Phase 3 Uveitis Trial, Completed NCT02623426 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 (NCT02623426) enrolled 194 people across three groups. Each group received a different treatment injected into the eye for a condition affecting the retina: 65 people received a dexamethasone pellet (Ozurdex), 65 received methotrexate, and 64 received ranibizumab (Lucentis). The trial was measuring changes in the thickness of a specific layer at the centre of the retina — called the central subfield — using eye-scanning technology, comparing thickness at the start of the trial to thickness at 12 weeks. Most participants completed the study, with only a small number (1–3 per group) not finishing. The reported data shows the primary outcome as a proportion — that is, a fraction of the original retinal thickness measured at the start. A number below 1.0 means the retina appeared thinner at 12 weeks compared to the start, with lower numbers representing a greater reduction in thickness. According to the results reported on ClinicalTrials.gov, at 12 weeks the dexamethasone group had a reported proportion of 0.65 (meaning the retina measured about 65% of its original thickness), the methotrexate group had a proportion of 0.88 (about 88% of original thickness), and the ranibizumab group had a proportion of 0.79 (about 79% of original thickness). No other outcome measures were included in the submitted results data. Data on secondary outcomes, if any were collected, was not reported in the structured results available. 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 Uveitis Trial, Completed

NCT02623426
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
  • You have non-infectious uveitis (inflammation inside the eye) that is inactive or only very mildly active, and has been that way for at least 4 weeks
  • You have swelling in the central part of your retina (called macular edema), confirmed by a specific eye scan, that developed after receiving a steroid injection into the eye
  • You have had a specific eye imaging test (fluorescein angiogram) that gives clear enough results to measure fluid leakage in the centre of your eye
  • Your vision in the affected eye is at least 5/200 (some ability to see, even if limited)
  • Your eye pressure is within a specific range (between 5 and 21 mmHg), with or without up to 3 pressure-lowering eye drop medications or previous glaucoma surgery
  • The inside of your eye is clear enough to allow scanning and examination

Who may not be able to join:

  • You have a history of infectious uveitis (eye inflammation caused by infection) in either eye
  • You have a history of infectious scleritis (infection-related inflammation of the white of the eye) in either eye
  • You have a history of corneal infection (keratitis), unless it was caused by dry eye, in either eye
  • You have a history of central serous retinopathy (a condition where fluid builds under the retina) in either eye
  • You currently have an active eye infection (conjunctivitis) in either eye
  • You are taking more than 10 mg per day of oral prednisone (or an equivalent steroid), or your current lower dose has not been stable for at least 4 weeks
  • You are taking immune-suppressing medications that have not been at a stable dose for at least 4 weeks (methotrexate is allowed if the dose has been stable for 4 weeks)
  • You are currently taking acetazolamide or a similar oral medication for eye pressure
  • You have a known allergy or sensitivity to any ingredients in the study medications
  • You are pregnant, breastfeeding, have a positive pregnancy test, or are unwilling to use reliable contraception throughout the trial (if you are a woman who could become pregnant)
  • You have a history of a serious eye infection inside the eye (infectious endophthalmitis)
  • You have severe glaucoma with significant damage to the optic nerve
  • You have had active non-infectious scleritis in the past 12 months
  • You have scar tissue on the surface of your retina (epiretinal membrane) that the study doctor believes could prevent the swelling from improving
  • You have a torn or damaged lens capsule in the eye
  • You have silicone oil present in the eye
  • You received a dexamethasone eye implant (Ozurdex) in the past 12 weeks
  • You received certain eye injections (anti-VEGF agents, methotrexate, or steroid injections in or around the eye) in the past 4 weeks
  • You have had a fluocinolone acetonide implant (Retisert) placed in the eye in the past 3 years

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: Douglas A Jabs, MD, MBA, Center for Clinical Trials and Evidence Synthesis, JHU, Baltimore, MD

Australian sites

Royal Victorian Eye and Ear Hospital, East Melbourne, Victoria

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
JHSPH Center for Clinical Trials
Registry
ClinicalTrials.gov
Start date
9 March 2017
Est. completion
27 October 2021

Where this trial is recruiting

🇦🇺 Australia 🇨🇦 Canada 🇮🇳 India 🇬🇧 United Kingdom 🇺🇸 United States

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

Primary endpoints

Proportion of Baseline Central Subfield Thickness Observed at 12 Weeks

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