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The study was terminated due to a company decision following completion of Part A.
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| Name | Class |
|---|---|
| Molecular Partners AG | INDUSTRY |
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The purpose of this study is to assess the safety and tolerability of MP0112 (a novel, potentially long acting VEGF inhibitor) in patients with wet Age Related Macular Degeneration.
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| 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 |
|---|---|---|
| Maximal Tolerated Dose (MTD) Following a Single Injection | MTD was defined as one dose level below the lower of the dose level in which a severe (sight-threatening) drug-related Adverse Event occurred or the dose level at which more than 2 patients experienced a moderate ocular (eye) drug-related toxicity. | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Stable or Improved 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 4. 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. Stable or Improved BCVA was defined as a loss of <15 letters read correctly compared to Baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fakultni Nemocnice Brno | Brno | Czech | 62500 | Czechia | ||
| Fakultni Nemocnice Olomouc |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24907435 | Derived | Souied EH, Devin F, Mauget-Faysse M, Kolar P, Wolf-Schnurrbusch U, Framme C, Gaucher D, Querques G, Stumpp MT, Wolf S; MP0112 Study Group. Treatment of exudative age-related macular degeneration with a designed ankyrin repeat protein that binds vascular endothelial growth factor: a phase I/II study. Am J Ophthalmol. 2014 Oct;158(4):724-732.e2. doi: 10.1016/j.ajo.2014.05.037. Epub 2014 Jun 5. |
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| 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 |
|
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| 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 | Maximal Tolerated Dose (MTD) Following a Single Injection | MTD was defined as one dose level below the lower of the dose level in which a severe (sight-threatening) drug-related Adverse Event occurred or the dose level at which more than 2 patients experienced a moderate ocular (eye) drug-related toxicity. | All treated participants. | Posted | Number | mg | 16 weeks |
|
|
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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 | 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 |
|---|---|---|---|---|---|
| Endophthalmitis | Infections and infestations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ventricular fibrillation | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
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| ID | Term |
|---|---|
| C581258 | MP0112 |
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|
| Baseline, Week 4 |
| Change From Baseline in Central Area Retinal Thickness | Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed in the study eye after pupil dilation at Baseline and Week 4. A negative change from Baseline indicated improvement (less retinal thickness). A positive change from Baseline indicated worsening (definite retinal thickening). | Baseline, Week 4 |
| Area of Leakage as Measured by Fluorescein Angiography | Fluorescein angiography (FA) is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. Photographs are taken with a specialized low-power microscope with an attached camera designed to photograph the interior of the eye, including the retina and optic disc. FA was performed on the dilated study eye 10 minutes after fluorescein application at Baseline and Week 4. A lower number indicated a smaller area of leakage. | Baseline, Week 4 |
| Area of Lesion as Measured by Fluorescein Angiography | Fluorescein angiography (FA) is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. Photographs are taken with a specialized low-power microscope with an attached camera designed to photograph the interior of the eye, including the retina and optic disc. FA was performed on the dilated study eye after fluorescein application at Baseline and Week 4. A lower number indicated a smaller lesion area. | Baseline, Week 4 |
| Maximum Serum Concentration (Cmax) of MP0112 at Day 3 | Blood samples were collected for MP0112 levels on Day 3. The serum samples (liquid portion of the blood after cells and clotting factors were removed) were sent to a laboratory and were analyzed for MP0112 levels using an enzyme-linked immunosorbent assay. Maximum concentration at Day 3 was calculated. | Day 3 |
| 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 |
| Olomouc |
| Czech |
| 77520 |
| Czechia |
| Ustrendi Vojenska Nemocnice | Prague | Czech | 16902 | Czechia |
| Hopital Intercommunual de Creteil | Créteil | Creteil | 94010 | France |
| Centre Rabelais | Lyon | Lyon | 69003 | France |
| Centre Paradis-Monticelli | Marseille | Marseille | 13008 | France |
| Hopitaux Universitaires | Strasbourg | Strasbourg | 67091 | France |
| Inselspital | Bern | Canton of Bern | CH-3010 | Switzerland |
| BG002 | MP0112 (0.4 mg) | Single 0.4 mg intravitreal injection of MP0112 in the study eye. |
