ClinicalTrials.gov
ClinicalTrials.gov Menu

PRM-151 in the Prevention of Scarring Following Trabeculectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01064817
Recruitment Status : Completed
First Posted : February 8, 2010
Results First Posted : August 7, 2014
Last Update Posted : August 7, 2014
Sponsor:
Information provided by (Responsible Party):
Promedior, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Glaucoma
Interventions Drug: PRM-151
Drug: Placebo
Enrollment 124
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PRM-151 Placebo
Hide Arm/Group Description

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 solution (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9

Period Title: All Study Treatment Days 1-9
Started 62 62
Completed 62 62
Not Completed 0 0
Period Title: Study Completion
Started 62 62
Completed 60 62
Not Completed 2 0
Reason Not Completed
Physician Decision             1             0
Withdrawal by Subject             1             0
Arm/Group Title PRM-151 Placebo Total
Hide Arm/Group Description

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 solution (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9

Total of all reporting groups
Overall Number of Baseline Participants 62 62 124
Hide Baseline Analysis Population Description
All subjects screened and enrolled in study
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 62 participants 62 participants 124 participants
65
(35 to 83)
68
(39 to 87)
66
(35 to 87)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants 62 participants 124 participants
Female
22
  35.5%
32
  51.6%
54
  43.5%
Male
40
  64.5%
30
  48.4%
70
  56.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants 62 participants 124 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
4
   6.5%
3
   4.8%
7
   5.6%
White
58
  93.5%
59
  95.2%
117
  94.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants 62 participants 124 participants
Hispanic or Latino
3
   4.8%
1
   1.6%
4
   3.2%
Not Hispanic or Latino
59
  95.2%
61
  98.4%
120
  96.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 62 participants 62 participants 124 participants
Czech Republic 34 39 73
Belgium 5 9 14
Netherlands 4 3 7
United Kingdom 19 11 30
1.Primary Outcome
Title Safety of Subconjunctival Injection
Hide Description 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
Time Frame AEs, slit-lamp, and fundoscopy findings from first injection through end of study; TEAEs from first injection through Day 30
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All subjects enrolled in study; all subjects received all study treatment
Arm/Group Title PRM-151 Placebo
Hide Arm/Group Description:

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 solution (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9

Overall Number of Participants Analyzed 62 62
Measure Type: Number
Unit of Measure: Number of occurrences
Number of AEs 274 220
Number of TEAEs 166 113
Number of Non-ocular TEAEs 16 11
Number of Ocular TEAEs 150 102
Number of SAEs 16 7
Number of abnormal slit-lamp findings 58 108
Number of abnormal optic nerve findings 284 290
Number of abnormal retina findings 18 39
Number of abnormal macula findings 2 4
Number of abnormal choroid findings 0 1
2.Primary Outcome
Title Subjects With Safety Related Events or Findings
Hide Description The number of Subjects with AEs, TEAEs, SAEs, decreased visual acuity, and worsened visual fields
Time Frame First injection through end of study for AEs, SAEs, visual acuity and visual fields, and from first injection through Day 30 for TEAEs
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PRM-151 Placebo
Hide Arm/Group Description:

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 solution (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9

Overall Number of Participants Analyzed 62 62
Measure Type: Number
Unit of Measure: participants
Subjects with at least 1 AE 46 47
Subjects with at least 1 Treatment Emergent AE 44 41
Subjects with at least 1 SAE 9 6
Subjects with decreased visual acuity 0 0
Subjects with worsened visual field 5 5
3.Other Pre-specified Outcome
Title Successful Intra-ocular Pressure (IOP) Control
Hide Description Exploratory efficacy outcome measure. Successful IOP control defined as IOP between 6 and 18 mm Hg or 25% reduction from pre-surgical IOP
Time Frame Day 120
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PRM-151 Placebo
Hide Arm/Group Description:

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 solution (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9

Overall Number of Participants Analyzed 62 62
Measure Type: Number
Unit of Measure: participants
36 46
4.Other Pre-specified Outcome
Title Bleb Scarring
Hide Description 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.
Time Frame Day 120
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number of subjects who had assessment of bleb scarring on Day 120
Arm/Group Title PRM-151 Placebo
Hide Arm/Group Description:

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 solution (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9

Overall Number of Participants Analyzed 46 54
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.29  (0.663) 1.30  (0.633)
Time Frame 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.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PRM-151 Placebo
Hide Arm/Group Description

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 solution (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9

All-Cause Mortality
PRM-151 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
PRM-151 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   9/62 (14.52%)   6/62 (9.68%) 
Cardiac disorders     
Myocardial infarction   1/62 (1.61%)  0/62 (0.00%) 
Eye disorders     
Glaucoma   1/62 (1.61%)  1/62 (1.61%) 
Choroidal detachment   1/62 (1.61%)  0/62 (0.00%) 
Choroidal effusion   0/62 (0.00%)  1/62 (1.61%) 
Flat Anterior Chamber of Eye   1/62 (1.61%)  0/62 (0.00%) 
Retinal vein occlusion   1/62 (1.61%)  0/62 (0.00%) 
Gastrointestinal disorders     
Abdominal pain   1/62 (1.61%)  0/62 (0.00%) 
Pancreatitis   1/62 (1.61%)  0/62 (0.00%) 
Vomiting   1/62 (1.61%)  0/62 (0.00%) 
Investigations     
Intraocular pressure increased   2/62 (3.23%)  4/62 (6.45%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Chronic Lymphocytic Leukaemia   1/62 (1.61%)  0/62 (0.00%) 
Rectosigmoid cancer recurrent   0/62 (0.00%)  1/62 (1.61%) 
Nervous system disorders     
Visual field defect   1/62 (1.61%)  0/62 (0.00%) 
Cerebrovascular disorder   1/62 (1.61%)  0/62 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease   1/62 (1.61%)  0/62 (0.00%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PRM-151 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   44/62 (70.97%)   41/62 (66.13%) 
Eye disorders     
Anterior chamber cell   11/62 (17.74%)  11/62 (17.74%) 
Conjunctival haemorrhage   10/62 (16.13%)  5/62 (8.06%) 
Conjunctival hyperemia   9/62 (14.52%)  4/62 (6.45%) 
Flat anterior chamber of eye   6/62 (9.68%)  5/62 (8.06%) 
Hyphaema   7/62 (11.29%)  3/62 (4.84%) 
Anterior chamber flare   6/62 (9.68%)  2/62 (3.23%) 
Retinal pigmentation   5/62 (8.06%)  2/62 (3.23%) 
Investigations     
Intraocular pressure increased   17/62 (27.42%)  13/62 (20.97%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Elizabeth G. Trehu, MD
Organization: Promedior, Inc.
Phone: 781-538-4203
Responsible Party: Promedior, Inc.
ClinicalTrials.gov Identifier: NCT01064817     History of Changes
Other Study ID Numbers: PRM151B-21GL
First Submitted: February 5, 2010
First Posted: February 8, 2010
Results First Submitted: April 14, 2014
Results First Posted: August 7, 2014
Last Update Posted: August 7, 2014