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| ID | Type | Description | Link |
|---|---|---|---|
| PRM151B-21GL | Other Identifier | Promedior, Inc. | |
| 2009-017859-98 | EudraCT Number |
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This study will assess the safety and tolerability of PRM-151 administered as a subconjunctival injection and explore the effect of PRM-151 on various correlates of the wound healing process that occurs in the eye after glaucoma filtration surgery.
Glaucoma is a disease of the eye which affects the optic nerve (the nerve that sends signals from the eye to the brain) and is associated with visual field defects and potential blindness. The treatment of glaucoma involves lowering the pressure in the eye, which is often (but not always) elevated due to accumulation of fluid inside the eye that cannot drain away. In the operation called trabeculectomy (a type of filtration surgery), a small channel is created through the sclera (the white of the eye) to allow accumulated fluid to drain away. Scarring may occur after surgery when, during healing, too much collagen (a type of protein) is deposited in the channel. This causes the channel to seal up and the pressure inside the eye to build up again.
The study will be conducted in patients suffering from glaucoma who are due to undergo trabeculectomy. Patients will be randomized to have either PRM-151 or placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRM-151 | Experimental | PRM-151 (recombinant human serum amyloid P, recombinant human pentraxin 2) |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRM-151 | Drug | PRM-151 2 milligrams (mg) (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of Subconjunctival Injection | 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 | AEs, slit-lamp, and fundoscopy findings from first injection through end of study; TEAEs from first injection through Day 30 |
| Subjects With Safety Related Events or Findings | The number of Subjects with AEs, TEAEs, SAEs, decreased visual acuity, and worsened visual fields | First injection through end of study for AEs, SAEs, visual acuity and visual fields, and from first injection through Day 30 for TEAEs |
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| Measure | Description | Time Frame |
|---|---|---|
| Successful Intra-ocular Pressure (IOP) Control | Exploratory efficacy outcome measure. Successful IOP control defined as IOP between 6 and 18 mm Hg or 25% reduction from pre-surgical IOP | Day 120 |
| Bleb Scarring |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Edelson, MD, FRCPC, MHSc | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Leuven | Leuven | B-3000 | Belgium | |||
| Oftalmologicka klinika Brno-Bohunice |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Placebo | Placebo Placebo: Placebo solution (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| All Study Treatment Days 1-9 |
| |||||||||||||
| Study Completion |
|
All subjects screened and enrolled in study
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Safety of Subconjunctival Injection | 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 | All subjects enrolled in study; all subjects received all study treatment | Posted | Number | Number of occurrences | AEs, slit-lamp, and fundoscopy findings from first injection through end of study; TEAEs from first injection through Day 30 |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intraocular pressure increased | Investigations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anterior chamber cell | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth G. Trehu, MD | Promedior, Inc. | 781-538-4203 | btrehu@promedior.com |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C552898 | PRM-151 |
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| Placebo | Drug | Placebo solution (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9 |
|
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.
| Day 120 |
| Brno |
| 639 00 |
| Czechia |
| Facility Hospital Hradec Kralove | Hradec Králové | 500 05 | Czechia |
| Palacky University | Olomouc | 775 20 | Czechia |
| Hospital Pardubice | Pardubice | 53203 | Czechia |
| Charles University | Prague | Czechia |
| Masaryak's Hospital | Ústà nad Labem | 40013 | Czechia |
| UMC St. Radboud West | Nijmegen | 6525 EX | Netherlands |
| Eramus Medical Center | Rotterdam | 3015 CE | Netherlands |
| Cheltenham General Hospital | Gloucestershire | GL53 7AN | United Kingdom |
| St. Thomas | London | United Kingdom |
| Norfolk and Norwich University Hospital-NHS Trust | Norwich | NR4 7UY | United Kingdom |
| Oxford Eye Hosiptal | Oxford | OX3 9DU | United Kingdom |
| Royal Hallamshire Hospital | Sheffield | S10 2JF | United Kingdom |
| NOT COMPLETED |
|
|
Placebo Placebo: Placebo solution (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Placebo |
Placebo Placebo: Placebo solution (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9 |
|
|
| Other Pre-specified | Successful Intra-ocular Pressure (IOP) Control | Exploratory efficacy outcome measure. Successful IOP control defined as IOP between 6 and 18 mm Hg or 25% reduction from pre-surgical IOP | Posted | Number | participants | Day 120 |
|
|
|
| Other Pre-specified | Bleb Scarring | 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. | Number of subjects who had assessment of bleb scarring on Day 120 | Posted | Mean | Standard Deviation | units on a scale | Day 120 |
|
|
|
| Primary | Subjects With Safety Related Events or Findings | The number of Subjects with AEs, TEAEs, SAEs, decreased visual acuity, and worsened visual fields | Posted | Number | participants | First injection through end of study for AEs, SAEs, visual acuity and visual fields, and from first injection through Day 30 for TEAEs |
|
|
|
| 9 |
| 62 |
| 44 |
| 62 |
| EG001 | Placebo | Placebo Placebo: Placebo solution (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9 | 6 | 62 | 41 | 62 |
| Glaucoma | Eye disorders | Systematic Assessment |
|
| Choroidal detachment | Eye disorders | Systematic Assessment |
|
| Choroidal effusion | Eye disorders | Systematic Assessment |
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| Flat Anterior Chamber of Eye | Eye disorders | Systematic Assessment |
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| Retinal vein occlusion | Eye disorders | Systematic Assessment |
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| Visual field defect | Nervous system disorders | Systematic Assessment |
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| Chronic Lymphocytic Leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Rectosigmoid cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Cerebrovascular disorder | Nervous system disorders | Systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Conjunctival haemorrhage | Eye disorders | Systematic Assessment |
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| Conjunctival hyperemia | Eye disorders | Systematic Assessment |
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| Flat anterior chamber of eye | Eye disorders | Systematic Assessment |
|
| Hyphaema | Eye disorders | Systematic Assessment |
|
| Anterior chamber flare | Eye disorders | Systematic Assessment |
|
| Retinal pigmentation | Eye disorders | Systematic Assessment |
|
| Intraocular pressure increased | Investigations | Systematic Assessment |
|
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| Subjects with at least 1 SAE |
|
| Subjects with decreased visual acuity |
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| Subjects with worsened visual field |
|