Trial Outcomes & Findings for A Randomized, Multi-center, Phase II Study of the Safety, Tolerability and Bioactivity of Repeated Intravitreal Injections of iCo-007 as Monotherapy or in Combination With Ranibizumab or Laser Photocoagulation in the Treatment of Diabetic Macular Edema (the iDEAL Study) (NCT NCT01565148)
NCT ID: NCT01565148
Last Updated: 2017-08-30
Results Overview
The primary efficacy variable is the change in visual acuity (mean change in number of letters) from baseline to month 8
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
185 participants
Primary outcome timeframe
Baseline to month 8
Results posted on
2017-08-30
Participant Flow
Participant milestones
| Measure |
iCo-007 350 mcg
iCo-007 350 mcg: iCo-007 (350 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (350 μg) at month 4
|
iCo-007 700 mcg
iCo-007 700 mcg: iCo-007 (700 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (700 μg) at month 4
|
iCo-007 350 mcg and Laser
iCo-007 350 mcg and Laser: iCo-007 (350 μg) as an intravitreal injection at baseline followed 7 days later by laser photocoagulation. At M4, intravitreal injection of iCo-007 (350 μg) will be given as mandatory treatment. If the eye also meets retreatment criteria, it will also receive the second laser photocoagulation
|
Ranibizumab and iCo-007 350 mcg
Ranibizumab Plus iCo-007 350 mcg: Ranibizumab (0.5 mg) intravitreal injection at baseline followed by iCo-007 (350 μg) intravitreal injection 2 weeks later; re-treatment with ranibizumab (0.5 mg) mandatory at M4 followed by iCo-007 (350 μg) 2 weeks later
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
47
|
46
|
47
|
45
|
|
Overall Study
COMPLETED
|
32
|
31
|
40
|
32
|
|
Overall Study
NOT COMPLETED
|
15
|
15
|
7
|
13
|
Reasons for withdrawal
| Measure |
iCo-007 350 mcg
iCo-007 350 mcg: iCo-007 (350 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (350 μg) at month 4
|
iCo-007 700 mcg
iCo-007 700 mcg: iCo-007 (700 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (700 μg) at month 4
|
iCo-007 350 mcg and Laser
iCo-007 350 mcg and Laser: iCo-007 (350 μg) as an intravitreal injection at baseline followed 7 days later by laser photocoagulation. At M4, intravitreal injection of iCo-007 (350 μg) will be given as mandatory treatment. If the eye also meets retreatment criteria, it will also receive the second laser photocoagulation
|
Ranibizumab and iCo-007 350 mcg
Ranibizumab Plus iCo-007 350 mcg: Ranibizumab (0.5 mg) intravitreal injection at baseline followed by iCo-007 (350 μg) intravitreal injection 2 weeks later; re-treatment with ranibizumab (0.5 mg) mandatory at M4 followed by iCo-007 (350 μg) 2 weeks later
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
4
|
4
|
0
|
3
|
|
Overall Study
Rescue Therapy
|
8
|
5
|
5
|
8
|
|
Overall Study
Death
|
0
|
0
|
1
|
0
|
|
Overall Study
Physician Decision
|
2
|
5
|
0
|
0
|
Baseline Characteristics
A Randomized, Multi-center, Phase II Study of the Safety, Tolerability and Bioactivity of Repeated Intravitreal Injections of iCo-007 as Monotherapy or in Combination With Ranibizumab or Laser Photocoagulation in the Treatment of Diabetic Macular Edema (the iDEAL Study)
Baseline characteristics by cohort
| Measure |
Group 1
n=47 Participants
iCo-007 350 mcg: iCo-007 (350 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (350 μg) at month 4
|
Group 2
n=46 Participants
iCo-007 700 mcg: iCo-007 (700 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (700 μg) at month 4
|
Group 3
n=47 Participants
iCo-007 350 mcg Plus Laser: iCo-007 (350 μg) as an intravitreal injection at baseline followed 7 days later by laser photocoagulation. At M4, intravitreal injection of iCo-007 (350 μg) will be given as mandatory treatment. If the eye also meets retreatment criteria, it will also receive the second laser photocoagulation
|
Group 4
n=45 Participants
Ranibizumab Plus iCo-007 350 mcg: Ranibizumab (0.5 mg) intravitreal injection at baseline followed by iCo-007 (350 μg) intravitreal injection 2 weeks later; re-treatment with ranibizumab (0.5 mg) mandatory at M4 followed by iCo-007 (350 μg) 2 weeks later
|
Total
n=185 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
63.4 years
STANDARD_DEVIATION 8.91 • n=99 Participants
|
62.8 years
STANDARD_DEVIATION 9.7 • n=107 Participants
|
61.4 years
STANDARD_DEVIATION 9.72 • n=206 Participants
|
61.2 years
STANDARD_DEVIATION 7.29 • n=7 Participants
|
62.2 years
STANDARD_DEVIATION 8.95 • n=31 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
17 Participants
n=7 Participants
|
83 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
28 Participants
n=7 Participants
|
102 Participants
n=31 Participants
|
|
Baseline Best Corrected Visual Acuity (BCVA)
|
57.9 Letters
STANDARD_DEVIATION 12.3 • n=99 Participants
|
58.7 Letters
STANDARD_DEVIATION 12.49 • n=107 Participants
|
59.8 Letters
STANDARD_DEVIATION 13.78 • n=206 Participants
|
61.5 Letters
STANDARD_DEVIATION 14.03 • n=7 Participants
|
59.3 Letters
STANDARD_DEVIATION 13.15 • n=31 Participants
|
PRIMARY outcome
Timeframe: Baseline to month 8Population: The results are from the participants which completed the primary end point and for which the data is available.
