Trial Outcomes & Findings for A Safety and Efficacy Study of E10030 (Anti-PDGF Pegylated Aptamer) Plus Lucentis for Neovascular Age-Related Macular Degeneration (NCT NCT01089517)
NCT ID: NCT01089517
Last Updated: 2024-03-19
Results Overview
The primary efficacy endpoint is the mean change in visual acuity from baseline at the Week 24 visit
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
449 participants
Primary outcome timeframe
24 Weeks
Results posted on
2024-03-19
Participant Flow
This study enrolled 449 patients at approximately 69 centers in North America, South America, Europe and Israel.
Participant milestones
| Measure |
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
148
|
149
|
152
|
|
Overall Study
COMPLETED
|
144
|
144
|
147
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Safety and Efficacy Study of E10030 (Anti-PDGF Pegylated Aptamer) Plus Lucentis for Neovascular Age-Related Macular Degeneration
Baseline characteristics by cohort
| Measure |
Lucentis
n=148 Participants
Sham/Lucentis 0.5 mg
|
E10030 Low Dose Plus Lucentis
n=149 Participants
E10030 0.3 mg/Lucentis 0.5 mg
|
E10030 High Dose Plus Lucentis
n=152 Participants
E10030 1.5 mg/Lucentis 0.5 mg
|
Total
n=449 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
140 Participants
n=5 Participants
|
139 Participants
n=7 Participants
|
141 Participants
n=5 Participants
|
420 Participants
n=4 Participants
|
|
Age, Continuous
|
78.0 years
STANDARD_DEVIATION 7.98 • n=5 Participants
|
77.6 years
STANDARD_DEVIATION 8.19 • n=7 Participants
|
77.8 years
STANDARD_DEVIATION 8.36 • n=5 Participants
|
77.8 years
STANDARD_DEVIATION 8.16 • n=4 Participants
|
|
Sex: Female, Male
Female
|
93 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
275 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
174 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
47 participants
n=5 Participants
|
51 participants
n=7 Participants
|
53 participants
n=5 Participants
|
151 participants
n=4 Participants
|
|
Region of Enrollment
Europe
|
87 participants
n=5 Participants
|
85 participants
n=7 Participants
|
82 participants
n=5 Participants
|
254 participants
n=4 Participants
|
|
Region of Enrollment
Israel
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
14 participants
n=5 Participants
|
34 participants
n=4 Participants
|
|
Region of Enrollment
South America
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
10 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 24 WeeksPopulation: Intent to Treat Population (last observation carried forward)
The primary efficacy endpoint is the mean change in visual acuity from baseline at the Week 24 visit
Outcome measures
| Measure |
Lucentis
n=147 Participants
Sham/Lucentis 0.5 mg
|
E10030 0.3 mg/Lucentis 0.5 mg
n=147 Participants
E10030 0.3 mg/Lucentis 0.5 mg
|
E10030 1.5 mg/Lucentis 0.5 mg
n=151 Participants
E10030 1.5 mg/Lucentis 0.5 mg
|
|---|---|---|---|
|
Mean Change in Visual Acuity From Baseline at the Week 24 Visit
|
6.5 ETDRS Letters
Standard Error 1.09
|
8.8 ETDRS Letters
Standard Error 1.09
|
10.6 ETDRS Letters
Standard Error 1.07
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Intent to Treat Population (last observation carried forward)
