Not provided
Not provided
Not provided
Not provided
Not provided
The study was terminated due to a company decision.
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Molecular Partners AG | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to assess the safety and tolerability of MP0112 (a novel, potentially long acting VEGF inhibitor) in patients with diabetic retinal edema.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MP0112 (0.04 mg) | Experimental | Single 0.04 mg intravitreal injection of MP0112 in the study eye. |
|
| MP0112 (0.15 mg) | Experimental | Single 0.15 mg intravitreal injection of MP0112 in the study eye. |
|
| MP0112 (0.4 mg) | Experimental | Single 0.4 mg intravitreal injection of MP0112 in the study eye. |
|
| MP0112 (1.0 mg) | Experimental | Single 1.0 mg intravitreal injection of MP0112 in the study eye. |
|
| MP0112 (2.0 mg) | Experimental | Single 2.0 mg intravitreal injection of MP0112 in the study eye. |
|
| MP0112 (3.6 mg) | Experimental | Single 3.6 mg intravitreal injection of MP0112 in the study eye. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MP0112 | Biological | Single intravitreal injection of MP0112 in the study eye |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability | Safety and tolerability was assessed by vital signs, clinical laboratory evaluations, ophthalmological examinations, intraocular pressure, the presence of anti-drug antibodies and the collection of adverse events. An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events. | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Best-Corrected Visual Acuity (BCVA) | BCVA was measured using an eye chart and was reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye at Baseline and Week 16. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the letters read correctly on the eye chart the better the vision. | Baseline, Week 16 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wilmer Eye Institute | Baltimore | Maryland | 21287 | United States | ||
| Ophthalmic Consultants of Boston |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | MP0112 (0.04 mg) | Single 0.04 mg intravitreal injection of MP0112 in the study eye. |
| FG001 | MP0112 (0.15 mg) | Single 0.15 mg intravitreal injection of MP0112 in the study eye. |
| FG002 | MP0112 (0.4 mg) | Single 0.4 mg intravitreal injection of MP0112 in the study eye. |
| FG003 | MP0112 (1.0 mg) | Single 1.0 mg intravitreal injection of MP0112 in the study eye. |
| FG004 | MP0112 (2.0 mg) | Single 2.0 mg intravitreal injection of MP0112 in the study eye. |
| FG005 | MP0112 (3.6 mg) | Single 3.6 mg intravitreal injection of MP0112 in the study eye. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | MP0112 (0.04 mg) | Single 0.04 mg intravitreal injection of MP0112 in the study eye. |
| BG001 | MP0112 (0.15 mg) | Single 0.15 mg intravitreal injection of MP0112 in the study eye. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants With Adverse Events as a Measure of Safety and Tolerability | Safety and tolerability was assessed by vital signs, clinical laboratory evaluations, ophthalmological examinations, intraocular pressure, the presence of anti-drug antibodies and the collection of adverse events. An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events. | All treated participants. | Posted | Number | Participants | 16 weeks |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MP0112 (0.04 mg) | Single 0.04 mg intravitreal injection of MP0112 in the study eye. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest pain | General disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
Not provided
| ID | Term |
|---|---|
| C581258 | MP0112 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Change From Baseline in Foveal Thickness as Measured by Optical Coherence Tomography (OCT) | Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the fovea (part of the retina), was performed in the study eye after pupil dilation at Baseline and Week 16. A negative change from Baseline indicated improvement (less foveal thickness). | Baseline, Week 16 |
| Serum Levels of MP0112 | Blood samples were collected Pre-treatment (Baseline), Day 1 and 3, Weeks 1, 4, 12, 16. Serum samples (liquid portion of the blood after cells and clotting factors were removed) were sent to a laboratory for analysis. Levels of MP0112 were determined using an enzyme-linked immunosorbent assay. | 16 Weeks |
| Aqueous Humor Levels of MP0112 | Aqueous humor (the thin, watery fluid in the eye) samples were collected from anterior chamber taps and were sent to a laboratory for analysis. Levels of MP0112 were determined using an enzyme-linked immunosorbent assay. | 1 Week |
| Number of Participants With Positive Binding Anti-MP0112 Antibodies | Blood samples were collected Pre-treatment (Baseline) and Weeks 4, 8 and 12. Samples were analyzed for Anti-MP0112 antibodies using an enzyme-linked immunosorbent assay. | 12 weeks |
| Boston |
| Massachusetts |
| 02114 |
| United States |
| Retina Research Center | Austin | Texas | 78705 | United States |
| Retina Consultants of Houston | Houston | Texas | 77030 | United States |
| BG002 | MP0112 (0.4 mg) | Single 0.4 mg intravitreal injection of MP0112 in the study eye. |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| MP0112 (0.15 mg) |
Single 0.15 mg intravitreal injection of MP0112 in the study eye. |
