NCT07024732CompletedPhase 1
A Safety and Tolerability Clinical Trial of PST-611 in Dry Age-related Macular Degeneration
An Open-label Single Ascending Dose Safety and Tolerability Clinical Trial of PST-611 in Subjects With Dry Age-related Macular Degeneration
Source: ClinicalTrials.gov · Last updated 13 Jul 2026
Brief summary (registry, in English)
The goal of this interventional study is to evaluate the safety and tolerability of single ascending doses of PST-611 in men and women over the age of 50 with dry age-related macular degeneration (AMD). The main question it aims to answer is: Is PST-611-CT1 safe for participants? Participants will: * Receive a single dose of PST-611 * Will be followed up for a total of 16 weeks following PST-611 administration
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 8 (actual)
- First submitted
- 5 Jun 2025
- Start date
- 23 Jun 2025
- Primary completion date
- 7 Apr 2026
- Lead sponsor
- Eyevensys
- Diseases
- Macular degeneration
- NCT number
- NCT07024732
- EU CT number
- 2024-519025-37-00
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 8
- From 23 Jun 2025 to the primary completion date, 7 Apr 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- \- Both eyes: any active intraocular or periocular infection or inflammation (eg, infectious blepharitis, infectious conjunctivitis, keratitis, scleritis, endophthalmitis), or history of intraocular or periocular infection or inflammation in the 12 weeks (84 days) prior to the PST-611 administration.
- Study eye: Any intraocular surgery (including cataract surgery) or intravitreal (IVT) or periocular corticosteroid injection within 12 weeks (84 days) prior to the PST-611 administration.
- SE: Any anti-VEGF IVT treatment within 4 weeks (28 days) prior to PST-611 dosing OR subjects who have required and received regular monthly injections of anti-VEGF drugs in the months preceding the trial and would thus have a higher likelihood of requiring and anti-VEGF treatment within 28 days of the PST-611 administration.
- SE: media opacity that interferes with fundus imaging or is likely to require surgery during the trial period.
Other illness
- SE: subject with history of glaucoma filtering surgery (e.g. trabeculectomy or aqueous shunt implant) or who underwent eye surgery within 12 weeks (84 days) of the PST-611 administration.
Other
- SE: subject who has uncontrolled intraocular pressure of ≥ 25 mmHg in the SE at the screening and baseline visits.
Who the study is looking for
- must give written informed consent, be able to make the required trial visits and follow instructions.
- Female and male subjects 50 years of age or older.
- Female subjects of childbearing potential must not be pregnant or breast-feeding and must have a negative urine pregnancy test at baseline and throughout the study. They must agree to practice at least one effective method of birth control following administration of study medication.
- In the study eye (SE) : at least one of the following must be present at OCT and attributed to AMD, as evaluated by the Investigator: Incomplete RPE and Outer Retinal Atrophy (iRORA), or Complete RPE and Outer Retinal Atrophy (cRORA).
- In SE: BCVA must be 23 ETDRS letters (approximate Snellen equivalent 20/320) or better.
- In the fellow eye: BCVA must be 34 letters (approximate Snellen equivalent 20/200) or better.
Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Grenoble Alpes - Hôpital Michallon Coordinator of this site? Confirm its status | La Tronche | France | Active, not recruiting |
| Assistance Publique Hopitaux de Paris – Hopital Cochin Coordinator of this site? Confirm its status | Paris | France | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.