Phase 1 study for people with Macular Degeneration
Recruiting Phase 1
This trial at a glance
Where this trial is running
| Site | City | State or country | Status at this site |
|---|---|---|---|
| Nucleus Network | Melbourne | VIC | Recruiting |
voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice
Who can join
The official eligibility criteria
Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.
Key Inclusion Criteria (Part A):
1. Willing and able to provide written informed consent form
2. Be aged 18 to 45 years (inclusive) at the time of signing the informed consent form
3. Generally healthy on medical history, exam, labs, and ECG
4. BCVA 20/25 or better in each eye
5. Serum retinol above protocol threshold
6. Body weight ≥40 kg and BMI of 18.0 to 32.0 kg/m2
7. Men and WOCBP must agree to use highly effective methods of contraception or practice abstinence from 30 days before the first dose of CITY-RBP4, throughout the study, and for at least 180 days after treatment with CITY-RBP4 or the last study visit, whichever is longer; men must refrain from donating or banking sperm during the same period
8. Female participants who are not WOCBP should meet at least 1 of the following criteria: have undergone a documented hysterectomy, bilateral oophorectomy, and/or bilateral salpingectomy; have medically confirmed ovarian failure, or achieved postmenopausal status
Key Exclusion Criteria (Part A):
1. Clinically significant ocular disease or prior ocular surgery that could interfere with safety assessments
2. History of vitamin A deficiency, malabsorption, or chronic diarrhea
3. Clinically significant cardiac, hepatic, renal, pulmonary, neurologic, or psychiatric disease
4. Positive hepatitis B, hepatitis C, or HIV screening
5. Prior RNAi/oligonucleotide therapy or recent investigational treatment
6. Recent vitamin A-related supplements, retinoids, or medications affecting vitamin A metabolism
7. Pregnancy or breastfeeding, if applicable
Key Inclusion Criteria (Parts B and C)
1. Participants aged 12 to 45 years
2. Clinical diagnosis of STGD1 with documented ABCA4 pathogenic/likely pathogenic variant
3. Minimum BCVA is required in the study eye
4. Subjects must have a defined aggregate atrophic lesion in 1 or both eyes
5. Body weight ≥40 kg
6. Able to complete key ophthalmic safety assessments and comply with study precautions
Key Exclusion Criteria (Parts B and C)
1. Ocular conditions that could confound retinal imaging or safety evaluation
2. Prior ocular gene therapy, stem cell therapy, or retinal implant
3. Vitamin A deficiency or recent prohibited vitamin A-related treatments
4. Recent interventional study participation
5. Clinically significant non-ophthalmic disease, abnormal screening labs/ECG, or positive hepatitis B, hepatitis C, or HIV screening
6. Pregnancy or breastfeeding, if applicable
Dates on the record
Results, publications and the official record
- No results are posted on the official record yet.
- No publications are listed on the official record yet.
- Official record and contacts on ClinicalTrials.gov – contact details for each site are kept there, and are not copied onto this page.
Sources and dates
- ClinicalTrials.gov – the record this page reformats
- ClinicalTrials.gov processing date: 23 September 2026.
- This page last checked by Voxsanity: 11 October 2026.
Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.
Not medical advice.
Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.
Letter for your doctor
A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.