Phase 3 Macular Degeneration Trial, Recruiting NCT07189169 Sponsor: Smilebiotek Zhuhai Limited Condition: Macular Degeneration
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Phase 3 Macular Degeneration Trial, Recruiting

NCT07189169
Recruiting Phase 3

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:

  • The eye being studied has been diagnosed with intermediate age-related macular degeneration (a condition affecting central vision) according to standard medical criteria
  • The eye being studied has at least one large deposit under the retina (called a drusen) measuring 125 micrometres or wider in the central area of the eye
  • A Traditional Chinese Medicine (TCM) assessment has identified a specific pattern described as "Yang-hyperactivity due to Yin-deficiency" (confirm with trial site)
  • People aged 45 to 85 years, of any gender
  • The eye being studied has a measured vision level falling within a specific range — roughly between normal vision and moderately reduced vision (20/20 to 20/200 on a standard eye chart)
  • Willingness to participate voluntarily and to sign an informed consent form

Who may not be able to join:

  • The eye being studied has other eye conditions that could interfere with the trial, such as severe short-sightedness, glaucoma, diabetic eye disease, blocked retinal veins, eye inflammation, detached retina, optic nerve problems, or a hole in the macula
  • The eye being studied has an eye pressure reading of 25 mmHg or higher
  • There is an area of significant retinal tissue loss (geographic atrophy) affecting the central point of vision in the eye being studied
  • The eye being studied has previously had certain surgeries, including vitrectomy or macular translocation surgery
  • The eye being studied is missing its natural lens without a replacement, or has a ruptured lens capsule (with some exceptions — confirm with trial site)
  • The eye being studied has had any eye surgery (other than injections into the eye) within the past 3 months that could affect trial results or imaging
  • A cataract in the eye being studied that blocks a clear view of the back of the eye
  • The eye being studied has received certain laser treatments within the 3 months before screening
  • The person has received relevant Traditional Chinese Medicine treatment within 1 month before screening
  • There is an active eye infection in either eye that affects examination or imaging
  • The other eye (not being studied) has very poor vision below a certain level on the standard eye chart
  • A known allergy to any of the medications or diagnostic substances used in the trial
  • Blood pressure that remains poorly controlled (above certain levels) despite taking blood pressure medication
  • Certain abnormal blood test results, including low platelet counts or elevated liver or kidney markers (confirm with trial site)
  • People who are pregnant, breastfeeding, planning a pregnancy within six months, or unwilling to use effective contraception during the trial and for six months after finishing the study medication
  • Serious uncontrolled health conditions, including severe psychiatric, neurological, breathing, immune system, blood, or heart conditions, or active cancer
  • Participation in another clinical trial within the 3 months before this trial
  • People considered unsuitable by the trial investigator for any reason

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

Phone: 010-85132171

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
Recruiting
Phase
Phase 3
Sponsor
Smilebiotek Zhuhai Limited
Registry
ClinicalTrials.gov
Start date
8 July 2025
Est. completion
1 March 2027

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Percentage change from baseline in drusen area

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