The proportion of subjects gaining 15 or more ETDRS letters from baseline at the Week 24 visit
Outcome measures
| Measure |
Lucentis
n=147 Participants
Sham/Lucentis 0.5 mg
|
E10030 0.3 mg/Lucentis 0.5 mg
n=147 Participants
E10030 0.3 mg/Lucentis 0.5 mg
|
E10030 1.5 mg/Lucentis 0.5 mg
n=151 Participants
E10030 1.5 mg/Lucentis 0.5 mg
|
|---|---|---|---|
|
The Proportion of Subjects Gaining 15 or More ETDRS Letters From Baseline at the Week 24 Visit
|
34.0 % subjects (i.e gaining >/=15 letters)
|
33.3 % subjects (i.e gaining >/=15 letters)
|
39.1 % subjects (i.e gaining >/=15 letters)
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Safety Analysis Population
Outcome measures
| Measure |
Lucentis
n=148 Participants
Sham/Lucentis 0.5 mg
|
E10030 0.3 mg/Lucentis 0.5 mg
n=149 Participants
E10030 0.3 mg/Lucentis 0.5 mg
|
E10030 1.5 mg/Lucentis 0.5 mg
n=152 Participants
E10030 1.5 mg/Lucentis 0.5 mg
|
|---|---|---|---|
|
Proportion of Patients With at Least 1 Adverse Event
|
65.5 % of patients with adverse events
|
67.1 % of patients with adverse events
|
65.1 % of patients with adverse events
|
Adverse Events
Lucentis
Serious events: 12 serious events
Other events: 63 other events
Deaths: 0 deaths
E10030 Low Dose Plus Lucentis
Serious events: 14 serious events
Other events: 63 other events
Deaths: 0 deaths
E10030 High Dose Plus Lucentis
Serious events: 10 serious events
Other events: 69 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lucentis
n=148 participants at risk
Sham/Lucentis 0.5 mg
|
E10030 Low Dose Plus Lucentis
n=149 participants at risk
E10030 0.3 mg/Lucentis 0.5 mg
|
E10030 High Dose Plus Lucentis
n=152 participants at risk
E10030 1.5 mg/Lucentis 0.5 mg
|
|---|---|---|---|
|
Cardiac disorders
Aortic Valve Stenosis
|
0.00%
0/148
|
0.67%
1/149
|
0.00%
0/152
|
|
Cardiac disorders
Atrial Fibrillation
|
0.68%
1/148
|
0.67%
1/149
|
0.00%
0/152
|
|
Cardiac disorders
Atrial Flutter
|
0.00%
0/148
|
0.67%
1/149
|
0.00%
0/152
|
|
Cardiac disorders
Cardiac Failure
|
0.00%
0/148
|
0.00%
0/149
|
0.66%
1/152
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.68%
1/148
|
0.00%
0/149
|
0.66%
1/152
|
|
Cardiac disorders
Arrhythmia
|
0.68%
1/148
|
0.00%
0/149
|
0.00%
0/152
|
|
Cardiac disorders
Cardiac disorder
|
0.68%
1/148
|
0.00%
0/149
|
0.00%
0/152
|
|
Eye disorders
Corneal Erosion
|
0.00%
0/148
|
0.00%
0/149
|
0.66%
1/152
|
|
Eye disorders
Uveitis
|
0.00%
0/148
|
0.67%
1/149
|
0.00%
0/152
|
|
Eye disorders
Visual Acuity Reduced
|
0.68%
1/148
|
0.00%
0/149
|
0.00%
0/152
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/148
|
0.00%
0/149
|
0.66%
1/152
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/148
|
0.00%
0/149
|
0.66%
1/152
|
|
Gastrointestinal disorders
Duodenal Ulcer
|
0.00%
0/148
|
0.67%
1/149
|
0.00%
0/152
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/148
|
0.67%
1/149
|
0.00%
0/152
|
|
Gastrointestinal disorders
Inguinal Hernia, Obstructive
|
0.00%
0/148
|
0.00%
0/149
|
0.66%
1/152
|
|
Gastrointestinal disorders
Rectal Hemmorrhage
|
0.00%
0/148
|
0.00%
0/149
|
0.66%
1/152
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.68%
1/148
|
0.00%
0/149
|
0.00%
0/152
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.68%
1/148
|
0.00%
0/149
|
0.00%
0/152
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/148
|
0.67%
1/149
|
0.00%
0/152
|
|
Infections and infestations
Sepsis
|
0.00%
0/148
|
0.67%
1/149
|
0.00%
0/152
|
|
Infections and infestations
Urinary Tract infection
|
0.00%
0/148
|
0.67%
1/149
|
0.00%
0/152
|
|
Infections and infestations
Bronchitis
|
0.68%
1/148
|
0.00%
0/149
|
0.00%
0/152
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.68%
1/148
|
0.00%
0/149
|
0.00%
0/152
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/148
|
0.00%
0/149
|
1.3%
2/152
|
|
Musculoskeletal and connective tissue disorders
Spondylitis
|
0.68%
1/148
|
0.00%
0/149
|
0.00%
0/152
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung squamous cell carcinoma, unspecified
|
0.00%
0/148
|
0.67%
1/149
|
0.00%
0/152
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic Neoplasm
|
0.00%
0/148
|
0.67%
1/149
|
0.00%
0/152
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm skin
|
0.00%
0/148
|
0.67%
1/149
|
0.00%
0/152
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal Cancer
|
0.00%
0/148
|
0.00%
0/149
|
0.66%
1/152
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign salivary gland neoplasm
|
0.68%
1/148
|
0.00%
0/149
|
0.00%
0/152
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain Cancer Metastatic
|
0.68%
1/148
|
0.00%
0/149
|
0.00%
0/152
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.68%
1/148
|
0.00%
0/149
|
0.00%
0/152
|
|
Nervous system disorders
Cerebral Infarction
|
0.00%
0/148
|
0.67%
1/149
|
0.00%
0/152
|
|
Nervous system disorders
Cerebrovascular Accident
|
1.4%
2/148
|
0.00%
0/149
|
0.00%
0/152
|
|
Nervous system disorders
Loss of Consciousness
|
0.68%
1/148
|
0.00%
0/149
|
0.00%
0/152
|
|
Nervous system disorders
Vascular Encephalopathy
|
0.68%
1/148
|
0.00%
0/149
|
0.00%
0/152
|
|
Psychiatric disorders
Mental status change
|
0.68%
1/148
|
0.00%
0/149
|
0.00%
0/152
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/148
|
0.00%
0/149
|
0.66%
1/152
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.00%
0/148
|
1.3%
2/149
|
1.3%
2/152
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/148
|
0.67%
1/149
|
0.00%
0/152
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/148
|
0.00%
0/149
|
0.66%
1/152
|
|
Vascular disorders
Arterial Disorder
|
0.00%
0/148
|
0.00%
0/149
|
0.66%
1/152
|
|
Vascular disorders
Haematoma
|
0.00%
0/148
|
0.67%
1/149
|
0.00%
0/152
|
Other adverse events
| Measure |
Lucentis
n=148 participants at risk
Sham/Lucentis 0.5 mg
|
E10030 Low Dose Plus Lucentis
n=149 participants at risk
E10030 0.3 mg/Lucentis 0.5 mg
|
E10030 High Dose Plus Lucentis
n=152 participants at risk
E10030 1.5 mg/Lucentis 0.5 mg
|
|---|---|---|---|
|
Eye disorders
Conjunctival hemorrhage
|
25.0%
37/148
|
22.8%
34/149
|
33.6%
51/152
|
|
Eye disorders
Punctate Keratitis
|
6.8%
10/148
|
12.8%
19/149
|
9.9%
15/152
|
|
Eye disorders
Eye Pain
|
5.4%
8/148
|
6.7%
10/149
|
8.6%
13/152
|
|
Eye disorders
Conjunctival hyperemia
|
8.8%
13/148
|
6.0%
9/149
|
8.6%
13/152
|
|
Eye disorders
Subretinal fibrosis
|
5.4%
8/148
|
4.0%
6/149
|
3.3%
5/152
|
|
Investigations
Intraocular pressure increased
|
2.7%
4/148
|
5.4%
8/149
|
5.9%
9/152
|
|
Vascular disorders
Hypertension
|
5.4%
8/148
|
4.7%
7/149
|
3.3%
5/152
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER