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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: April 6, 2017
Last verified: April 2017
History of Changes
Results First Received: November 13, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Care Provider, 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 0.3 mg/Lucentis 0.5 mg E10030 0.3 mg/Lucentis 0.5 mg
E10030 1.5 mg/Lucentis 0.5 mg E10030 1.5 mg/Lucentis 0.5 mg

Participant Flow:   Overall Study
    Lucentis   E10030 0.3 mg/Lucentis 0.5 mg   E10030 1.5 mg/Lucentis 0.5 mg
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 
Overall Participants Analyzed 
[Units: Participants]
 		 148   149   152   449 
Age 
[Units: Participants]
Count of Participants 		       
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      8   5.4%      10   6.7%      11   7.2%      29   6.5% 
>=65 years      140  94.6%      139  93.3%      141  92.8%      420  93.5% 
Age 
[Units: Years]
Mean (Standard Deviation) 		 78.0  (7.98)   77.6  (8.19)   77.8  (8.36)   77.8  (8.16) 
Sex: Female, Male 
[Units: Participants]
Count of Participants 		       
Female      93  62.8%      90  60.4%      92  60.5%      275  61.2% 
Male      55  37.2%      59  39.6%      60  39.5%      174  38.8% 
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 ]
  Show Outcome Measure 1

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

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


  Serious Adverse Events
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Time Frame No text entered.
Additional Description 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

