Phase 3 Retinal Vein Occlusion and Diabetic Macular Oedema Trial, Completed NCT01599650 Sponsor: Novartis Pharmaceuticals 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 (NCT01599650) enrolled 455 people with vision loss caused by a branch retinal vein occlusion — a blockage in a small blood vessel in the eye. Participants were split into three groups: 183 received ranibizumab injections alone, 180 received ranibizumab injections combined with laser treatment, and 92 received laser treatment alone. The trial ran for 24 months and was primarily measuring changes in vision sharpness (how many letters participants could read on a standard eye chart, scored out of 100). The reported data shows that at the start of the trial, all three groups had similar average vision scores — around 57–60 letters. By the six-month mark (the main measurement point), the ranibizumab-alone group's average score had risen to about 74 letters (a reported gain of roughly 15 letters), the ranibizumab-plus-laser group's average rose to about 71 letters (also a reported gain of roughly 15 letters), and the laser-alone group's average rose to about 63 letters (a reported gain of roughly 6 letters). These trends continued through to 12 and 24 months, with the reported data showing the two ranibizumab groups continuing to show larger average gains than the laser-only group. Regarding the proportion of participants who gained 15 or more letters at six months, the reported figures were approximately 83% in the ranibizumab-alone group, 89% in the ranibizumab-plus-laser group, and 70% in the laser-alone group. Participants in the two ranibizumab groups received an average of approximately 11 injections each over the 23-month treatment period. 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

NCT01599650
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 must be willing and able to sign a consent form before any study tests are done.
  • Your vision problems must be caused only by fluid build-up in the centre of your eye (macular oedema) due to a blockage in a branch vein in your eye (branch retinal vein occlusion).
  • Your vision in the affected eye must fall within a specific range when tested using a standard eye chart (a score between 19 and 73 letters on the ETDRS chart — roughly moderate to moderately severe vision loss).

Who may not be able to join:

  • Women who are pregnant or currently breastfeeding.
  • People who have had a stroke or heart attack within the last 3 months before the screening visit.
  • People with high blood pressure that is not well controlled (above certain set levels) at the time of screening or the start of the study.
  • People who have an active infection or inflammation in or around either eye at the time of screening or the start of the study.
  • People with glaucoma that is not well controlled, or who were diagnosed with glaucoma within the last 6 months, in either eye.
  • People who have abnormal new blood vessel growth on the iris or a type of glaucoma caused by new blood vessels in the eye being treated.
  • People who have taken certain medications that block blood vessel growth (anti-VEGF drugs) by mouth or injection into the body within the last 6 months.
  • People who have had a specific type of laser treatment covering a wide area of the retina within the last 3 months, or who have this planned in the next 3 months, in the eye being treated.
  • People who have had a more targeted laser treatment to the retina within the last 4 months in the eye being treated.
  • People who have had steroid medication injected in or around the eye being treated within the last 3 months before screening.
  • People who have ever had a long-acting steroid implant placed inside the eye being treated (such as Ozurdex® or Iluvien®).

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 20 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: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Australian sites

Novartis Investigative Site, Parramatta, New South Wales
Novartis Investigative Site, Sydney, New South Wales
Novartis Investigative Site, Melbourne, Victoria
Novartis Investigative Site, Nedlands, Western Australia

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

GP referral letter

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Trial details

Status
Completed
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
1 May 2012
Est. completion
1 May 2015

Where this trial is recruiting

🇦🇺 Australia 🇨🇦 Canada 🇨🇿 Czechia 🇩🇰 Denmark 🇫🇷 France 🇬🇷 Greece 🇭🇺 Hungary 🇮🇪 Ireland 🇮🇹 Italy 🇳🇱 Netherlands 🇵🇱 Poland 🇵🇹 Portugal 🇸🇰 Slovakia 🇪🇸 Spain 🇸🇪 Sweden 🇨🇭 Switzerland 🇬🇧 United Kingdom

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

Primary endpoints

Mean Change in Visual Acuity: BCVA Change at Month 6 Compared to Baseline in Patients With Visual Impairment Due to Branch Retinal Vein Occlusion (BRVO)

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: 20 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