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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Single intravitreal injection of MP0112 in the study eye.
Fakultni Nemocnice Brno
Brno, Czech, Czechia
Fakultni Nemocnice Olomouc
Olomouc, Czech, Czechia
Ustrendi Vojenska Nemocnice
Prague, Czech, Czechia
Hopital Intercommunual de Creteil
Créteil, Creteil, France
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.
Time frame: 16 weeks
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.
Time frame: 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).
Time frame: 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.
Time frame: Baseline, Week 4
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Centre Rabelais
Lyon, Lyon, France
Centre Paradis-Monticelli
Marseille, Marseille, France
Hopitaux Universitaires
Strasbourg, Strasbourg, France
Inselspital
Bern, Canton of Bern, Switzerland
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.
Time frame: 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.
Time frame: 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.
Time frame: 12 weeks