The primary efficacy variable is the change in visual acuity (mean change in number of letters) from baseline to month 8
Outcome measures
| Measure |
Group 1
n=28 Participants
iCo-007 350 mcg: iCo-007 (350 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (350 μg) at month 4
|
Group 2
n=26 Participants
iCo-007 700 mcg: iCo-007 (700 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (700 μg) at month 4
|
Group 3
n=36 Participants
iCo-007 350 mcg Plus Laser: iCo-007 (350 μg) as an intravitreal injection at baseline followed 7 days later by laser photocoagulation. At M4, intravitreal injection of iCo-007 (350 μg) will be given as mandatory treatment. If the eye also meets retreatment criteria, it will also receive the second laser photocoagulation
|
Group 4
n=29 Participants
Ranibizumab Plus iCo-007 350 mcg: Ranibizumab (0.5 mg) intravitreal injection at baseline followed by iCo-007 (350 μg) intravitreal injection 2 weeks later; re-treatment with ranibizumab (0.5 mg) mandatory at M4 followed by iCo-007 (350 μg) 2 weeks later
|
|---|---|---|---|---|
|
Change in VA From Baseline to Month 8
|
-12.07 Letters
Standard Deviation 18.20
|
-24.46 Letters
Standard Deviation 24.02
|
-15.22 Letters
Standard Deviation 24.62
|
-18.28 Letters
Standard Deviation 30.45
|
SECONDARY outcome
Timeframe: Baseline to month 8Safety of repeated iCo-007 intravitreal injections in treatment of subjects with Diabetic Macular Edema (DME) as monotherapy and in combination with ranibizumab or laser photocoagulation. Serious consideration will be given if 2 or more patients in a particular treatment arm experience the same drug-related serious adverse event;
Outcome measures
| Measure |
Group 1
n=47 Participants
iCo-007 350 mcg: iCo-007 (350 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (350 μg) at month 4
|
Group 2
n=46 Participants
iCo-007 700 mcg: iCo-007 (700 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (700 μg) at month 4
|
Group 3
n=47 Participants
iCo-007 350 mcg Plus Laser: iCo-007 (350 μg) as an intravitreal injection at baseline followed 7 days later by laser photocoagulation. At M4, intravitreal injection of iCo-007 (350 μg) will be given as mandatory treatment. If the eye also meets retreatment criteria, it will also receive the second laser photocoagulation
|
Group 4
n=45 Participants
Ranibizumab Plus iCo-007 350 mcg: Ranibizumab (0.5 mg) intravitreal injection at baseline followed by iCo-007 (350 μg) intravitreal injection 2 weeks later; re-treatment with ranibizumab (0.5 mg) mandatory at M4 followed by iCo-007 (350 μg) 2 weeks later
|
|---|---|---|---|---|
|
Number of Participants in a Given Study Arm Experiencing the Same Drug-related Serious Adverse Event as a Measure of Safety and Tolerability
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline to month 12Population: The study was terminated prior to month 12. No data was collected and 0 participants were analyzed at month 12
The primary efficacy variable is the change in visual acuity (mean change in number of letters) from baseline to month 12
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to month 8Population: Some participants opted out of the month 8 OCT.
Group 1
Outcome measures
| Measure |
Group 1
n=25 Participants
iCo-007 350 mcg: iCo-007 (350 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (350 μg) at month 4
|
Group 2
n=22 Participants
iCo-007 700 mcg: iCo-007 (700 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (700 μg) at month 4
|
Group 3
n=29 Participants
iCo-007 350 mcg Plus Laser: iCo-007 (350 μg) as an intravitreal injection at baseline followed 7 days later by laser photocoagulation. At M4, intravitreal injection of iCo-007 (350 μg) will be given as mandatory treatment. If the eye also meets retreatment criteria, it will also receive the second laser photocoagulation
|
Group 4
n=22 Participants
Ranibizumab Plus iCo-007 350 mcg: Ranibizumab (0.5 mg) intravitreal injection at baseline followed by iCo-007 (350 μg) intravitreal injection 2 weeks later; re-treatment with ranibizumab (0.5 mg) mandatory at M4 followed by iCo-007 (350 μg) 2 weeks later
|
|---|---|---|---|---|
|
Change in Retinal Thickness Measured by OCT From Baseline to Month 8
|
-70.68 microns
Standard Deviation 176.31
|
-160.22 microns
Standard Deviation 177.36
|
-54.17 microns
Standard Deviation 125.35
|
-92.10 microns
Standard Deviation 185.49
|
SECONDARY outcome
Timeframe: Baseline to month 12Population: The study was terminated prior to month 12. No data was collected and 0 participants were analyzed at month 12
measured by OCT
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to month 12Population: The study was terminated prior to month 12. No data was collected and 0 participants were analyzed at month 12
treatment effect as measured by VA and OCY thickness
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to month 12Population: The study was terminated prior to month 12. No data was collected and 0 participants were analyzed at month 12
cmax
Outcome measures
Outcome data not reported
Adverse Events
Group 1
Serious events: 5 serious events
Other events: 32 other events
Deaths: 0 deaths
Group 2
Serious events: 9 serious events
Other events: 35 other events
Deaths: 0 deaths
Group 3
Serious events: 5 serious events
Other events: 36 other events
Deaths: 1 deaths
Group 4
Serious events: 15 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1
n=47 participants at risk
iCo-007 350 mcg: iCo-007 (350 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (350 μg) at month 4
|
Group 2
n=46 participants at risk
iCo-007 700 mcg: iCo-007 (700 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (700 μg) at month 4
|
Group 3
n=47 participants at risk
iCo-007 350 mcg Plus Laser: iCo-007 (350 μg) as an intravitreal injection at baseline followed 7 days later by laser photocoagulation. At M4, intravitreal injection of iCo-007 (350 μg) will be given as mandatory treatment. If the eye also meets retreatment criteria, it will also receive the second laser photocoagulation
|
Group 4
n=45 participants at risk
Ranibizumab Plus iCo-007 350 mcg: Ranibizumab (0.5 mg) intravitreal injection at baseline followed by iCo-007 (350 μg) intravitreal injection 2 weeks later; re-treatment with ranibizumab (0.5 mg) mandatory at M4 followed by iCo-007 (350 μg) 2 weeks later
|
|---|---|---|---|---|
|
Eye disorders
Ocular Adverse Events
|
4.3%
2/47 • Number of events 2
|
8.7%
4/46 • Number of events 4
|
6.4%
3/47 • Number of events 3
|
15.6%
7/45 • Number of events 7
|
|
General disorders
Non-Ocular Adverse Events
|
6.4%
3/47 • Number of events 3
|
10.9%
5/46 • Number of events 5
|
4.3%
2/47 • Number of events 2
|
17.8%
8/45 • Number of events 8
|
Other adverse events
| Measure |
Group 1
n=47 participants at risk
iCo-007 350 mcg: iCo-007 (350 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (350 μg) at month 4
|
Group 2
n=46 participants at risk
iCo-007 700 mcg: iCo-007 (700 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (700 μg) at month 4
|
Group 3
n=47 participants at risk
iCo-007 350 mcg Plus Laser: iCo-007 (350 μg) as an intravitreal injection at baseline followed 7 days later by laser photocoagulation. At M4, intravitreal injection of iCo-007 (350 μg) will be given as mandatory treatment. If the eye also meets retreatment criteria, it will also receive the second laser photocoagulation
|
Group 4
n=45 participants at risk
Ranibizumab Plus iCo-007 350 mcg: Ranibizumab (0.5 mg) intravitreal injection at baseline followed by iCo-007 (350 μg) intravitreal injection 2 weeks later; re-treatment with ranibizumab (0.5 mg) mandatory at M4 followed by iCo-007 (350 μg) 2 weeks later
|
|---|---|---|---|---|
|
Eye disorders
Other Adverse Events - Ocular
|
59.6%
28/47 • Number of events 107
|
69.6%
32/46 • Number of events 119
|
61.7%
29/47 • Number of events 88
|
75.6%
34/45 • Number of events 99
|
|
General disorders
Other Adverse Events - Systemic
|
42.6%
20/47 • Number of events 58
|
50.0%
23/46 • Number of events 63
|
48.9%
23/47 • Number of events 45
|
48.9%
22/45 • Number of events 69
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place