| BG003 | MP0112 (1.0 mg) | Single 1.0 mg intravitreal injection of MP0112 in the study eye. |
| BG004 | MP0112 (2.0 mg) | Single 2.0 mg intravitreal injection of MP0112 in the study eye. |
| BG005 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Percentage of Participants With Stable or Improved 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 4. 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. Stable or Improved BCVA was defined as a loss of <15 letters read correctly compared to Baseline. | All treated participants. | Posted | Number | Percentage of participants | Baseline, Week 4 |
|
|
|
| Secondary | Change From Baseline in Central Area Retinal Thickness | Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed in the study eye after pupil dilation at Baseline and Week 4. A negative change from Baseline indicated improvement (less retinal thickness). A positive change from Baseline indicated worsening (definite retinal thickening). | All treated participants. | Posted | Mean | Standard Deviation | μm | Baseline, Week 4 |
|
|
|
| Secondary | Area of Leakage as Measured by Fluorescein Angiography | Fluorescein angiography (FA) is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. Photographs are taken with a specialized low-power microscope with an attached camera designed to photograph the interior of the eye, including the retina and optic disc. FA was performed on the dilated study eye 10 minutes after fluorescein application at Baseline and Week 4. A lower number indicated a smaller area of leakage. | All treated participants. | Posted | Mean | Standard Deviation | mm^2 | Baseline, Week 4 |
|
|
|
| Secondary | Area of Lesion as Measured by Fluorescein Angiography | Fluorescein angiography (FA) is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. Photographs are taken with a specialized low-power microscope with an attached camera designed to photograph the interior of the eye, including the retina and optic disc. FA was performed on the dilated study eye after fluorescein application at Baseline and Week 4. A lower number indicated a smaller lesion area. | All treated participants with data available for analysis. | Posted | Mean | Standard Deviation | mm^2 | Baseline, Week 4 |
|
|
|
| Secondary | Maximum Serum Concentration (Cmax) of MP0112 at Day 3 | Blood samples were collected for MP0112 levels on Day 3. The serum samples (liquid portion of the blood after cells and clotting factors were removed) were sent to a laboratory and were analyzed for MP0112 levels using an enzyme-linked immunosorbent assay. Maximum concentration at Day 3 was calculated. | Pharmacokinetic (PK) Population included all treated participants with PK data. | Posted | Number | Nanomolar (nM) | Day 3 |
|
|
|
| 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. | Safety Population included all treated participants. | Posted | Number | Participants | 12 weeks |
|
|
|
| 0 |
| 9 |
| 8 |
| 9 |
| EG001 | MP0112 (0.15 mg) | Single 0.15 mg intravitreal injection of MP0112 in the study eye. | 0 | 7 | 7 | 7 |
| EG002 | MP0112 (0.4 mg) | Single 0.4 mg intravitreal injection of MP0112 in the study eye. | 0 | 6 | 6 | 6 |
| EG003 | MP0112 (1.0 mg) | Single 1.0 mg intravitreal injection of MP0112 in the study eye. | 0 | 6 | 4 | 6 |
| EG004 | MP0112 (2.0 mg) | Single 2.0 mg intravitreal injection of MP0112 in the study eye. | 1 | 4 | 4 | 4 |
| Macular degeneration | Eye disorders | Systematic Assessment |
|
| Anterior chamber inflammation | Eye disorders | Systematic Assessment |
|
| Anterior chamber cell | Eye disorders | Systematic Assessment |
|
| Cataract | Eye disorders | Systematic Assessment |
|
| Conjunctival haemorrhage | Eye disorders | Systematic Assessment |
|
| Corneal epithelium defect | Eye disorders | Systematic Assessment |
|
| Detachment of retinal pigment epithelium | Eye disorders | Systematic Assessment |
|
| Eye pain | Eye disorders | Non-systematic Assessment |
|
| Iridocyclitis | Eye disorders | Systematic Assessment |
|
| Macular cyst | Eye disorders | Systematic Assessment |
|
| Macular oedema | Eye disorders | Systematic Assessment |
|
| Ocular toxicity | Eye disorders | Systematic Assessment |
|
| Pseudoendophthalmitis | Eye disorders | Systematic Assessment |
|
| Retinal haemorrhage | Eye disorders | Systematic Assessment |
|
| Retinal neovascularisation | Eye disorders | Systematic Assessment |
|
| Retinal oedema | Eye disorders | Systematic Assessment |
|
| Subretinal fibrosis | Eye disorders | Systematic Assessment |
|
| Uveitis | Eye disorders | Systematic Assessment |
|
| Vitreal cells | Eye disorders | Systematic Assessment |
|
| Vitreous detachment | Eye disorders | Systematic Assessment |
|
| Vitreous opacities | Eye disorders | Systematic Assessment |
|
| Chest pain | General disorders | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Systematic Assessment |
|
| Blood pressure increased | Investigations | Systematic Assessment |
|
| Intraocular pressure decreased | Investigations | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | Systematic Assessment |
|
| Vitritis | Eye disorders | Systematic Assessment |
|
| Endophthalmitis | Infections and infestations | 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.
| Change from Baseline at Week 4 |
|
| Week 4 (n=9,7,6,6,3) |
|
| Week 4 (n=9,6,6,6,2) |
|