| OG002 | MP0112 (0.4 mg) | Single 0.4 mg intravitreal injection of MP0112 in the study eye. |
|
|
| Secondary | Best-Corrected Visual Acuity (BCVA) | BCVA was measured using an eye chart and was reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye at Baseline and Week 16. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the letters read correctly on the eye chart the better the vision. | All treated participants with data for a given time point were included for analysis. | Posted | Mean | Standard Deviation | Letters | Baseline, Week 16 |
|
|
|
| Secondary | Change From Baseline in Foveal Thickness as Measured by Optical Coherence Tomography (OCT) | Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the fovea (part of the retina), was performed in the study eye after pupil dilation at Baseline and Week 16. A negative change from Baseline indicated improvement (less foveal thickness). | All treated participants. | Posted | Mean | Standard Deviation | microns | Baseline, Week 16 |
|
|
|
| Secondary | Serum Levels of MP0112 | Blood samples were collected Pre-treatment (Baseline), Day 1 and 3, Weeks 1, 4, 12, 16. Serum samples (liquid portion of the blood after cells and clotting factors were removed) were sent to a laboratory for analysis. Levels of MP0112 were determined using an enzyme-linked immunosorbent assay. | All treated participants. | Posted | Median | Full Range | Nanomolar (nM) | 16 Weeks |
|
|
|
| Secondary | Aqueous Humor Levels of MP0112 | Aqueous humor (the thin, watery fluid in the eye) samples were collected from anterior chamber taps and were sent to a laboratory for analysis. Levels of MP0112 were determined using an enzyme-linked immunosorbent assay. | All treated participants who consented to participate. | Posted | Median | Full Range | nM | 1 Week |
|
|
|
| Secondary | Number of Participants With Positive Binding Anti-MP0112 Antibodies | Blood samples were collected Pre-treatment (Baseline) and Weeks 4, 8 and 12. Samples were analyzed for Anti-MP0112 antibodies using an enzyme-linked immunosorbent assay. | All treated participants. | Posted | Number | Participants | 12 weeks |
|
|
|
| 0 |
| 6 |
| 3 |
| 6 |
| EG001 | MP0112 (0.15 mg) | Single 0.15 mg intravitreal injection of MP0112 in the study eye. | 1 | 6 | 6 | 6 |
| EG002 | MP0112 (0.4 mg) | Single 0.4 mg intravitreal injection of MP0112 in the study eye. | 0 | 6 | 6 | 6 |
| Conjunctival haemorrhage | Eye disorders | Systematic Assessment |
|
| Foreign body sensation in eyes | Eye disorders | Non-systematic Assessment |
|
| Anterior chamber flare | Eye disorders | Systematic Assessment |
|
| Eye pain | Eye disorders | Non-systematic Assessment |
|
| Iritis | Eye disorders | Systematic Assessment |
|
| Conjunctival hyperaemia | Eye disorders | Systematic Assessment |
|
| Eye irritation | Eye disorders | Non-systematic Assessment |
|
| Anterior chamber cell | Eye disorders | Systematic Assessment |
|
| Blepharitis | Eye disorders | Systematic Assessment |
|
| Conjunctival oedema | Eye disorders | Systematic Assessment |
|
| Photophobia | Eye disorders | Systematic Assessment |
|
| Retinal exudates | Eye disorders | Systematic Assessment |
|
| Vitreal cells | Eye disorders | Systematic Assessment |
|
| Vitreous floaters | Eye disorders | Systematic Assessment |
|
| Vitritis | Eye disorders | Systematic Assessment |
|
| Diabetic retinal oedema | Eye disorders | Systematic Assessment |
|
| Diabetic retinopathy | Eye disorders | Systematic Assessment |
|
| Eye pruritus | Eye disorders | Systematic Assessment |
|
| Iris adhesions | Eye disorders | Systematic Assessment |
|
| Iris atrophy | Eye disorders | Systematic Assessment |
|
| Lenticular pigmentation | Eye disorders | Systematic Assessment |
|
| Macular oedema | Eye disorders | Systematic Assessment |
|
| Ocular discomfort | Eye disorders | Non-systematic Assessment |
|
| Photopsia | Eye disorders | Systematic Assessment |
|
| Punctate keratitis | Eye disorders | Systematic Assessment |
|
| Retinal cyst | Eye disorders | Systematic Assessment |
|
| Retinal ischaemia | Eye disorders | Systematic Assessment |
|
| Retinal neovascularisation | Eye disorders | Systematic Assessment |
|
| Retinal pigment epitheliopathy | Eye disorders | Systematic Assessment |
|
| Vision blurred | Eye disorders | Systematic Assessment |
|
| Vitreous detachment | Eye disorders | Systematic Assessment |
|
| Vitreous fibrin | Eye disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
|
| Periodontal disease | Gastrointestinal disorders | Systematic Assessment |
|
| Chest pain | General disorders | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Systematic Assessment |
|
| Cellulitis | Infections and infestations | Systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | Systematic Assessment |
|
| Glycosylated haemoglobin increased | Investigations | Systematic Assessment |
|
| Paracentesis eye | Investigations | Systematic Assessment |
|
| Protein urine present | Investigations | Systematic Assessment |
|
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | Systematic Assessment |
|
| Osteopenia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Skin mass | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Hypertension | Vascular disorders | Systematic Assessment |
|
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
|
|