A Safety and Efficacy Study of E10030 (Anti-PDGF Pegylated Aptamer) Plus Lucentis for Neovascular Age-Related Macular Degeneration

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ophthotech Corporation
ClinicalTrials.gov Identifier:
NCT01089517
First received: March 12, 2010
Last updated: November 13, 2013
Last verified: November 2013
Results First Received: November 13, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Age-Related Macular Degeneration
Interventions: Drug: E10030 plus Lucentis
Drug: Lucentis

  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
This study enrolled 449 patients at approximately 69 centers in North America, South America, Europe and Israel.

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
Lucentis Sham/Lucentis 0.5 mg
E10030 Low Dose Plus Lucentis E10030 0.3 mg/Lucentis 0.5 mg
E10030 High Dose Plus Lucentis E10030 1.5 mg/Lucentis 0.5 mg

Participant Flow:   Overall Study
    Lucentis     E10030 Low Dose Plus Lucentis     E10030 High Dose Plus Lucentis  
STARTED     148     149     152  
COMPLETED     144     144     147  
NOT COMPLETED     4     5     5  



  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
Lucentis Sham/Lucentis 0.5 mg
E10030 Low Dose Plus Lucentis E10030 0.3 mg/Lucentis 0.5 mg
E10030 High Dose Plus Lucentis E10030 1.5 mg/Lucentis 0.5 mg
Total Total of all reporting groups

Baseline Measures
    Lucentis     E10030 Low Dose Plus Lucentis     E10030 High Dose Plus Lucentis     Total  
Number of Participants  
[units: participants]
  148     149     152     449  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     8     10     11     29  
>=65 years     140     139     141     420  
Age  
[units: years]
Mean ± Standard Deviation
  78.0  ± 7.98     77.6  ± 8.19     77.8  ± 8.36     77.8  ± 8.16  
Gender  
[units: participants]
       
Female     93     90     92     275  
Male     55     59     60     174  
Region of Enrollment  
[units: participants]
       
United States     47     51     53     151  
Europe     87     85     82     254  
Israel     10     10     14     34  
South America     4     3     3     10  



  Outcome Measures
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1.  Primary:   Mean Change in Visual Acuity From Baseline at the Week 24 Visit   [ Time Frame: 24 Weeks ]

2.  Secondary:   The Proportion of Subjects Gaining 15 or More ETDRS Letters From Baseline at the Week 24 Visit   [ Time Frame: 24 weeks ]

3.  Secondary:   Proportion of Patients With at Least 1 Adverse Event   [ Time Frame: 24 weeks ]


  Serious Adverse Events


  Other Adverse Events


  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.


Limitations and Caveats
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
No text entered.  


Results Point of Contact:  
Name/Title: Jeffrey Nau
Organization: Ophthotech
phone: 646-573-7045
e-mail: jeff.nau@ophthotech.com


No publications provided


Responsible Party: Ophthotech Corporation
ClinicalTrials.gov Identifier: NCT01089517     History of Changes
Other Study ID Numbers: OPH1001
Study First Received: March 12, 2010
Results First Received: November 13, 2013
Last Updated: November 13, 2013
Health Authority: United States: Food and Drug Administration