Study of MP0112 Intravitreal Injection in Patients With Diabetic Macular Edema

This study has been terminated.
(The study was terminated due to a company decision.)
Sponsor:
Collaborator:
Molecular Partners AG
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01042678
First received: January 1, 2010
Last updated: April 14, 2014
Last verified: April 2014
Results First Received: April 14, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Diabetic Macular Edema
Intervention: Biological: MP0112

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
MP0112 (0.04 mg) Single 0.04 mg intravitreal injection of MP0112 in the study eye.
MP0112 (0.15 mg) Single 0.15 mg intravitreal injection of MP0112 in the study eye.
MP0112 (0.4 mg) Single 0.4 mg intravitreal injection of MP0112 in the study eye.
MP0112 (1.0 mg) Single 1.0 mg intravitreal injection of MP0112 in the study eye.
MP0112 (2.0 mg) Single 2.0 mg intravitreal injection of MP0112 in the study eye.
MP0112 (3.6 mg) Single 3.6 mg intravitreal injection of MP0112 in the study eye.

Participant Flow:   Overall Study
    MP0112 (0.04 mg)     MP0112 (0.15 mg)     MP0112 (0.4 mg)     MP0112 (1.0 mg)     MP0112 (2.0 mg)     MP0112 (3.6 mg)  
STARTED     6     6     6     0     0     0  
COMPLETED     5     6     6     0     0     0  
NOT COMPLETED     1     0     0     0     0     0  
Physician Decision                 1                 0                 0                 0                 0                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
MP0112 (0.04 mg) Single 0.04 mg intravitreal injection of MP0112 in the study eye.
MP0112 (0.15 mg) Single 0.15 mg intravitreal injection of MP0112 in the study eye.
MP0112 (0.4 mg) Single 0.4 mg intravitreal injection of MP0112 in the study eye.
Total Total of all reporting groups

Baseline Measures
    MP0112 (0.04 mg)     MP0112 (0.15 mg)     MP0112 (0.4 mg)     Total  
Number of Participants  
[units: participants]
  6     6     6     18  
Age  
[units: Years]
Mean ± Standard Deviation
  62.7  ± 8.4     67.5  ± 9.9     64.2  ± 10.3     64.8  ± 9.2  
Gender  
[units: Participants]
       
Female     2     3     2     7  
Male     4     3     4     11  



  Outcome Measures
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1.  Primary:   Number of Participants With Adverse Events as a Measure of Safety and Tolerability   [ Time Frame: 16 weeks ]

2.  Secondary:   Best-Corrected Visual Acuity (BCVA)   [ Time Frame: Baseline, Week 16 ]

3.  Secondary:   Change From Baseline in Foveal Thickness as Measured by Optical Coherence Tomography (OCT)   [ Time Frame: Baseline, Week 16 ]

4.  Secondary:   Serum Levels of MP0112   [ Time Frame: 16 Weeks ]

5.  Secondary:   Aqueous Humor Levels of MP0112   [ Time Frame: 1 Week ]

6.  Secondary:   Number of Participants With Positive Binding Anti-MP0112 Antibodies   [ Time Frame: 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Therapeutic Area Head,
Organization: Allergan, Inc
phone: 714-246-4500
e-mail: clinicaltrials@allergan.com


No publications provided


Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01042678     History of Changes
Other Study ID Numbers: MP0112-CP02
Study First Received: January 1, 2010
Results First Received: April 14, 2014
Last Updated: April 14, 2014
Health Authority: United States: Food and Drug Administration