Serious Adverse Events
    Lucentis   E10030 Low Dose Plus Lucentis   E10030 High Dose Plus Lucentis
Total, Serious Adverse Events       
# participants affected / at risk   12/148 (8.11%)   14/149 (9.40%)   10/152 (6.58%) 
Cardiac disorders       
Aortic Valve Stenosis † 1       
# participants affected / at risk   0/148 (0.00%)   1/149 (0.67%)   0/152 (0.00%) 
Atrial Fibrillation † 1       
# participants affected / at risk   1/148 (0.68%)   1/149 (0.67%)   0/152 (0.00%) 
Atrial Flutter †       
# participants affected / at risk   0/148 (0.00%)   1/149 (0.67%)   0/152 (0.00%) 
Cardiac Failure †       
# participants affected / at risk   0/148 (0.00%)   0/149 (0.00%)   1/152 (0.66%) 
Cardiac Failure Congestive †       
# participants affected / at risk   1/148 (0.68%)   0/149 (0.00%)   1/152 (0.66%) 
Arrhythmia †       
# participants affected / at risk   1/148 (0.68%)   0/149 (0.00%)   0/152 (0.00%) 
Cardiac disorder †       
# participants affected / at risk   1/148 (0.68%)   0/149 (0.00%)   0/152 (0.00%) 
Eye disorders       
Corneal Erosion †       
# participants affected / at risk   0/148 (0.00%)   0/149 (0.00%)   1/152 (0.66%) 
Uveitis †       
# participants affected / at risk   0/148 (0.00%)   1/149 (0.67%)   0/152 (0.00%) 
Visual Acuity Reduced †       
# participants affected / at risk   1/148 (0.68%)   0/149 (0.00%)   0/152 (0.00%) 
Gastrointestinal disorders       
Abdominal Pain †       
# participants affected / at risk   0/148 (0.00%)   0/149 (0.00%)   1/152 (0.66%) 
Constipation †       
# participants affected / at risk   0/148 (0.00%)   0/149 (0.00%)   1/152 (0.66%) 
Duodenal Ulcer †       
# participants affected / at risk   0/148 (0.00%)   1/149 (0.67%)   0/152 (0.00%) 
Ileus †       
# participants affected / at risk   0/148 (0.00%)   1/149 (0.67%)   0/152 (0.00%) 
Inguinal Hernia, Obstructive †       
# participants affected / at risk   0/148 (0.00%)   0/149 (0.00%)   1/152 (0.66%) 
Rectal Hemmorrhage †       
# participants affected / at risk   0/148 (0.00%)   0/149 (0.00%)   1/152 (0.66%) 
Colitis ulcerative †       
# participants affected / at risk   1/148 (0.68%)   0/149 (0.00%)   0/152 (0.00%) 
Hepatobiliary disorders       
Cholelithiasis †       
# participants affected / at risk   1/148 (0.68%)   0/149 (0.00%)   0/152 (0.00%) 
Infections and infestations       
Osteomyelitis †       
# participants affected / at risk   0/148 (0.00%)   1/149 (0.67%)   0/152 (0.00%) 
Sepsis †       
# participants affected / at risk   0/148 (0.00%)   1/149 (0.67%)   0/152 (0.00%) 
Urinary Tract infection †       
# participants affected / at risk   0/148 (0.00%)   1/149 (0.67%)   0/152 (0.00%) 
Bronchitis †       
# participants affected / at risk   1/148 (0.68%)   0/149 (0.00%)   0/152 (0.00%) 
Injury, poisoning and procedural complications       
Subdural haematoma †       
# participants affected / at risk   1/148 (0.68%)   0/149 (0.00%)   0/152 (0.00%) 
Musculoskeletal and connective tissue disorders       
Back pain †       
# participants affected / at risk   0/148 (0.00%)   0/149 (0.00%)   2/152 (1.32%) 
Spondylitis †       
# participants affected / at risk   1/148 (0.68%)   0/149 (0.00%)   0/152 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Lung squamous cell carcinoma, unspecified †       
# participants affected / at risk   0/148 (0.00%)   1/149 (0.67%)   0/152 (0.00%) 
Metastatic Neoplasm †       
# participants affected / at risk   0/148 (0.00%)   1/149 (0.67%)   0/152 (0.00%) 
Neoplasm skin †       
# participants affected / at risk   0/148 (0.00%)   1/149 (0.67%)   0/152 (0.00%) 
Rectal Cancer †       
# participants affected / at risk   0/148 (0.00%)   0/149 (0.00%)   1/152 (0.66%) 
Benign salivary gland neoplasm †       
# participants affected / at risk   1/148 (0.68%)   0/149 (0.00%)   0/152 (0.00%) 
Brain Cancer Metastatic †       
# participants affected / at risk   1/148 (0.68%)   0/149 (0.00%)   0/152 (0.00%) 
Breast Cancer †       
# participants affected / at risk   1/148 (0.68%)   0/149 (0.00%)   0/152 (0.00%) 
Nervous system disorders       
Cerebral Infarction †       
# participants affected / at risk   0/148 (0.00%)   1/149 (0.67%)   0/152 (0.00%) 
Cerebrovascular Accident †       
# participants affected / at risk   2/148 (1.35%)   0/149 (0.00%)   0/152 (0.00%) 
Loss of Consciousness †       
# participants affected / at risk   1/148 (0.68%)   0/149 (0.00%)   0/152 (0.00%) 
Vascular Encephalopathy †       
# participants affected / at risk   1/148 (0.68%)   0/149 (0.00%)   0/152 (0.00%) 
Psychiatric disorders       
Mental status change †       
# participants affected / at risk   1/148 (0.68%)   0/149 (0.00%)   0/152 (0.00%) 
Renal and urinary disorders       
Renal colic †       
# participants affected / at risk   0/148 (0.00%)   0/149 (0.00%)   1/152 (0.66%) 
Respiratory, thoracic and mediastinal disorders       
Chronic Obstructive Pulmonary Disease †       
# participants affected / at risk   0/148 (0.00%)   2/149 (1.34%)   2/152 (1.32%) 
Asthma †       
# participants affected / at risk   0/148 (0.00%)   1/149 (0.67%)   0/152 (0.00%) 
Haemoptysis †       
# participants affected / at risk   0/148 (0.00%)   0/149 (0.00%)   1/152 (0.66%) 
Vascular disorders       
Arterial Disorder †       
# participants affected / at risk   0/148 (0.00%)   0/149 (0.00%)   1/152 (0.66%) 
Haematoma †       
# participants affected / at risk   0/148 (0.00%)   1/149 (0.67%)   0/152 (0.00%) 
† Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 11.1




  Other Adverse Events
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  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
No text entered.


  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: Jeffrey Nau
Organization: Ophthotech
phone: 646-573-7045
e-mail: jeff.nau@ophthotech.com



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: April 6, 2017