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: November 21, 2011

Last verified: November 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	March 9, 2010
Last Updated Date	November 21, 2011
Start Date ^ICMJE	March 2010
Primary Completion Date	November 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 12, 2010)	Safety and tolerability, Safety assessments will be done for 16 weeks after intraocular injection of MP0112. [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ] Determination of the maximal tolerated dose (MTD) following a single injection (Part A only) All ocular and systemic adverse events, including serious adverse events whether related or not to study treatment or study procedures Vital signs, as well as the haematological and blood chemistry laboratory values after treatment as compared with their values before treatment.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01086761 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 12, 2010)	The change from baseline in best-corrected visual acuity (BCVA) over 16 weeks after injection of MP0112. [ Time Frame: Baseline, 16 weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Study of MP0112 Intravitreal Injection in Patients With Wet Age Related Macular Degeneration
Official Title ^ICMJE	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)
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Wet Age-Related Macular Degeneration
Intervention ^ICMJE	Biological: MP0112 DARPin
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	32
Completion Date	November 2010
Primary Completion Date	November 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	50 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Czech Republic, France, Switzerland

Administrative Information
NCT Number ^ICMJE	NCT01086761
Other Study ID Numbers ^ICMJE	MP0112-CP01
Has Data Monitoring Committee	Yes
Responsible Party	Allergan
Study Sponsor ^ICMJE	Allergan
Collaborators ^ICMJE	Molecular Partners AG
Investigators ^ICMJE	Not Provided
Information Provided By	Allergan
Verification Date	November 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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