Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 10:26 PM
Study NCT ID:
NCT04060758
Status:
COMPLETED
Last Update Posted:
2025-11-20
First Post:
2019-08-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Open Label, Sequential-dose Study of PA5108 Latanoprost FA SR Ocular Implant for Mild-moderate Glaucoma
Sponsor:
PolyActiva Pty Ltd
Organization:
Study Overview
Official Title:
An Open Label, Comparative, Sequential-dose, Multi-centre Study Involving Intracameral Administration of a PA5108 Latanoprost FA SR Ocular Implant Into the Eye of Patients With Mild-moderate Glaucoma
Status:
COMPLETED
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed 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 single-dose cohorts will be assessed from the following implant strengths:
* 35.5 microgram
* 26.6 microgram
* 14.7 microgram
In addition, a repeat-dose cohort will be assessed from the following implant strength:
o 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 repeat-dosed with 14.7 mcg PA5108 Latanoprost FA SR Ocular Implant. A fourth cohort of participants will be recruited and dosed with the 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 enrolled in the single-dose cohorts 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 at Day 0. Whereas eligible participants enrolled in the repeat-dose cohort 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 at Day 0, and again at Week 21.
The study will end at the later of Visit 12 (48-weeks) for the last participant in the repeat dose cohort, 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 in the single dose cohorts 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 6, 12, optionally 15, 18, optionally 21, 26 \& 32, and if necessary, every 6-weeks thereafter.
Participants in the repeat dose cohort will attend the study site for follow up on Day 1 post implant administration, and then Week 6, 12,18, Week 21 (when they will be administered the second dose), Day 1 post repeat dose, Week 27, 33, 42, 48 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 6,12,18, 21,27, 33,42 \& 48, and if necessary, every 6-weeks thereafter.
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 single-dose cohorts will be assessed from the following implant strengths:
* 35.5 microgram
* 26.6 microgram
* 14.7 microgram
In addition, a repeat-dose cohort will be assessed from the following implant strength:
o 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 repeat-dosed with 14.7 mcg PA5108 Latanoprost FA SR Ocular Implant. A fourth cohort of participants will be recruited and dosed with the 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 enrolled in the single-dose cohorts 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 at Day 0. Whereas eligible participants enrolled in the repeat-dose cohort 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 at Day 0, and again at Week 21.
The study will end at the later of Visit 12 (48-weeks) for the last participant in the repeat dose cohort, 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 in the single dose cohorts 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 6, 12, optionally 15, 18, optionally 21, 26 \& 32, and if necessary, every 6-weeks thereafter.
Participants in the repeat dose cohort will attend the study site for follow up on Day 1 post implant administration, and then Week 6, 12,18, Week 21 (when they will be administered the second dose), Day 1 post repeat dose, Week 27, 33, 42, 48 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 6,12,18, 21,27, 33,42 \& 48, and if necessary, every 6-weeks thereafter.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: