Open Label Sequential-dose Study of PA5108 Latanoprost FA SR Ocular Implant for Mild-moderate Glaucoma

  • STATUS
    Recruiting
  • days left to enroll
    8
  • participants needed
    30
  • sponsor
    PolyActiva Pty Ltd
Updated on 7 May 2021
retinopathy
diabetic retinopathy
corrected visual acuity
brimonidine tartrate ophthalmic solution
latanoprost
primary open angle glaucoma

Summary

This is a multi-centre, open label, interventional, comparative, phase I study to identify a safe and efficacious dose (within the range of 14.7mcg to 35.5 mcg) of PA5108 (PolyActiva product code) Latanoprost free acid (FA) sustained release (SR) Ocular Implant in adults who have Primary Open Angle Glaucoma.

Description

This is a multi-centre, open label, interventional, comparative, phase Ib dose ranging study to identify a safe and efficacious dose (within the range of 14.7 to 35.5 microgram) of PA5108 Latanoprost FA SR Ocular Implant in adults who have Primary Open Angle Glaucoma (POAG).

The proposed study is a single ascending dose design to determine the minimum effective dose that provides the target of >20% IOP lowering effect at 12 weeks with minimal adverse events.

Up to three cohorts will be assessed from the following implant strengths:

  • 35.5 microgram
  • 26.6 microgram
  • 14.7 microgram

A first cohort of participants will be recruited and dosed with the 14.7 mcg PA5108 Latanoprost FA SR Ocular Implant. A second cohort of participants will be recruited after SMC review of 6-week data of the first cohort and dosed with the 26.6 mcg PA5108 Latanoprost FA SR Ocular Implant. A third cohort of participants will be recruited after SMC review of 6-week data of the second cohort and dosed with 35.5 mcg PA5108 Latanoprost FA SR Ocular Implant.

Prior to study registration, participants will have been medicated with intraocular pressure (IOP) lowering drop therapy, including a prostaglandin analogue, to manage their POAG. The IOP lowering drops will be stopped in the intent to treat eye within 29 to 43 days prior to the date of implant administration. Participants will be required to have an unmedicated (post wash-out) 8:00am IOP 24 mmHg and 36mmHg in the intent to treat eye at either of two screening visits 2-weeks apart. Additionally, the IOP at 12:00 noon and 4:00 pm must be 20mmHg and 36mmHg on the same screening visit where the 8:00am IOP was 24 mmHg and 36mmHg.

The PA5108 Latanoprost FA SR Ocular Implant will be administered to one eye (unilateral) of each participant.

IOP will be monitored and if after implant administration is found to rise 30% over baseline in the study eye, IOP lowering eye drops will be restarted.

The study will recruit up to 10 participants per cohort/dose level. After screening, eligible participants will be administered a single PA5108 Latanoprost FA SR Ocular Implant by clear corneal injection to the anterior chamber of the eye, by means of a custom-built injector fitted with a 27G pre-loaded needle.

The study will end at the later of Visit 7 (32-weeks) for the last participant in the study, or when the last of the study implants are no longer visible in the study eye and the IOP in the same eye has returned to a normal clinical care range, or 12-weeks has passed since the implant was no longer visible regardless of IOP.

Participants will attend the study site for follow up on Day 1 post implant administration, and then Week 6, 12, (optionally 15), 18, (optionally 21), 26, 32 and if required subsequent 6-week intervals until the implant has completely biodegraded and the IOP of the same eye has returned to normal clinical care range or 12-weeks has passed since the implant was no longer visible. Implant biodegradation will be confirmed by biomicroscopy and gonioscopy examination at Week 12, optionally 15, 18, optionally 21, 26 & 32, and if necessary, every 6-weeks thereafter.

Details
Condition Glaucoma, Pigmentary glaucoma, Open Angle Glaucoma
Treatment PA5108 Latanoprost FA SR Ocular Implant
Clinical Study IdentifierNCT04060758
SponsorPolyActiva Pty Ltd
Last Modified on7 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Participants who
Diagnosis of primary open angle glaucoma
Unmedicated 8:00am IOP 24 mmHg and 36mmHg in the intent to treat eye. Additionally, the IOP at 12:00 and 16:00 hrs must be 20mmHg and 36mmHg
Corrected visual acuity in each eye greater than or equal to +0.3logMAR
Minimum central endothelial cell density of greater than or equal to 1600 cells per mm2
Currently managing their POAG with IOP lowering drop therapy

Exclusion Criteria

Participants who
Have pseudoexfoliation or pigment dispersion component, history of angle closure, or narrow angles
Have a history of or current ocular inflammation
Have aphakic eyes or only one eye
Recent surgery in the study eye surgery (including laser)
Clinically significant ocular disease in either eye (e.g., corneal oedema, uveitis, severe keratoconjunctivitis sicca or infection) which might interfere with the study
Known sensitivity to any component of the product (e.g. latanoprost or polytriazole sensitivity), or to topical therapy used during course of study (e.g. povidone iodine, or anaesthetics)
Ocular medication in either eye of any kind within 30 days of screening
Central corneal thickness in either eye that is less than 470 m or greater than 630 m at screening (or a difference between the eyes >70 m)
Any abnormality in either eye preventing reliable applanation tonometry, including aphakic eyes or significant corneal guttatae
Any other clinically significant disease (as determined by physician) which might interfere with the study
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note