Phase 3 Macular Degeneration Trial, Completed NCT05536297 Sponsor: Astellas Pharma Global Development, Inc. Condition: Macular Degeneration
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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 (NCT05536297) enrolled a total of 278 participants across three groups. One group (64 people) received a treatment called ACP every month throughout the whole study. A second group (62 people) had previously received ACP on a mixed schedule — sometimes every month, sometimes every other month — and then switched to receiving it every month. A third group (152 people) had previously received a sham (inactive/dummy) treatment and then switched to receiving ACP every month. The trial was primarily measuring how many participants experienced any unwanted medical events (called adverse events), and secondarily looking at whether the body developed any antibody response to the drug, as well as measuring the levels of ACP in the blood over time. The reported data shows that, when it came to unwanted medical events, 50 out of 64 participants in the first group, 49 out of 62 in the second group, and 129 out of 152 in the third group had at least one such event recorded during the trial. Regarding antibody responses to the drug, the reported data shows that 1 participant in the first group, 0 in the second group, and 2 in the third group developed a detectable antibody response. For blood levels of ACP measured in units called ng/mL (nanograms per millilitre, a measure of how much of the drug was present in the blood), the reported data shows a range of measurements across different time points for each group; notably, the sham group started with very low levels (0.044 ng/mL) before switching to ACP, after which their levels rose to be broadly similar to the other groups (ranging from around 31 to 38 ng/mL across the later time points). 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 Macular Degeneration Trial, Completed

NCT05536297
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 aged 50 or older and have been diagnosed with geographic atrophy (a type of eye condition causing vision loss) that affects the centre and/or outer areas of the eye
  • You must have fully completed the previous related study called GATHER2 (ISEE2008), including attending the 24-month visit while on the study treatment
  • You must be willing and able to sign a new consent form agreeing to take part in this new study
  • You must be able to attend all required visits over the 18-month length of this trial

Who may not be able to join:

  • You did not complete the previous GATHER2 study through the 24-month visit while on the study treatment (whether that was the active drug or a sham/dummy procedure)
  • You had the study drug permanently stopped during the GATHER2 study due to a side effect or medical reaction
  • You did not sign up for this new trial within the 90-day enrolment window after the previous study ended
  • You are currently pregnant or breastfeeding

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 27 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, Astellas Pharma Global Development, Inc.

Australian sites

Centre for Eye Research Australia, East Melbourne,
Sydney Retina Clinic, 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
Astellas Pharma Global Development, Inc.
Registry
ClinicalTrials.gov
Start date
26 September 2022
Est. completion
10 April 2025

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇦🇹 Austria 🇧🇪 Belgium 🇧🇷 Brazil 🇨🇦 Canada 🇨🇴 Colombia 🇭🇷 Croatia 🇨🇿 Czechia 🇫🇷 France 🇩🇪 Germany 🇭🇺 Hungary 🇮🇱 Israel 🇮🇹 Italy 🇱🇻 Latvia 🇪🇸 Spain 🇺🇸 United States

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

Primary endpoints

Number of Participants With Adverse Events (AEs)

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: 27 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