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

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ClinicalTrials.gov Identifier: NCT01089517
Recruitment Status : Completed
First Posted : March 18, 2010
Results First Posted : January 3, 2014
Last Update Posted : May 12, 2017
Sponsor:
Information provided by (Responsible Party):
Ophthotech Corporation

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Age-Related Macular Degeneration
Interventions Drug: E10030 plus Lucentis
Drug: Lucentis
Enrollment 449
Recruitment Details This study enrolled 449 patients at approximately 69 centers in North America, South America, Europe and Israel.
Pre-assignment Details  
Arm/Group Title Lucentis E10030 0.3 mg/Lucentis 0.5 mg E10030 1.5 mg/Lucentis 0.5 mg
Hide Arm/Group Description Sham/Lucentis 0.5 mg E10030 0.3 mg/Lucentis 0.5 mg E10030 1.5 mg/Lucentis 0.5 mg
Period Title: Overall Study
Started 148 149 152
Completed 144 144 147
Not Completed 4 5 5
Arm/Group Title Lucentis E10030 Low Dose Plus Lucentis E10030 High Dose Plus Lucentis Total
Hide Arm/Group Description Sham/Lucentis 0.5 mg E10030 0.3 mg/Lucentis 0.5 mg E10030 1.5 mg/Lucentis 0.5 mg Total of all reporting groups
Overall Number of Baseline Participants 148 149 152 449
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 148 participants 149 participants 152 participants 449 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, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 148 participants 149 participants 152 participants 449 participants
78.0  (7.98) 77.6  (8.19) 77.8  (8.36) 77.8  (8.16)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 148 participants 149 participants 152 participants 449 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  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 148 participants 149 participants 152 participants 449 participants
United States 47 51 53 151
Europe 87 85 82 254
Israel 10 10 14 34
South America 4 3 3 10
1.Primary Outcome
Title Mean Change in Visual Acuity From Baseline at the Week 24 Visit
Hide Description The primary efficacy endpoint is the mean change in visual acuity from baseline at the Week 24 visit
Time Frame 24 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population (last observation carried forward)
Arm/Group Title Lucentis E10030 0.3 mg/Lucentis 0.5 mg E10030 1.5 mg/Lucentis 0.5 mg
Hide Arm/Group Description:
Sham/Lucentis 0.5 mg
E10030 0.3 mg/Lucentis 0.5 mg
E10030 1.5 mg/Lucentis 0.5 mg
Overall Number of Participants Analyzed 147 147 151
Mean (Standard Error)
Unit of Measure: ETDRS Letters
6.5  (1.09) 8.8  (1.09) 10.6  (1.07)
2.Secondary Outcome
Title The Proportion of Subjects Gaining 15 or More ETDRS Letters From Baseline at the Week 24 Visit
Hide Description The proportion of subjects gaining 15 or more ETDRS letters from baseline at the Week 24 visit
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population (last observation carried forward)
Arm/Group Title Lucentis E10030 0.3 mg/Lucentis 0.5 mg E10030 1.5 mg/Lucentis 0.5 mg
Hide Arm/Group Description:
Sham/Lucentis 0.5 mg
E10030 0.3 mg/Lucentis 0.5 mg
E10030 1.5 mg/Lucentis 0.5 mg
Overall Number of Participants Analyzed 147 147 151
Measure Type: Number
Unit of Measure: % subjects (i.e gaining >/=15 letters)
34.0 33.3 39.1
3.Secondary Outcome
Title Proportion of Patients With at Least 1 Adverse Event
Hide Description [Not Specified]
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Population
Arm/Group Title Lucentis E10030 0.3 mg/Lucentis 0.5 mg E10030 1.5 mg/Lucentis 0.5 mg
Hide Arm/Group Description:
Sham/Lucentis 0.5 mg
E10030 0.3 mg/Lucentis 0.5 mg
E10030 1.5 mg/Lucentis 0.5 mg
Overall Number of Participants Analyzed 148 149 152
Measure Type: Number
Unit of Measure: % of patients with adverse events
65.5 67.1 65.1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lucentis E10030 Low Dose Plus Lucentis E10030 High Dose Plus Lucentis
Hide Arm/Group Description Sham/Lucentis 0.5 mg E10030 0.3 mg/Lucentis 0.5 mg E10030 1.5 mg/Lucentis 0.5 mg
All-Cause Mortality
Lucentis E10030 Low Dose Plus Lucentis E10030 High Dose Plus Lucentis
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lucentis E10030 Low Dose Plus Lucentis E10030 High Dose Plus Lucentis
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   12/148 (8.11%)   14/149 (9.40%)   10/152 (6.58%) 
Cardiac disorders       
Aortic Valve Stenosis  1  0/148 (0.00%)  1/149 (0.67%)  0/152 (0.00%) 
Atrial Fibrillation  1  1/148 (0.68%)  1/149 (0.67%)  0/152 (0.00%) 
Atrial Flutter   0/148 (0.00%)  1/149 (0.67%)  0/152 (0.00%) 
Cardiac Failure   0/148 (0.00%)  0/149 (0.00%)  1/152 (0.66%) 
