Badanie bezpieczeństwa i tolerancji PST-611 u pacjentów z geograficzną atrofią plamki żółtej

Initial visit – baseline assessments

You attend the clinic after joining the study. During this visit a series of eye examinations are performed to record the condition before any treatment.

The examinations include a slit lamp check, a dilated eye view, measurement of intraocular pressure (pressure inside the eye), best corrected visual acuity (sharpness of vision), color fundus photography (photo of the back of the eye) and spectral domain‑optical coherence tomography (sd‑OCT – a detailed scan of eye layers).

The results are saved as the reference point for later comparison.

First administration of <b>pst‑611</b>

The study drug pst‑611 is given as an intraocular injection (injection into the eye).

The dose is 00 µg (microgram) of the solution for injection.

The injection is performed by a qualified eye doctor in a sterile setting.

Early safety follow‑up

Shortly after the first injection you return for a follow‑up visit. The same eye examinations as at baseline are repeated to check for any ocular adverse events (AE – side effects affecting the eye) or treatment‑emergent adverse events (teae – side effects that appear after receiving the drug).

Any serious adverse events (sae – side effects that require medical attention) are recorded.

Subsequent doses of <b>pst‑611</b>

Additional injections of pst‑611 are given according to the study schedule. Each dose is the same 00 µg intraocular injection.

Between doses you attend regular clinic visits where the same set of eye examinations is performed to monitor safety and tolerability.

Intermediate evaluations

Throughout the study period you undergo periodic assessments that include measurement of intraocular pressure, visual acuity, color fundus photography and sd‑OCT scans.

These evaluations allow the study team to observe any changes from the baseline values.

Final visit – end of study assessments

At the end of the trial you attend a final visit. The full set of eye examinations is repeated.

The results are compared with the baseline data to determine the overall safety, tolerability and exploratory efficacy of pst‑611.