Diabetic Macular EdemaPhase 1NCT01042678
Study of MP0112 Intravitreal Injection in Patients With Diabetic Macular Edema
A Phase 1 study testing MP0112 in people with Diabetic Macular Edema, run by Allergan at 4 sites in United States.
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 diabetic retinal edema. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Edema
- 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
- 18 participants
- Where
- 4 sitesUnited States
- Study dates
- Feb 2010to Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female age 18 years or older
- Macular edema due to diabetic retinopathy
- Best-corrected visual acuity in the study eye of 20/40 to 20/400
- Central subfield thickness ≥ 250 microns by OCT
- Females of childbearing potential must have a negative serum pregnancy test at Screening
- Male subjects must or be: 1) surgically sterilized for at least 6 months, or 2) use an appropriate method of barrier contraception (e.g., condoms with spermicide) and advise any sexual partner of child-bearing potential that she must also use a reliable method of contraception (e.g., hormonal contraceptive, intrauterine device, diaphragm with spermicide) during the study and for 30 days from study drug administration.
- Ability to understand the nature of the study and give written informed consent
- Willing, committed, and able to return for ALL clinic visits and complete all study-related procedures
Who cannot join
- Any indication of irreversible vision loss such as significant atrophy, scarring, fibrosis, or hyperpigmentation in the fovea
- Presence of significant ocular abnormalities in the study eye that prevent retinal assessment, including media opacities, cataract, or inadequate papillary dilation
- Presence of vision loss from another ocular disease other than DME
- History of any intraocular surgery within 3 months of Baseline
- History of intraocular injection of anti-VEGF agent or steroids within 3 months of Baseline
- History of laser photocoagulation for macular edema within 4 months prior to Baseline
Show all 15Show fewer
- Uncontrolled hypertension > 140 systolic or > 95 diastolic
- HbA1C ≥ 12%
- Creatinine: > 1.5 x upper limit of normal (ULN)
- Alanine transaminase (ALT), aspartate transaminase (AST), and gamma-glutamyl transferase (GGT): > ULN
- White blood cells (WBC), hematocrit, and platelets: < lower limit of normal (LLN)
- Heart rate < 60 beats per minute (bpm) or history of clinically significant bradycardia
- History of human immunodeficiency virus (HIV), chronic hepatitis B, or chronic hepatitis C infections
- Subjects with infections requiring hospitalization and/or antibiotic treatment 14 days prior to Baseline
- Subjects with any medical condition that in the judgment of the investigator could poise unacceptable risk to the subject or compromise interpretation of the data to be collected
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Retina Research Center
Austin, Texas, 78705
Wilmer Eye Institute
Baltimore, Maryland, 21287
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114
Retina Consultants of Houston
Houston, Texas, 77030
About this study
Official title: A Phase I/II, Open-label, Single Ascending Dose Study Evaluating the Safety, Preliminary Efficacy, and Pharmacokinetics of Intravitreal MP0112 in Patients With Diabetic Macular Edema (DME)
The purpose of this study is to assess the safety and tolerability of MP0112 (a novel, potentially long acting VEGF inhibitor) in patients with diabetic retinal edema.
- Conditions
- Diabetic Macular Edema
- 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 group | Role | What they receive |
|---|---|---|
| MP0112 (0.04 mg) | Experimental | Single 0.04 mg intravitreal injection of MP0112 in the study eye. Receives: Biological: MP0112 |
| MP0112 (0.15 mg) | Experimental | Single 0.15 mg intravitreal injection of MP0112 in the study eye. Receives: Biological: MP0112 |
| MP0112 (0.4 mg) | Experimental | Single 0.4 mg intravitreal injection of MP0112 in the study eye. Receives: Biological: MP0112 |
| MP0112 (1.0 mg) | Experimental | Single 1.0 mg intravitreal injection of MP0112 in the study eye. Receives: Biological: MP0112 |
| MP0112 (2.0 mg) | Experimental | Single 2.0 mg intravitreal injection of MP0112 in the study eye. Receives: Biological: MP0112 |
| MP0112 (3.6 mg) | Experimental | Single 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.
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Safety and tolerability was assessed by vital signs, clinical laboratory evaluations, ophthalmological examinations, intraocular pressure, the presence of anti-drug antibodies and the collection of adverse events. An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events.
Measured: 16 weeks
Secondary outcomes (5)
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 16. 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.
Measured: Baseline, Week 16
Change From Baseline in Foveal Thickness as Measured by Optical Coherence Tomography (OCT)
Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the fovea (part of the retina), was performed in the study eye after pupil dilation at Baseline and Week 16. A negative change from Baseline indicated improvement (less foveal thickness).
