Phase 3 Retinal Vein Occlusion and Diabetic Macular Oedema Trial, Completed NCT04740931 Sponsor: Hoffmann-La Roche 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 (NCT04740931) enrolled 729 participants in total — 366 in Arm A (receiving faricimab every four weeks) and 363 in Arm B (receiving aflibercept every four weeks) during the first part of the study (up to 24 weeks). In the second part of the study (weeks 24 to 72), both groups switched to or continued faricimab on a personalised dosing schedule. The trial was primarily measuring changes in vision sharpness — specifically, how many letters participants could read on a standardised eye chart — compared to where they started at the beginning of the study. The reported data shows that by week 24 (the primary measurement point), participants in Arm A gained an average of 16.9 letters on the eye chart from their starting score, while participants in Arm B gained an average of 17.3 letters. On a secondary measure looking at the proportion of participants who gained 15 or more letters by week 24 — roughly considered a meaningful improvement in vision sharpness — the reported figures were 56.6% in Arm A and 58.1% in Arm B. The reported data also shows that around 72–73% of participants in Arm A and 73–75% in Arm B gained 10 or more letters by week 24, and approximately 85–87% in each group gained 5 or more letters at that same point. These numbers were tracked at several check-in points throughout the 24-week period, and the reported data shows the gains in letter scores generally increased over the first few weeks and then remained relatively steady through to week 24 in both groups. 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

NCT04740931
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 have swelling at the centre of your retina (the back of your eye) caused by a blocked vein in the eye, and this was diagnosed no more than 4 months before the screening visit
  • Your vision (with glasses or contact lenses if you wear them) falls within a specific range — roughly between 20/40 and 20/400 on a standard eye chart
  • Your eye is clear enough and your pupil can be widened enough to allow good-quality photographs of the back of your eye to confirm your diagnosis
  • If you are a woman who could become pregnant: you agree to avoid pregnancy and not donate eggs during the treatment and for 3 months after your last dose, either by abstaining from sex or using contraception

Who may not be able to join:

  • You have had a major illness or major surgery within the month before your screening appointment
  • You have high blood pressure that is not under control
  • You have had a stroke or heart attack within the 6 months before the study start date
  • You are currently pregnant, breastfeeding, or planning to become pregnant during the study
  • Your affected eye has had a previous episode of retinal swelling from a blocked vein, or the current swelling was first diagnosed more than 4 months before screening
  • Your affected eye has another condition that is causing or could cause permanent vision loss for reasons unrelated to the blocked vein (confirm with trial site)
  • You have had a specific type of laser treatment (macular laser) on your affected eye at any time before the study start date
  • You have had a full-eye laser treatment (panretinal photocoagulation) on your affected eye within 3 months before the study start, or one is planned within 3 months of starting
  • You have ever received any previous treatment for retinal swelling or related eye conditions in your affected eye, including injections into the eye, certain laser therapies, or eye surgery (confirm with trial site for specific treatments)
  • You have ever had a specific light-activated therapy, a type of heat-based laser, or surgery on the inside of your eye in the affected eye
  • You have ever had a steroid implant placed inside your affected eye (such as Ozurdex or Iluvien)
  • You have previously received an injection of a drug called faricimab in either eye
  • You have a history of eye inflammation linked to an immune or unknown cause in either eye
  • You currently have or are suspected to have an active infection or inflammation in or around either eye on the day the study begins

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: Clinical Trials, Hoffmann-La Roche

Australian sites

Eyeclinic Albury Wodonga, Albury, New South Wales
Strathfield Retina Clinic, Strathfield, New South Wales
Save Sight Institute, Sydney, New South Wales
Sydney Retina Clinic and Day Surgery, Sydney, New South Wales
Centre For Eye Research Australia, East Melbourne, Victoria
Retina Specialists Victoria, Rowville, Victoria
The Lions Eye Institute, Nedlands, Western Australia

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
Registry
ClinicalTrials.gov
Start date
2 March 2021
Est. completion
9 August 2022

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇦🇹 Austria 🇧🇷 Brazil 🇨🇳 China 🇨🇿 Czechia 🇫🇷 France 🇩🇪 Germany Hong Kong 🇭🇺 Hungary 🇮🇱 Israel 🇮🇹 Italy 🇯🇵 Japan 🇵🇱 Poland 🇵🇹 Portugal 🇷🇺 Russia 🇸🇬 Singapore 🇰🇷 South Korea 🇪🇸 Spain 🇹🇼 Taiwan 🇬🇧 United Kingdom 🇺🇸 United States

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

Primary endpoints

Part 1: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 24

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