Trial Outcomes & Findings for PRM-151 in the Prevention of Scarring Following Trabeculectomy (NCT NCT01064817)

Last Updated: 2022-04-28

Results Overview

Number of adverse events (AEs), treatment emergent adverse events (TEAEs), non-ocular TEAEs, Ocular TEAEs, serious adverse events (SAEs), abnormal slit-lamp biomicroscopic findings, and abnormal dilated fundoscopy findings

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

124 participants

Primary outcome timeframe

AEs, slit-lamp, and fundoscopy findings from first injection through end of study; TEAEs from first injection through Day 30

Results posted on

2022-04-28

Participant Flow

Participant milestones

Participant milestones
Measure	PRM-151 PRM-151 (recombinant human serum amyloid P, recombinant human pentraxin 2) PRM-151: PRM-151 2 milligrams (mg) (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9	Placebo Placebo Placebo: Placebo solution (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9
All Study Treatment Days 1-9 STARTED	62	62
All Study Treatment Days 1-9 COMPLETED	62	62
All Study Treatment Days 1-9 NOT COMPLETED	0	0
Study Completion STARTED	62	62
Study Completion COMPLETED	60	62
Study Completion NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	PRM-151 PRM-151 (recombinant human serum amyloid P, recombinant human pentraxin 2) PRM-151: PRM-151 2 milligrams (mg) (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9	Placebo Placebo Placebo: Placebo solution (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9
Study Completion Physician Decision	1	0
Study Completion Withdrawal by Subject	1	0

Baseline Characteristics

PRM-151 in the Prevention of Scarring Following Trabeculectomy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PRM-151 n=62 Participants PRM-151 (recombinant human serum amyloid P, recombinant human pentraxin 2) PRM-151: PRM-151 2 milligrams (mg) (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9	Placebo n=62 Participants Placebo Placebo: Placebo solution (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9	Total n=124 Participants Total of all reporting groups
Age, Continuous	65 years n=5 Participants	68 years n=7 Participants	66 years n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	32 Participants n=7 Participants	54 Participants n=5 Participants
Sex: Female, Male Male	40 Participants n=5 Participants	30 Participants n=7 Participants	70 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) White	58 Participants n=5 Participants	59 Participants n=7 Participants	117 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	59 Participants n=5 Participants	61 Participants n=7 Participants	120 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Czech Republic	34 participants n=5 Participants	39 participants n=7 Participants	73 participants n=5 Participants
Region of Enrollment Belgium	5 participants n=5 Participants	9 participants n=7 Participants	14 participants n=5 Participants
Region of Enrollment Netherlands	4 participants n=5 Participants	3 participants n=7 Participants	7 participants n=5 Participants
Region of Enrollment United Kingdom	19 participants n=5 Participants	11 participants n=7 Participants	30 participants n=5 Participants

PRIMARY outcome

Timeframe: AEs, slit-lamp, and fundoscopy findings from first injection through end of study; TEAEs from first injection through Day 30

Population: All subjects enrolled in study; all subjects received all study treatment

Outcome measures

Outcome measures
Measure	PRM-151 n=62 Participants PRM-151 (recombinant human serum amyloid P, recombinant human pentraxin 2) PRM-151: PRM-151 2 milligrams (mg) (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9	Placebo n=62 Participants Placebo Placebo: Placebo solution (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9
Safety of Subconjunctival Injection Number of AEs	274 Number of occurrences	220 Number of occurrences
Safety of Subconjunctival Injection Number of TEAEs	166 Number of occurrences	113 Number of occurrences
Safety of Subconjunctival Injection Number of Non-ocular TEAEs	16 Number of occurrences	11 Number of occurrences
Safety of Subconjunctival Injection Number of Ocular TEAEs	150 Number of occurrences	102 Number of occurrences
Safety of Subconjunctival Injection Number of SAEs	16 Number of occurrences	7 Number of occurrences
Safety of Subconjunctival Injection Number of abnormal slit-lamp findings	58 Number of occurrences	108 Number of occurrences
Safety of Subconjunctival Injection Number of abnormal optic nerve findings	284 Number of occurrences	290 Number of occurrences
Safety of Subconjunctival Injection Number of abnormal retina findings	18 Number of occurrences	39 Number of occurrences
Safety of Subconjunctival Injection Number of abnormal macula findings	2 Number of occurrences	4 Number of occurrences
Safety of Subconjunctival Injection Number of abnormal choroid findings	0 Number of occurrences	1 Number of occurrences

PRIMARY outcome

Timeframe: First injection through end of study for AEs, SAEs, visual acuity and visual fields, and from first injection through Day 30 for TEAEs

The number of Subjects with AEs, TEAEs, SAEs, decreased visual acuity, and worsened visual fields

Outcome measures

Outcome measures
Measure	PRM-151 n=62 Participants PRM-151 (recombinant human serum amyloid P, recombinant human pentraxin 2) PRM-151: PRM-151 2 milligrams (mg) (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9	Placebo n=62 Participants Placebo Placebo: Placebo solution (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9
Subjects With Safety Related Events or Findings Subjects with at least 1 AE	46 participants	47 participants
Subjects With Safety Related Events or Findings Subjects with at least 1 Treatment Emergent AE	44 participants	41 participants
Subjects With Safety Related Events or Findings Subjects with at least 1 SAE	9 participants	6 participants
Subjects With Safety Related Events or Findings Subjects with decreased visual acuity	0 participants	0 participants
Subjects With Safety Related Events or Findings Subjects with worsened visual field	5 participants	5 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 120

