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

NCT ID: NCT01086761

Last Updated: 2014-05-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2010-11-30

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.

Conditions

Wet Age-Related Macular Degeneration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MP0112 (0.04 mg)

Single 0.04 mg intravitreal injection of MP0112 in the study eye.

Group Type: EXPERIMENTAL

MP0112

Intervention Type: BIOLOGICAL

Single intravitreal injection of MP0112 in the study eye.

MP0112 (0.15 mg)

Single 0.15 mg intravitreal injection of MP0112 in the study eye.

Group Type: EXPERIMENTAL

MP0112

Intervention Type: BIOLOGICAL

Single intravitreal injection of MP0112 in the study eye.

MP0112 (0.4 mg)

Single 0.4 mg intravitreal injection of MP0112 in the study eye.

Group Type: EXPERIMENTAL

MP0112

Intervention Type: BIOLOGICAL

Single intravitreal injection of MP0112 in the study eye.

MP0112 (1.0 mg)

Single 1.0 mg intravitreal injection of MP0112 in the study eye.

Group Type: EXPERIMENTAL

MP0112

Intervention Type: BIOLOGICAL

Single intravitreal injection of MP0112 in the study eye.

MP0112 (2.0 mg)

Single 2.0 mg intravitreal injection of MP0112 in the study eye.

Group Type: EXPERIMENTAL

MP0112

Intervention Type: BIOLOGICAL

Single intravitreal injection of MP0112 in the study eye.

MP0112 (3.6 mg)

Single 3.6 mg intravitreal injection of MP0112 in the study eye.

Group Type: EXPERIMENTAL

MP0112

Intervention Type: BIOLOGICAL

Single intravitreal injection of MP0112 in the study eye.

Interventions

MP0112

Single intravitreal injection of MP0112 in the study eye.

Intervention Type: BIOLOGICAL

Eligibility 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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Molecular Partners AG

INDUSTRY

Sponsor Role: collaborator

Allergan

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Centre Rabelais

Lyon, Lyon, France

Centre Paradis-Monticelli

Marseille, Marseille, France

Hopitaux Universitaires

Strasbourg, Strasbourg, France

Inselspital

Bern, Canton of Bern, Switzerland

Countries

Czechia; France; Switzerland

References

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.

Reference Type: DERIVED

PMID: 24907435 (View on PubMed)

Other Identifiers

MP0112-CP01

Identifier Type: -

Identifier Source: org_study_id