Measured: Baseline, Week 16
Serum Levels of MP0112
Blood samples were collected Pre-treatment (Baseline), Day 1 and 3, Weeks 1, 4, 12, 16. Serum samples (liquid portion of the blood after cells and clotting factors were removed) were sent to a laboratory for analysis. Levels of MP0112 were determined using an enzyme-linked immunosorbent assay.
Measured: 16 Weeks
Aqueous Humor Levels of MP0112
Aqueous humor (the thin, watery fluid in the eye) samples were collected from anterior chamber taps and were sent to a laboratory for analysis. Levels of MP0112 were determined using an enzyme-linked immunosorbent assay.
Measured: 1 Week
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.
- First posted5 Jan 2010 (estimated)
- Study startFeb 2010
- Primary completionDec 2010
- Study completionDec 2010
Why it stopped: The study was terminated due to a company decision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetic Macular EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Molecular Partners AG
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01042678
- Sponsor's protocol ID
- MP0112-CP02
- Status last verified
- Apr 2014
- First submitted
- 1 Jan 2010
- Last updated
- 13 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Open-label, Single Ascending Dose Study Evaluating the Safety, Preliminary Efficacy, and Pharmacokinetics of Intravitreal MP0112 in Patients With Diabetic Macular Edema (DME)
- ClinicalTrials.gov ID
- NCT01042678
- Acronym / sponsor ID
- MP0112-CP02
- Conditions
- Diabetic Macular Edema
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated due to a company decision.
- Enrolment
- 18 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Collaborators
- Molecular Partners AG
- Study start
- Feb 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 5 Jan 2010 (estimated)
- Results
- Posted 13 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the safety and tolerability of MP0112 (a novel, potentially long acting VEGF inhibitor) in patients with diabetic retinal edema.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| MP0112 (0.04 mg) | Experimental | Biological: MP0112Single 0.04 mg intravitreal injection of MP0112 in the study eye. |
| MP0112 (0.15 mg) | Experimental | Biological: MP0112Single 0.15 mg intravitreal injection of MP0112 in the study eye. |
| MP0112 (0.4 mg) | Experimental | Biological: MP0112Single 0.4 mg intravitreal injection of MP0112 in the study eye. |
| MP0112 (1.0 mg) | Experimental | Biological: MP0112Single 1.0 mg intravitreal injection of MP0112 in the study eye. |
| MP0112 (2.0 mg) | Experimental | Biological: MP0112Single 2.0 mg intravitreal injection of MP0112 in the study eye. |
| MP0112 (3.6 mg) | Experimental | Biological: MP0112Single 3.6 mg intravitreal injection of MP0112 in the study eye. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female age 18 years or older
- Macular edema due to diabetic retinopathy
- Best-corrected visual acuity in the study eye of 20/40 to 20/400
- Central subfield thickness ≥ 250 microns by OCT
- Females of childbearing potential must have a negative serum pregnancy test at Screening
Key exclusion criteria (15 listed)
- Any indication of irreversible vision loss such as significant atrophy, scarring, fibrosis, or hyperpigmentation in the fovea
- Presence of significant ocular abnormalities in the study eye that prevent retinal assessment, including media opacities, cataract, or inadequate papillary dilation
- Presence of vision loss from another ocular disease other than DME
- History of any intraocular surgery within 3 months of Baseline
- History of intraocular injection of anti-VEGF agent or steroids within 3 months of Baseline
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MP0112Single intravitreal injection of MP0112 in the study eye | Biological | MP0112 (0.04 mg), MP0112 (0.15 mg), MP0112 (0.4 mg), MP0112 (1.0 mg), MP0112 (2.0 mg), MP0112 (3.6 mg) |
Primary outcome
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time frame: 16 weeks
Safety and tolerability was assessed by vital signs, clinical laboratory evaluations, ophthalmological examinations, intraocular pressure, the presence of anti-drug antibodies and the collection of adverse events. An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events.
5 secondary outcomes
Best-Corrected Visual Acuity (BCVA)
Time frame: Baseline, Week 16
Change From Baseline in Foveal Thickness as Measured by Optical Coherence Tomography (OCT)
Time frame: Baseline, Week 16
Serum Levels of MP0112
Time frame: 16 Weeks
Aqueous Humor Levels of MP0112
Time frame: 1 Week
Number of Participants With Positive Binding Anti-MP0112 Antibodies
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MP0112 in people with Diabetic Macular Edema, run by Allergan at 4 sites in United States.
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 8 inclusion and 15 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 13 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 4 sites in United States. 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 13 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?
Number of Participants With Adverse Events as a Measure of Safety and Tolerability (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 May 2014.