Exploratory efficacy outcome measure. Successful IOP control defined as IOP between 6 and 18 mm Hg or 25% reduction from pre-surgical IOP

Outcome measures

Outcome measures
Measure	PRM-151 n=62 Participants PRM-151 (recombinant human serum amyloid P, recombinant human pentraxin 2) PRM-151: PRM-151 2 milligrams (mg) (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9	Placebo n=62 Participants Placebo Placebo: Placebo solution (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9
Successful Intra-ocular Pressure (IOP) Control	36 participants	46 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 120

Population: Number of subjects who had assessment of bleb scarring on Day 120

Exploratory Efficacy Outcome measure: Bleb scarring is graded on a scale from 0-3. 0= none to minimal scarring, 1= mild, 2= moderate, 3= severe scarring.

Outcome measures

Outcome measures
Measure	PRM-151 n=46 Participants PRM-151 (recombinant human serum amyloid P, recombinant human pentraxin 2) PRM-151: PRM-151 2 milligrams (mg) (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9	Placebo n=54 Participants Placebo Placebo: Placebo solution (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9
Bleb Scarring	1.29 units on a scale Standard Deviation 0.663	1.30 units on a scale Standard Deviation 0.633

Adverse Events

PRM-151

Serious events: 9 serious events

Other events: 44 other events

Deaths: 0 deaths

Placebo

Serious events: 6 serious events

Other events: 41 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	PRM-151 n=62 participants at risk PRM-151 (recombinant human serum amyloid P, recombinant human pentraxin 2) PRM-151: PRM-151 2 milligrams (mg) (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9	Placebo n=62 participants at risk Placebo Placebo: Placebo solution (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9
Eye disorders Anterior chamber cell	17.7% 11/62 • SAEs are reported for all subjects from first study treatment injection through end of study (51 weeks). Treatment emergent adverse events are reported as defined in the protocol for all subjects from first study treatment injection through Day 30.	17.7% 11/62 • SAEs are reported for all subjects from first study treatment injection through end of study (51 weeks). Treatment emergent adverse events are reported as defined in the protocol for all subjects from first study treatment injection through Day 30.
Eye disorders Conjunctival haemorrhage	16.1% 10/62 • SAEs are reported for all subjects from first study treatment injection through end of study (51 weeks). Treatment emergent adverse events are reported as defined in the protocol for all subjects from first study treatment injection through Day 30.	8.1% 5/62 • SAEs are reported for all subjects from first study treatment injection through end of study (51 weeks). Treatment emergent adverse events are reported as defined in the protocol for all subjects from first study treatment injection through Day 30.
Eye disorders Conjunctival hyperemia	14.5% 9/62 • SAEs are reported for all subjects from first study treatment injection through end of study (51 weeks). Treatment emergent adverse events are reported as defined in the protocol for all subjects from first study treatment injection through Day 30.	6.5% 4/62 • SAEs are reported for all subjects from first study treatment injection through end of study (51 weeks). Treatment emergent adverse events are reported as defined in the protocol for all subjects from first study treatment injection through Day 30.
Eye disorders Flat anterior chamber of eye	9.7% 6/62 • SAEs are reported for all subjects from first study treatment injection through end of study (51 weeks). Treatment emergent adverse events are reported as defined in the protocol for all subjects from first study treatment injection through Day 30.	8.1% 5/62 • SAEs are reported for all subjects from first study treatment injection through end of study (51 weeks). Treatment emergent adverse events are reported as defined in the protocol for all subjects from first study treatment injection through Day 30.
Eye disorders Hyphaema	11.3% 7/62 • SAEs are reported for all subjects from first study treatment injection through end of study (51 weeks). Treatment emergent adverse events are reported as defined in the protocol for all subjects from first study treatment injection through Day 30.	4.8% 3/62 • SAEs are reported for all subjects from first study treatment injection through end of study (51 weeks). Treatment emergent adverse events are reported as defined in the protocol for all subjects from first study treatment injection through Day 30.
Eye disorders Anterior chamber flare	9.7% 6/62 • SAEs are reported for all subjects from first study treatment injection through end of study (51 weeks). Treatment emergent adverse events are reported as defined in the protocol for all subjects from first study treatment injection through Day 30.	3.2% 2/62 • SAEs are reported for all subjects from first study treatment injection through end of study (51 weeks). Treatment emergent adverse events are reported as defined in the protocol for all subjects from first study treatment injection through Day 30.
Eye disorders Retinal pigmentation	8.1% 5/62 • SAEs are reported for all subjects from first study treatment injection through end of study (51 weeks). Treatment emergent adverse events are reported as defined in the protocol for all subjects from first study treatment injection through Day 30.	3.2% 2/62 • SAEs are reported for all subjects from first study treatment injection through end of study (51 weeks). Treatment emergent adverse events are reported as defined in the protocol for all subjects from first study treatment injection through Day 30.
Investigations Intraocular pressure increased	27.4% 17/62 • SAEs are reported for all subjects from first study treatment injection through end of study (51 weeks). Treatment emergent adverse events are reported as defined in the protocol for all subjects from first study treatment injection through Day 30.	21.0% 13/62 • SAEs are reported for all subjects from first study treatment injection through end of study (51 weeks). Treatment emergent adverse events are reported as defined in the protocol for all subjects from first study treatment injection through Day 30.

Additional Information

Elizabeth G. Trehu, MD

Promedior, Inc.

Phone: 781-538-4203

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60