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

NCT01086761 | Terminated Phase 1 Results DMC

• 1 other identifier: MP0112-CP01
• Study Type: interventional
• Target: 32
• Locations: 3 countries
• Sites: 8

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Percentage of Participants With Stable or Improved Best Corrected Visual Acuity (BCVA)

  Baseline, Week 4

• Change From Baseline in Central Area Retinal Thickness

  Baseline, Week 4

• Area of Leakage as Measured by Fluorescein Angiography

  Baseline, Week 4

• Area of Lesion as Measured by Fluorescein Angiography

  Baseline, Week 4

• Maximum Serum Concentration (Cmax) of MP0112 at Day 3

  Day 3

Study Arms (6)

MP0112 (0.04 mg)

EXPERIMENTAL

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

Biological: MP0112

MP0112 (0.15 mg)

EXPERIMENTAL

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

Biological: MP0112

MP0112 (0.4 mg)

EXPERIMENTAL

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

Biological: MP0112

MP0112 (1.0 mg)

EXPERIMENTAL

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

Biological: MP0112

MP0112 (2.0 mg)

EXPERIMENTAL

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

Biological: MP0112

MP0112 (3.6 mg)

EXPERIMENTAL

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

Biological: MP0112

Interventions

MP0112 BIOLOGICAL

Single intravitreal injection of MP0112 in the study eye.

MP0112 (0.04 mg); MP0112 (0.15 mg); MP0112 (0.4 mg); MP0112 (1.0 mg); MP0112 (2.0 mg); MP0112 (3.6 mg)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Allergan: lead
• Molecular Partners AG: collaborator

Study Sites (8)

Fakultni Nemocnice Brno

Brno, Czech, 62500, Czechia

Location

Fakultni Nemocnice Olomouc

Olomouc, Czech, 77520, Czechia

Location

Ustrendi Vojenska Nemocnice

Prague, Czech, 16902, Czechia

Location

Hopital Intercommunual de Creteil

Créteil, Creteil, 94010, France

Location

Centre Rabelais

Lyon, Lyon, 69003, France

Location

Centre Paradis-Monticelli

Marseille, Marseille, 13008, France

Location

Hopitaux Universitaires

Strasbourg, Strasbourg, 67091, France

Location

Inselspital

Bern, Canton of Bern, CH-3010, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 24907435 DERIVED

MeSH Terms

Interventions

MP0112

Results Point of Contact

• Title: Therapeutic Area Head,
• Organization: Allergan, Inc

clinicaltrials@allergan.com

714-246-4500

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2010
• First Posted: March 15, 2010
• Study Start: March 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: May 12, 2014
• Results First Posted: May 12, 2014

Record last verified: 2014-04

Locations

CH (1); CZ (3); FR (4)