Study of MP0112 Intravitreal Injection in Patients With Wet Age Related Macular Degeneration

This study has been terminated.
(The study was terminated due to a company decision following completion of Part A.)
Sponsor:
Collaborator:
Molecular Partners AG
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01086761
First received: March 9, 2010
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Wet Age-Related Macular Degeneration
Biological: MP0112
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II, Open-label, Non-controlled, Escalating Dose, Multicentre Clinical Trial Evaluating the Safety, Preliminary Efficacy, and Pharmacokinetics of MP0112 Injected Intravitreally in Patients With Wet Age Related Macular Degeneration (AMD)

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Maximal Tolerated Dose (MTD) Following a Single Injection [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Percentage of Participants With Stable or Improved Best Corrected Visual Acuity (BCVA) [ Time Frame: Baseline, Week 4 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Central Area Retinal Thickness [ Time Frame: Baseline, Week 4 ] [ Designated as safety issue: No ]
    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).

  • Area of Leakage as Measured by Fluorescein Angiography [ Time Frame: Baseline, Week 4 ] [ Designated as safety issue: No ]
    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.

  • Area of Lesion as Measured by Fluorescein Angiography [ Time Frame: Baseline, Week 4 ] [ Designated as safety issue: No ]
    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.

  • Maximum Serum Concentration (Cmax) of MP0112 at Day 3 [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Positive Binding Anti-MP0112 Antibodies [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 32
Study Start Date: March 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MP0112 (0.04 mg)
Single 0.04 mg intravitreal injection of MP0112 in the study eye.
Biological: MP0112
Single intravitreal injection of MP0112 in the study eye.
Experimental: MP0112 (0.15 mg)
Single 0.15 mg intravitreal injection of MP0112 in the study eye.
Biological: MP0112
Single intravitreal injection of MP0112 in the study eye.
Experimental: MP0112 (0.4 mg)
Single 0.4 mg intravitreal injection of MP0112 in the study eye.
Biological: MP0112
Single intravitreal injection of MP0112 in the study eye.
Experimental: MP0112 (1.0 mg)
Single 1.0 mg intravitreal injection of MP0112 in the study eye.
Biological: MP0112
Single intravitreal injection of MP0112 in the study eye.
Experimental: MP0112 (2.0 mg)
Single 2.0 mg intravitreal injection of MP0112 in the study eye.
Biological: MP0112
Single intravitreal injection of MP0112 in the study eye.
Experimental: MP0112 (3.6 mg)
Single 3.6 mg intravitreal injection of MP0112 in the study eye.
Biological: MP0112
Single intravitreal injection of MP0112 in the study eye.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical signs and angiographic evidence of active primary progressive subfoveal choroidal neovascularisation (CNV), including juxtafoveal lesions that affect the fovea on FA in the study eye that is at least 50% of the total lesion area
  • ETDRS best-corrected visual acuity of: 20/40 to 20/320 in the study eye at 4 meters
  • Male or female age > 50 years
  • Written informed consent prior to any study procedures
  • Willing, committed, and able to return for ALL clinic visits and complete all study-related procedures.

Exclusion Criteria:

  • Prior treatment with anti-VEGF therapy in the study eye, including bevacizumab, ranibizumab, or pegaptanib, as well as photodynamic therapy with verteporfin
  • Any prior or concomitant therapy with another investigational agent to treat neovascular AMD in the study eye, except dietary supplements or vitamins
  • Subfoveal thermal laser therapy, external-beam radiation therapy, or transpupillary thermotherapy in the study eye
  • Extrafoveal laser coagulation treatment within 12 weeks prior to Baseline in the study eye
  • Total lesion size > 20mm2 (including blood, scars and neovascularization) as assessed by FA in the study eye
  • Subretinal hemorrhage that is either 50% or more of the total lesion area, or if the blood is under the fovea and is 2.54mm2 or more in size in the study eye
  • Scar or fibrosis, making up > 50% of total lesion in the study eye
  • Scar, fibrosis, or atrophy involving the center of the fovea
  • Presence of retinal pigment epithelial tears or rips
  • History of any vitreous hemorrhage within 4 weeks prior to Visit 1 or current hemorrhage in the study eye
  • Presence of other causes of CNV, including pathologic myopia (spherical equivalent of -8 diopters or more negative, or axial length of 25 mm or more), ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, or multifocal choroiditis in the study eye
  • History or clinical evidence of diabetic retinopathy, diabetic macular oedema or any other vascular disease affecting the retina, other than AMD, in either eye
  • Prior vitrectomy in the study eye
  • History of retinal detachment or treatment or surgery for retinal detachment in the study eye
  • Ocular surgery (including cataract removal) in the study eye within 3 months of enrolment
  • Active intraocular inflammation (grade trace or above) in the study eye
  • History of allergy to any components of the study drug or diagnostic devices, such as fluorescein
  • Advanced glaucoma or intraocular pressure above 22 mmHg in the study eye despite treatment
  • Inability to obtain fundus photographs or fluorescein angiogram of sufficient quality to be analyzed and graded by the central reading center
  • History of idiopathic or autoimmune-associated uveitis in either eye
  • Infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
  • Aphakia or absence of the posterior capsule in the study eye
  • Presence of a non-healing wound, ulcer, fracture or any other medical condition associated with bleeding
  • Use of antimitotic or antimetabolite therapy within 30 days or 5 elimination half-lives of enrolment
  • Premenopausal women
  • Any disorder or condition that contraindicates the use of an investigational drug
  • Participation in another investigational drug study within 3 months of enrolment
  • Uncontrolled hypertension
  • Previous stroke within 12 months of study entry
  • Systemic treatment with any anti-VEGF drug
  • Current treatment for active systemic infection
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01086761

Locations
Czech Republic
Fakultni Nemocnice Brno
Brno, Czech, Czech Republic, 62500
Fakultni Nemocnice Olomouc
Olomouc, Czech, Czech Republic, 77520
Ustrendi Vojenska Nemocnice
Praha, Czech, Czech Republic, 16902
France
Hopital Intercommunual de Creteil
Creteil, France, 94010
Centre Rabelais
Lyon, France, 69003
Centre Paradis-Monticelli
Marseille, France, 13008
Hopitaux Universitaires
Strasbourg, France, 67091
Switzerland
Inselspital
Bern, Switzerland, CH-3010
Sponsors and Collaborators
Allergan
Molecular Partners AG
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01086761     History of Changes
Other Study ID Numbers: MP0112-CP01
Study First Received: March 9, 2010
Results First Received: April 14, 2014
Last Updated: April 14, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Czech Republic: State Institute for Drug Control
Switzerland: Swissmedic

Additional relevant MeSH terms:
Macular Degeneration
Eye Diseases
Retinal Degeneration
Retinal Diseases

ClinicalTrials.gov processed this record on October 22, 2014