Cardiac Failure Congestive   1/148 (0.68%)  0/149 (0.00%)  1/152 (0.66%) 
Arrhythmia   1/148 (0.68%)  0/149 (0.00%)  0/152 (0.00%) 
Cardiac disorder   1/148 (0.68%)  0/149 (0.00%)  0/152 (0.00%) 
Eye disorders       
Corneal Erosion   0/148 (0.00%)  0/149 (0.00%)  1/152 (0.66%) 
Uveitis   0/148 (0.00%)  1/149 (0.67%)  0/152 (0.00%) 
Visual Acuity Reduced   1/148 (0.68%)  0/149 (0.00%)  0/152 (0.00%) 
Gastrointestinal disorders       
Abdominal Pain   0/148 (0.00%)  0/149 (0.00%)  1/152 (0.66%) 
Constipation   0/148 (0.00%)  0/149 (0.00%)  1/152 (0.66%) 
Duodenal Ulcer   0/148 (0.00%)  1/149 (0.67%)  0/152 (0.00%) 
Ileus   0/148 (0.00%)  1/149 (0.67%)  0/152 (0.00%) 
Inguinal Hernia, Obstructive   0/148 (0.00%)  0/149 (0.00%)  1/152 (0.66%) 
Rectal Hemmorrhage   0/148 (0.00%)  0/149 (0.00%)  1/152 (0.66%) 
Colitis ulcerative   1/148 (0.68%)  0/149 (0.00%)  0/152 (0.00%) 
Hepatobiliary disorders       
Cholelithiasis   1/148 (0.68%)  0/149 (0.00%)  0/152 (0.00%) 
Infections and infestations       
Osteomyelitis   0/148 (0.00%)  1/149 (0.67%)  0/152 (0.00%) 
Sepsis   0/148 (0.00%)  1/149 (0.67%)  0/152 (0.00%) 
Urinary Tract infection   0/148 (0.00%)  1/149 (0.67%)  0/152 (0.00%) 
Bronchitis   1/148 (0.68%)  0/149 (0.00%)  0/152 (0.00%) 
Injury, poisoning and procedural complications       
Subdural haematoma   1/148 (0.68%)  0/149 (0.00%)  0/152 (0.00%) 
Musculoskeletal and connective tissue disorders       
Back pain   0/148 (0.00%)  0/149 (0.00%)  2/152 (1.32%) 
Spondylitis   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   0/148 (0.00%)  1/149 (0.67%)  0/152 (0.00%) 
Metastatic Neoplasm   0/148 (0.00%)  1/149 (0.67%)  0/152 (0.00%) 
Neoplasm skin   0/148 (0.00%)  1/149 (0.67%)  0/152 (0.00%) 
Rectal Cancer   0/148 (0.00%)  0/149 (0.00%)  1/152 (0.66%) 
Benign salivary gland neoplasm   1/148 (0.68%)  0/149 (0.00%)  0/152 (0.00%) 
Brain Cancer Metastatic   1/148 (0.68%)  0/149 (0.00%)  0/152 (0.00%) 
Breast Cancer   1/148 (0.68%)  0/149 (0.00%)  0/152 (0.00%) 
Nervous system disorders       
Cerebral Infarction   0/148 (0.00%)  1/149 (0.67%)  0/152 (0.00%) 
Cerebrovascular Accident   2/148 (1.35%)  0/149 (0.00%)  0/152 (0.00%) 
Loss of Consciousness   1/148 (0.68%)  0/149 (0.00%)  0/152 (0.00%) 
Vascular Encephalopathy   1/148 (0.68%)  0/149 (0.00%)  0/152 (0.00%) 
Psychiatric disorders       
Mental status change   1/148 (0.68%)  0/149 (0.00%)  0/152 (0.00%) 
Renal and urinary disorders       
Renal colic   0/148 (0.00%)  0/149 (0.00%)  1/152 (0.66%) 
Respiratory, thoracic and mediastinal disorders       
Chronic Obstructive Pulmonary Disease   0/148 (0.00%)  2/149 (1.34%)  2/152 (1.32%) 
Asthma   0/148 (0.00%)  1/149 (0.67%)  0/152 (0.00%) 
Haemoptysis   0/148 (0.00%)  0/149 (0.00%)  1/152 (0.66%) 
Vascular disorders       
Arterial Disorder   0/148 (0.00%)  0/149 (0.00%)  1/152 (0.66%) 
Haematoma   0/148 (0.00%)  1/149 (0.67%)  0/152 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lucentis E10030 Low Dose Plus Lucentis E10030 High Dose Plus Lucentis
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   63/148 (42.57%)   63/149 (42.28%)   69/152 (45.39%) 
Eye disorders       
Conjunctival hemorrhage  1  37/148 (25.00%)  34/149 (22.82%)  51/152 (33.55%) 
Punctate Keratitis  1  10/148 (6.76%)  19/149 (12.75%)  15/152 (9.87%) 
Eye Pain  1  8/148 (5.41%)  10/149 (6.71%)  13/152 (8.55%) 
Conjunctival hyperemia  1  13/148 (8.78%)  9/149 (6.04%)  13/152 (8.55%) 
Subretinal fibrosis  1  8/148 (5.41%)  6/149 (4.03%)  5/152 (3.29%) 
Investigations       
Intraocular pressure increased  1  4/148 (2.70%)  8/149 (5.37%)  9/152 (5.92%) 
Vascular disorders       
Hypertension  1  8/148 (5.41%)  7/149 (4.70%)  5/152 (3.29%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.1)
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.
No individual site or investigator may publish or present any results from the trial until a joint, multi center publication of the trial results is made by Sponsor in conjunction with various participating investigators and appropriate sites contributing data and comments. Subsequently, individual investigators may request to publish or present results from the trial; however, approval will be at the sole discretion of the Sponsor.
Results Point of Contact
Name/Title: Jeffrey Nau
Organization: Ophthotech
Phone: 646-573-7045
Responsible Party: Ophthotech Corporation
ClinicalTrials.gov Identifier: NCT01089517     History of Changes
Other Study ID Numbers: OPH1001
First Submitted: March 12, 2010
First Posted: March 18, 2010
Results First Submitted: November 13, 2013
Results First Posted: January 3, 2014
Last Update Posted: May 12, 2017