ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 2 for:    iCo-007

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) (iDEAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01565148
Recruitment Status : Terminated (Patient's disease progressed and Vision Dropped which led to exit from the study)
First Posted : March 28, 2012
Results First Posted : August 30, 2017
Last Update Posted : August 30, 2017
Sponsor:
Collaborators:
Juvenile Diabetes Research Foundation
iCo Therapeutics Inc.
Information provided by (Responsible Party):
Johns Hopkins University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Diabetic Macular Edema
Interventions Drug: iCo-007 350 mcg
Drug: iCo-007 700 mcg
Drug: iCo-007 350 mcg and Laser
Drug: Ranibizumab and iCo-007 350 mcg
Enrollment 185

Recruitment Details  
Pre-assignment Details  
Arm/Group Title iCo-007 350 mcg iCo-007 700 mcg iCo-007 350 mcg and Laser Ranibizumab and iCo-007 350 mcg
Hide Arm/Group Description 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 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 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 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
Period Title: Overall Study
Started 47 46 47 45
Completed 32 31 40 32
Not Completed 15 15 7 13
Reason Not Completed
Withdrawal by Subject             1             1             1             2
Lost to Follow-up             4             4             0             3
Rescue Therapy             8             5             5             8
Death             0             0             1             0
Physician Decision             2             5             0             0
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Total
Hide Arm/Group Description 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 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (700 μg) at month 4 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 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 of all reporting groups
Overall Number of Baseline Participants 47 46 47 45 185
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 47 participants 46 participants 47 participants 45 participants 185 participants
63.4  (8.91) 62.8  (9.7) 61.4  (9.72) 61.2  (7.29) 62.2  (8.95)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 46 participants 47 participants 45 participants 185 participants
Female
27
  57.4%
19
  41.3%
20
  42.6%
17
  37.8%
83
  44.9%
Male
20
  42.6%
27
  58.7%
27
  57.4%
28
  62.2%
102
  55.1%
Baseline Best Corrected Visual Acuity (BCVA)  
Mean (Standard Deviation)
Unit of measure:  Letters
Number Analyzed 47 participants 46 participants 47 participants 45 participants 185 participants
57.9  (12.3) 58.7  (12.49) 59.8  (13.78) 61.5  (14.03) 59.3  (13.15)
1.Primary Outcome
Title Change in VA From Baseline to Month 8
Hide Description The primary efficacy variable is the change in visual acuity (mean change in number of letters) from baseline to month 8
Time Frame Baseline to month 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The results are from the participants which completed the primary end point and for which the data is available.
Arm/Group Title Group 1 Group 2 Group 3 Group 4
Hide Arm/Group Description:
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 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (700 μg) at month 4
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
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 Number of Participants Analyzed 28 26 36 29
Mean (Standard Deviation)
Unit of Measure: Letters
-12.07  (18.20) -24.46  (24.02) -15.22  (24.62) -18.28  (30.45)
2.Secondary Outcome
Title Number of Participants in a Given Study Arm Experiencing the Same Drug-related Serious Adverse Event as a Measure of Safety and Tolerability
Hide Description Safety 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;
Time Frame Baseline to month 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1 Group 2 Group 3 Group 4
Hide Arm/Group Description:
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 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (700 μg) at month 4
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
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 Number of Participants Analyzed 47 46 47 45
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
3.Secondary Outcome
Title Change in VA From Baseline to Month 12
Hide Description The primary efficacy variable is the change in visual acuity (mean change in number of letters) from baseline to month 12
Time Frame Baseline to month 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The study was terminated prior to month 12. No data was collected and 0 participants were analyzed at month 12
Arm/Group Title iCo-007 350 mcg iCo-007 700 mcg iCo-007 350 mcg and Laser Ranibizumab and iCo-007 350 mcg
Hide Arm/Group Description:
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 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 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 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 Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Change in Retinal Thickness Measured by OCT From Baseline to Month 8
Hide Description Group 1
Time Frame Baseline to month 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Some participants opted out of the month 8 OCT.
Arm/Group Title Group 1 Group 2 Group 3 Group 4
Hide Arm/Group Description:
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 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (700 μg) at month 4
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
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 Number of Participants Analyzed 25 22 29 22
Mean (Standard Deviation)
Unit of Measure: microns
-70.68  (176.31) -160.22  (177.36) -54.17  (125.35) -92.10  (185.49)
5.Secondary Outcome
Title Change in Retinal Thickness Measured
Hide Description measured by OCT
Time Frame Baseline to month 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The study was terminated prior to month 12. No data was collected and 0 participants were analyzed at month 12
Arm/Group Title iCo-007 350 mcg iCo-007 700 mcg iCo-007 350 mcg and Laser Ranibizumab and iCo-007 350 mcg
Hide Arm/Group Description:
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 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 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 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 Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Duration of iCo-007 Treatment Effect
Hide Description treatment effect as measured by VA and OCY thickness
Time Frame Baseline to month 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The study was terminated prior to month 12. No data was collected and 0 participants were analyzed at month 12
Arm/Group Title iCo-007 350 mcg iCo-007 700 mcg iCo-007 350 mcg and Laser Ranibizumab and iCo-007 350 mcg
Hide Arm/Group Description:
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 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 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 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 Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Peak Plasma Concentration (Cmax)of iCo-007 After Multiple Injections
Hide Description cmax
Time Frame Baseline to month 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The study was terminated prior to month 12. No data was collected and 0 participants were analyzed at month 12
Arm/Group Title iCo-007 350 mcg iCo-007 700 mcg iCo-007 350 mcg and Laser Ranibizumab and iCo-007 350 mcg
Hide Arm/Group Description:
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 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 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 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 Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 1 Group 2 Group 3 Group 4
Hide Arm/Group Description 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 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (700 μg) at month 4 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 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
All-Cause Mortality
Group 1 Group 2 Group 3 Group 4
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/47 (0.00%)      0/46 (0.00%)      1/47 (2.13%)      0/45 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Group 1 Group 2 Group 3 Group 4
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/47 (10.64%)      9/46 (19.57%)      5/47 (10.64%)      15/45 (33.33%)    
Eye disorders         
Ocular Adverse Events *  2/47 (4.26%)  2 4/46 (8.70%)  4 3/47 (6.38%)  3 7/45 (15.56%)  7
General disorders         
Non-Ocular Adverse Events *  3/47 (6.38%)  3 5/46 (10.87%)  5 2/47 (4.26%)  2 8/45 (17.78%)  8
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group 1 Group 2 Group 3 Group 4
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   32/47 (68.09%)      35/46 (76.09%)      36/47 (76.60%)      35/45 (77.78%)    
Eye disorders         
Other Adverse Events - Ocular *  28/47 (59.57%)  107 32/46 (69.57%)  119 29/47 (61.70%)  88 34/45 (75.56%)  99
General disorders         
Other Adverse Events - Systemic *  20/47 (42.55%)  58 23/46 (50.00%)  63 23/47 (48.94%)  45 22/45 (48.89%)  69
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Name/Title: Quan Dong Nguyen
Organization: University of Nebraska
Phone: 4025592020
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01565148     History of Changes
Other Study ID Numbers: 2010-007-03-DME
First Submitted: March 15, 2012
First Posted: March 28, 2012
Results First Submitted: October 11, 2016
Results First Posted: August 30, 2017
Last Update Posted: August 30, 2017