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

This study has been terminated.
(The study was terminated due to a company decision following completion of Part A.)
Sponsor:
Collaborator:
Molecular Partners AG
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01086761
First received: March 9, 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: Wet Age-Related Macular Degeneration
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     9     7     6     6     4     0  
COMPLETED     9     7     6     6     4     0  
NOT COMPLETED     0     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.
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.
Total Total of all reporting groups

Baseline Measures
    MP0112 (0.04 mg)     MP0112 (0.15 mg)     MP0112 (0.4 mg)     MP0112 (1.0 mg)     MP0112 (2.0 mg)     Total  
Number of Participants  
[units: participants]
  9     7     6     6     4     32  
Age  
[units: Years]
Mean ± Standard Deviation
  78.2  ± 6.3     78.6  ± 3.2     77.5  ± 6.0     79.0  ± 3.0     77.8  ± 9.4     78.3  ± 5.3  
Gender  
[units: Participants]
           
Female     8     5     3     3     2     21  
Male     1     2     3     3     2     11  



  Outcome Measures
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1.  Primary:   Maximal Tolerated Dose (MTD) Following a Single Injection   [ Time Frame: 16 weeks ]

2.  Secondary:   Percentage of Participants With Stable or Improved Best Corrected Visual Acuity (BCVA)   [ Time Frame: Baseline, Week 4 ]

3.  Secondary:   Change From Baseline in Central Area Retinal Thickness   [ Time Frame: Baseline, Week 4 ]

4.  Secondary:   Area of Leakage as Measured by Fluorescein Angiography   [ Time Frame: Baseline, Week 4 ]

5.  Secondary:   Area of Lesion as Measured by Fluorescein Angiography   [ Time Frame: Baseline, Week 4 ]

6.  Secondary:   Maximum Serum Concentration (Cmax) of MP0112 at Day 3   [ Time Frame: Day 3 ]

7.  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: NCT01086761     History of Changes
Other Study ID Numbers: MP0112-CP01
Study First Received: March 9, 2010
Results First Received: April 14, 2014
Last Updated: April 14, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Czech Republic: State Institute for Drug Control
Switzerland: Swissmedic