Phase 3 Retinal Vein Occlusion and Diabetic Macular Oedema Trial, Completed NCT00168324 Sponsor: Allergan Condition: Retinal Vein Occlusion and Diabetic Macular Oedema
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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 599 people in total across three groups. Participants received either a 700 microgram (µg) dose of a medicine called dexamethasone (201 people), a 350 µg dose of dexamethasone (196 people), or a sham (dummy) injection (202 people). The trial was looking at changes in vision in the treated eye, specifically whether people could read 15 or more additional letters on an eye chart compared to when they started — a commonly used way of measuring a meaningful improvement in vision. The trial also measured changes in the thickness of the retina (the light-sensitive layer at the back of the eye) over time. The reported data shows that the main outcome was tracked using a statistical method called a Kaplan-Meier estimate, which accounts for people who left the study early. This estimate runs from 0 to 1, where a higher number means a greater likelihood of achieving that 15-letter improvement. At the 180-day mark, the reported estimates were 0.397 for the 700 µg group, 0.349 for the 350 µg group, and 0.225 for the sham group. For retinal thickness, the reported data shows an average reduction (improvement) of about 199 µm in the 700 µg group, 144 µm in the 350 µg group, and 78 µm in the sham group at day 90. At the 180-day mark, all three groups showed smaller reductions — around 105 µm, 91 µm, and 110 µm respectively. Regarding vision category changes at day 90, 22.4% of the 700 µg group, 20.9% of the 350 µg group, and 12.4% of the sham group were reported to have improved by 15 or more letters. 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 3 Retinal Vein Occlusion and Diabetic Macular Oedema Trial, Completed

NCT00168324
Completed Phase 3 🇦🇺 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 18 years of age or older and have swelling in the central part of your retina (called macular edema) caused by a blocked vein in your eye
  • Your vision in at least one eye has gotten worse because of this swelling, with eyesight of 20/50 or poorer (meaning you need to be closer to see what someone with normal vision can see from further away)
  • Your other eye still has vision no worse than 20/200

Who may not be able to join:

  • You are expected to need eye surgery within the next 12 months
  • You have a history of glaucoma, or currently have high pressure in your eye that requires more than one medication to control
  • You have diabetic retinopathy (eye damage caused by diabetes)
  • You have a serious ongoing health condition that is not well controlled
  • You are known to have a strong reaction to steroid medications in your eyes (confirm with trial site)
  • You are currently taking steroid medications in pill or injection form
  • You are currently taking blood-thinning medications such as warfarin or heparin

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 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Medical Director, Allergan

Australian sites

, Sydney,

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 3
Sponsor
Registry
ClinicalTrials.gov
Start date
1 October 2004
Est. completion
1 March 2008

Where this trial is recruiting

🇦🇺 Australia 🇦🇹 Austria 🇨🇦 Canada 🇨🇿 Czechia 🇫🇷 France 🇩🇪 Germany 🇮🇱 Israel 🇲🇽 Mexico 🇵🇭 Philippines 🇵🇹 Portugal 🇿🇦 South Africa 🇹🇼 Taiwan 🇺🇸 United States

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

Primary endpoints

Cumulative Response Rate of 15 or More Letter Improvement

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