Health TrialsbyHealthPanel

A Safety and Tolerability Clinical Trial of PST-611 in Dry Age-related Macular Degeneration

ConditionDry Age Related Macular Degeneration
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age50+
SponsorEyevensys

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Sequential

Treatments tested in this trial

  • PST-611

    Biological/Vaccine

    PST-611 is a naked plasmid DNA encoding human transferrin administered into the ciliary muscle

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: Active treatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Safety and Tolerability

Ocular and non-ocular adverse events frequency and severity

Time frame
Screening to week 16

Secondary outcomes

1

Intraocular pressure

Intraocular pressure measured in mmHg

Time frame
Screening to Week 16
2

Best corrected visual acuity

Best corrected visual acuity measured in ETDRS letters

Time frame
Screening to Week 16
3

Slit lamp biomicroscopy examination

Abnormal examination results will be recorded

Time frame
Screening to Week 16
4

Dilated ophthalmoscopy examination

Abnormal examination results will be recorded

Time frame
Screening to Week 16

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eyevensys

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: