Phase 2 Macular Degeneration Trial, Terminated NCT04437368 Sponsor: Gyroscope Therapeutics Limited 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 (NCT04437368) enrolled 98 people in total across three groups: 52 people received a lower dose of an investigational gene therapy called GT005, 9 received a higher dose, and 37 were in an untreated control group. The trial was looking at a condition called geographic atrophy (GA) — a progressive eye condition where patches of cells in the back of the eye gradually die off. The main thing being measured was how much those damaged patches grew over time, specifically the change in their size (measured in square millimetres) from the start of the trial to 48 weeks later. The reported data shows that, for the primary measure at 48 weeks, the damaged area in the low-dose group grew by approximately 2.12 mm², the high-dose group by approximately 2.38 mm², and the untreated control group by approximately 1.14 mm². For the secondary measure looking at longer-term changes, the reported data shows that by 96 weeks the low-dose group had an increase of approximately 4.84 mm², the high-dose group approximately 4.07 mm², and the untreated control group approximately 2.80 mm². These numbers represent how much the affected area changed from where each group started — they do not on their own indicate whether one group was better or worse off overall, as individual starting points varied. The reported data also shows that across both parts of the trial combined, 18 people in the low-dose group, 9 in the high-dose group, and 2 in the untreated control group experienced what are described as ocular (eye-related) adverse events — that is, undesirable medical occurrences that happened after joining the trial. Non-ocular (non-eye-related) adverse events were recorded in 13 people in the low-dose group, 8 in the high-dose group, and 14 in the untreated control group. These are counts of events that were recorded and tracked, and no further detail about their nature or severity is provided in the submitted data. 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 2 Macular Degeneration Trial, Terminated

NCT04437368
Terminated Phase 2 🇦🇺 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 willing and able to sign a consent form agreeing to take part
  • You are 55 years of age or older
  • You have been diagnosed with geographic atrophy (a form of advanced dry age-related macular degeneration, or AMD) in one eye, and have AMD in the other eye (unless you only have vision in one eye)
  • The affected area in your eye falls within a specific size range — not too small and not too large (confirm with trial site)
  • The affected area in your eye is fully visible within a special eye imaging test
  • Your vision in the study eye meets a minimum level on a standard eye chart test (confirm with trial site)
  • You are able to attend all required appointments and complete all study procedures
  • If you are a woman who could become pregnant, you must have a negative pregnancy test shortly before the study begins (this is not needed if you have gone through menopause or have had certain surgical procedures)
  • Part 1 of the trial only: You carry a specific rare gene variation linked to lower levels of a particular protein in your blood (confirm with trial site)

Who may not be able to join:

  • You have been diagnosed with a different inherited eye condition called Stargardt Disease or another retinal dystrophy
  • You have a history of, or currently have, a type of abnormal blood vessel growth (wet AMD) in the study eye
  • You have moderate or severe diabetic eye disease in the study eye
  • You have previously had certain eye surgeries in the study eye, including surgery under the retina or laser treatment to the macula
  • You have had eye surgery in the study eye within the past 12 weeks (a specific type of laser capsule procedure may be allowed if done more than 10 weeks ago — confirm with trial site)
  • You have a significant cataract in the study eye that may need surgery during the trial
  • You have moderate to severe glaucoma damage to the optic nerve, uncontrolled eye pressure even with two or more eye drop treatments, or a history of certain glaucoma surgeries in the study eye
  • You have a high level of short-sightedness (greater than -8 dioptres) in the study eye
  • You have any other significant eye or general health condition, or a mental health condition, that the doctor feels could put you at risk or affect the results
  • You have a medical reason why you cannot take the steroid medication required by this trial
  • You have received any treatment (investigational or approved) for geographic atrophy in the past 6 months or longer (standard eye vitamins such as AREDS formula are allowed)
  • You have ever received a gene therapy or cell therapy at any time
  • You are not willing to use two forms of contraception (one being a barrier method) for 90 days after receiving the treatment, if this applies to you
  • You have had an active cancer diagnosis in the past 12 months (some exceptions may apply — confirm with trial site)

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 2: approximately ~30% 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

Australian sites

The University of Melbourne - The Centre for Eye Research Australia (CERA), Melbourne E., Victoria
Sydney Hospital and Sydney Eye Hospital, 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
Terminated
Phase
Phase 2
Sponsor
Gyroscope Therapeutics Limited
Registry
ClinicalTrials.gov
Start date
26 April 2019
Est. completion
5 April 2024

Where this trial is recruiting

🇦🇺 Australia 🇫🇷 France 🇩🇪 Germany 🇳🇱 Netherlands 🇵🇱 Poland 🇪🇸 Spain 🇬🇧 United Kingdom 🇺🇸 United States

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

Primary endpoints

The Change From Baseline to Week 48 in Geographic Atrophy (GA) - Part 1

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