye & Ear Hospital, East Melbourne,

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Completed
Phase
Phase 4
Sponsor
JHSPH Center for Clinical Trials
Registry
ClinicalTrials.gov
Start date
1 September 2005
Est. completion
1 December 2010

Where this trial is recruiting

🇦🇺 Australia 🇬🇧 United Kingdom 🇺🇸 United States

1 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Change in Best-corrected Visual Acuity (Change in the Numbers of Letters Read From a Standard ETDRS Eye Chart) From Baseline to 24 Months in Eyes With Uveitis

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov