Trial Outcomes & Findings for Safety and Efficacy of ATG003 in Patients With Wet Age-Related Macular Degeneration (AMD) (NCT NCT00414206)
NCT ID: NCT00414206
Last Updated: 2010-11-23
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
343 participants
Primary outcome timeframe
Baseline to Week 48
Results posted on
2010-11-23
Participant Flow
Participant milestones
| Measure |
1% Mecamylamine
|
0.3% Mecamylamine
|
Placebo
|
|---|---|---|---|
|
Overall Study
STARTED
|
115
|
114
|
114
|
|
Overall Study
COMPLETED
|
57
|
58
|
59
|
|
Overall Study
NOT COMPLETED
|
58
|
56
|
55
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of ATG003 in Patients With Wet Age-Related Macular Degeneration (AMD)
Baseline characteristics by cohort
| Measure |
1% Mecamylamine
n=115 Participants
|
0.3% Mecamylamine
n=114 Participants
|
Placebo
n=114 Participants
|
Total
n=343 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
73.2 years
STANDARD_DEVIATION 8 • n=5 Participants
|
72.6 years
STANDARD_DEVIATION 8.7 • n=7 Participants
|
71.3 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
72.4 years
STANDARD_DEVIATION 8.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
213 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
130 Participants
n=4 Participants
|
|
Region of Enrollment
Czech Republic
|
11 participants
n=5 Participants
|
15 participants
n=7 Participants
|
12 participants
n=5 Participants
|
38 participants
n=4 Participants
|
|
Region of Enrollment
Mexico
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
6 participants
n=5 Participants
|
20 participants
n=4 Participants
|
|
Region of Enrollment
Brazil
|
15 participants
n=5 Participants
|
13 participants
n=7 Participants
|
16 participants
n=5 Participants
|
44 participants
n=4 Participants
|
|
Region of Enrollment
Poland
|
19 participants
n=5 Participants
|
21 participants
n=7 Participants
|
17 participants
n=5 Participants
|
57 participants
n=4 Participants
|
|
Region of Enrollment
Ukraine
|
34 participants
n=5 Participants
|
32 participants
n=7 Participants
|
35 participants
n=5 Participants
|
101 participants
n=4 Participants
|
|
Region of Enrollment
Russian Federation
|
26 participants
n=5 Participants
|
26 participants
n=7 Participants
|
28 participants
n=5 Participants
|
80 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
3 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 48Population: A modified MITT population was used, which was prospectively defined as all randomized patients who received at least one dose of study drug and had at least one post-baseline efficacy (visual acuity) assessment.
Outcome measures
| Measure |
1% Mecamylamine
n=113 Participants
|
0.3% Mecamylamine
n=112 Participants
|
Placebo
n=113 Participants
|
|---|---|---|---|
|
Proportion of Subjects Losing Fewer Than 15 ETDRS Letters of Visual Acuity at 48 Weeks Compared to Baseline.
|
88 Percent of subjects
|
86 Percent of subjects
|
92 Percent of subjects
|
Adverse Events
1% Mecamylamine
Serious events: 8 serious events
Other events: 68 other events
Deaths: 0 deaths
0.3% Mecamylamine
Serious events: 8 serious events
Other events: 57 other events
Deaths: 0 deaths
Placebo
Serious events: 7 serious events
Other events: 57 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1% Mecamylamine
n=115 participants at risk
|
0.3% Mecamylamine
n=114 participants at risk；n=115 participants at risk
|
Placebo
n=114 participants at risk
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/115
|
0.87%
1/115 • Number of events 1
|
0.00%
0/114
|
|
Cardiac disorders
Atrial fibrillation
|
0.87%
1/115 • Number of events 1
|
0.87%
1/115 • Number of events 1
|
0.00%
0/114
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/115
|
0.00%
0/115
|
0.88%
1/114 • Number of events 1
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/115
|
0.87%
1/115 • Number of events 1
|
0.00%
0/114
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/115
|
0.87%
1/115 • Number of events 1
|
0.00%
0/114
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/115
|
0.00%
0/115
|
0.88%
1/114 • Number of events 1
|
|
Eye disorders
Retinal haemorrhage
|
0.87%
1/115 • Number of events 1
|
0.87%
1/115 • Number of events 1
|
0.00%
0/114
|
|
Eye disorders
Retinal detachment
|
0.87%
1/115 • Number of events 1
|
0.00%
0/115
|
0.00%
0/114
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/115
|
0.87%
1/115 • Number of events 1
|
0.00%
0/114
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/115
|
0.00%
0/115
|
0.88%
1/114 • Number of events 1
|
|
General disorders
Duodenal ucler
|
0.00%
0/115
|
0.00%
0/115
|
0.88%
1/114 • Number of events 1
|
|
Gastrointestinal disorders
Reflux gastritis
|
0.00%
0/115
|
0.87%
1/115 • Number of events 1
|
0.00%
0/114
|
|
Hepatobiliary disorders
Cholelithiasis obstructive
|
0.00%
0/115
|
0.87%
1/115 • Number of events 1
|
0.00%
0/114
|
|
Infections and infestations
Pneumonia
|
0.00%
0/115
|
1.7%
2/115 • Number of events 2
|
0.00%
0/114
|
|
Infections and infestations
Diverticulitis
|
0.87%
1/115 • Number of events 1
|
0.00%
0/115
|
0.00%
0/114
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/115
|
0.00%
0/115
|
0.88%
1/114 • Number of events 1
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.87%
1/115 • Number of events 1
|
0.00%
0/115
|
0.00%
0/114
|
|
Nervous system disorders
Cerebrovascular accident
|
1.7%
2/115 • Number of events 2
|
0.00%
0/115
|
0.00%
0/114
|
|
Nervous system disorders
Cerebral infarction
|
0.87%
1/115 • Number of events 1
|
0.00%
0/115
|
0.00%
0/114
|
|
Renal and urinary disorders
Calculus bladder
|
0.00%
0/115
|
0.00%
0/115
|
0.88%
1/114 • Number of events 1
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/115
|
0.87%
1/115 • Number of events 1
|
0.00%
0/114
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/115
|
0.00%
0/115
|
0.88%
1/114 • Number of events 1
|
Other adverse events
| Measure |
1% Mecamylamine
n=115 participants at risk
|
0.3% Mecamylamine
n=114 participants at risk；n=115 participants at risk
|
Placebo
n=114 participants at risk
|
|---|---|---|---|
|
Cardiac disorders
Cardiac disorders
|
3.5%
4/115 • Number of events 4
|
7.0%
8/114 • Number of events 8
|
3.5%
4/114 • Number of events 4
|
|
Eye disorders
Visual acuity reduced
|
33.0%
38/115 • Number of events 38
|
27.2%
31/114 • Number of events 31
|
33.3%
38/114 • Number of events 38
|
|
Eye disorders
Retinal haemorrhage
|
14.8%
17/115 • Number of events 17
|
9.6%
11/114 • Number of events 11
|
14.0%
16/114 • Number of events 16
|
|
Eye disorders
Cataract
|
6.1%
7/115 • Number of events 7
|
0.00%
0/114
|
0.88%
1/114 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
7.8%
9/115 • Number of events 9
|
4.4%
5/114 • Number of events 5
|
7.0%
8/114 • Number of events 8
|
|
Infections and infestations
Infections and Infestiations
|
16.5%
19/115 • Number of events 19
|
14.0%
16/114 • Number of events 16
|
10.5%
12/114 • Number of events 12
|
|
Investigations
Investigations
|
3.5%
4/115 • Number of events 4
|
5.3%
6/114 • Number of events 6
|
6.1%
7/114 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
|
7.0%
8/115 • Number of events 8
|
4.4%
5/114 • Number of events 5
|
3.5%
4/114 • Number of events 4
|
|
Nervous system disorders
Nervous system disorders
|
13.0%
15/115 • Number of events 15
|
1.8%
2/114 • Number of events 2
|
7.9%
9/114 • Number of events 9
|
|
Nervous system disorders
Headache
|
5.2%
6/115 • Number of events 6
|
1.8%
2/114 • Number of events 2
|
3.5%
4/114 • Number of events 4
|
|
Vascular disorders
Vascular disorders
|
5.2%
6/115 • Number of events 6
|
2.6%
3/114 • Number of events 3
|
5.3%
6/114 • Number of events 6
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60