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Wet Age-Related Macular DegenerationPhase 1NCT01086761

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

A Phase 1 study testing MP0112 in people with Wet Age-Related Macular Degeneration, run by Allergan at 8 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Wet Age-Related Macular Degeneration
What is being tested?
MP0112
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
8 sitesin 3 countries
Study dates
Mar 2010to Nov 2010
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 31Show fewer
  • 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

Trial locations and contacts

8 sites in 3 countries.

8 sites in 3 countries

France4 sites

  • Hopital Intercommunual de Creteil

    Créteil, Creteil, 94010

  • Centre Rabelais

    Lyon, Lyon, 69003

  • Centre Paradis-Monticelli

    Marseille, Marseille, 13008

  • Hopitaux Universitaires

    Strasbourg, Strasbourg, 67091

Other trials in France

Czechia3 sites

  • Fakultni Nemocnice Brno

    Brno, Czech, 62500

  • Fakultni Nemocnice Olomouc

    Olomouc, Czech, 77520

  • Ustrendi Vojenska Nemocnice

    Prague, Czech, 16902

Other trials in Czechia

Switzerland1 site

  • Inselspital

    Bern, Canton of Bern, CH-3010

Other trials in Switzerland

About this study

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)

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.

Being tested
MP0112

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MP0112Biological

    Single intravitreal injection of MP0112 in the study eye.

Study groups in NCT01086761
Study groupRoleWhat they receive
MP0112 (0.04 mg)ExperimentalSingle 0.04 mg intravitreal injection of MP0112 in the study eye.
Receives: Biological: MP0112
MP0112 (0.15 mg)ExperimentalSingle 0.15 mg intravitreal injection of MP0112 in the study eye.
Receives: Biological: MP0112
MP0112 (0.4 mg)ExperimentalSingle 0.4 mg intravitreal injection of MP0112 in the study eye.
Receives: Biological: MP0112
MP0112 (1.0 mg)ExperimentalSingle 1.0 mg intravitreal injection of MP0112 in the study eye.
Receives: Biological: MP0112
MP0112 (2.0 mg)ExperimentalSingle 2.0 mg intravitreal injection of MP0112 in the study eye.
Receives: Biological: MP0112
MP0112 (3.6 mg)ExperimentalSingle 3.6 mg intravitreal injection of MP0112 in the study eye.
Receives: Biological: MP0112

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 16 weeks

Secondary outcomes (6)

  1. 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.

    Measured: Baseline, Week 4

  2. 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).

    Measured: Baseline, Week 4

  3. 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.

    Measured: Baseline, Week 4

  4. 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.

    Measured: Baseline, Week 4

  5. 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.

    Measured: Day 3

  6. 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.

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2010 (estimated)
  2. Study startMar 2010
  3. Primary completionNov 2010
  4. Study completionNov 2010

Why it stopped: The study was terminated due to a company decision following completion of Part A.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01086761
Sponsor's protocol ID
MP0112-CP01
Status last verified
Apr 2014
First submitted
9 Mar 2010
Last updated
12 May 2014
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 24907435

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MP0112 in people with Wet Age-Related Macular Degeneration, run by Allergan at 8 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 12 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in France, Czechia, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximal Tolerated Dose (MTD) Following a Single Injection (time frame: 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01086761, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2014.

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