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Patient's disease progressed and Vision Dropped which led to exit from the study
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| Name | Class |
|---|---|
| Juvenile Diabetes Research Foundation | OTHER |
| iCo Therapeutics Inc. | INDUSTRY |
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Drug: 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 | Experimental | Drug: 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 | Experimental | Drug: 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 |
|
| Group 4 | Experimental | Drug: Ranibizumab and 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iCo-007 350 mcg | Drug | iCo-007 (350 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (350 μg) at month 4 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in VA From Baseline to Month 8 | The primary efficacy variable is the change in visual acuity (mean change in number of letters) from baseline to month 8 | Baseline to month 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants in a Given Study Arm Experiencing the Same Drug-related Serious Adverse Event as a Measure of Safety and Tolerability | 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; |
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Inclusion Criteria:
Age ≥18 years
Have diabetes mellitus type I or II (insulin or non-insulin dependent) with HbA1c ≥5.5% and HbA1c ≤13%; have non-proliferative diabetic retinopathy, or inactive proliferative diabetic retinopathy, or proliferative diabetic retinopathy with a reasonable expectation that panretinal photocoagulation will not be required during the study follow-up period
Have diabetic macular edema with central subfield thickness of ≥250 microns (confirmed by Stratus Time-Domain(TD) OCT
Have best corrected visual acuity (ETDRS) that is Snellen equivalent of
Be willing and able to sign an approved written informed consent. If a patient has a central nervous system disorder (i.e. dementia) that will not allow him/her to understand the consent independently, the patient will not be allowed to join the study
Be able to attend all scheduled study visits
Women who are not lactating or pregnant and are willing to use adequate contraception during the study period, if appropriate
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Diana V. Do, MD | Stanley M Truhlsen Eye Institute, University of Nebraska Medical Center | Principal Investigator |
| Robert Wong, MD | Austin Retina Associates | Principal Investigator |
| Michael J. Tolentino, MD | Center for Retina Macula Disease | Principal Investigator |
| Prema Abraham, MD | Black Hills Regional Eye Institute | Principal Investigator |
| Eugene Lit, MD | East Bay Retina Institute | Principal Investigator |
| Michael J. Elman, MD | Elman Retina Group | Principal Investigator |
| Thomas A. Barnard, MD | Florida Retina Institute | Principal Investigator |
| Thomas A. Ciulla, MD | Midwest Eye Institute | Principal Investigator |
| Richard B. Rosen, MD | New York Eye and Ear Infirmary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanley M Truhlsen Eye Institute | Omaha | Nebraska | 68198-5540 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| iCo-007 700 mcg | Drug | 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 | Drug | 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 | Drug | 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 |
|
|
| Baseline to month 8 |
| Change in VA From Baseline to Month 12 | The primary efficacy variable is the change in visual acuity (mean change in number of letters) from baseline to month 12 | Baseline to month 12 |
| Change in Retinal Thickness Measured by OCT From Baseline to Month 8 | Group 1 | Baseline to month 8 |
| Change in Retinal Thickness Measured | measured by OCT | Baseline to month 12 |
| Duration of iCo-007 Treatment Effect | treatment effect as measured by VA and OCY thickness | Baseline to month 12 |
| Peak Plasma Concentration (Cmax)of iCo-007 After Multiple Injections | cmax | Baseline to month 12 |
| Henry L. Hudson, MD |
| Retina Centers, P.C. |
| Principal Investigator |
| Pravin Dugel, MD | Retina Consultants of Arizona | Principal Investigator |
| Gregg T. Kokame, MD | Retina Consultants of Hawaii, Pali Momi Medical Center | Principal Investigator |
| David M. Brown, MD | Retina Consultants Houston | Principal Investigator |
| Larry S. Halperin, MD | Retina Group of Florida | Principal Investigator |
| Goergios Papastergio, MD | Retina Institute of Hawaii | Principal Investigator |
| Ron P. Gallemore, MD. PhD | Retina Macula Institute | Principal Investigator |
| Brian B. Berger, MD | Retina Research Center | Principal Investigator |
| Homayoun Tabandeh, MD | Retina Vitreous Associates | Principal Investigator |
| Dennis M. Marcus, MD | Southeast Retina | Principal Investigator |
| Robert S. Wirthlin, MD | Spokane Eye Clinic | Principal Investigator |
| David Callanan, MD | Texas Retina Associates in Arlington | Principal Investigator |
| Karl G. Csaky, MD, PhD | Texas Retina Associates in Dallas | Principal Investigator |
| Surendar Purohit, MD | TLC Eye Care & Laser Center | Principal Investigator |
| Victor H. Gonzalez, MD | Valley Retina Institute | Principal Investigator |
| Louis Glazer, MD | Vitreo-Retinal Associates | Principal Investigator |
| Dean Eliott, MD | Massachusetts Eye and Ear Infirmary, Harvard Medical School | Principal Investigator |
| FG002 | 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 |
| FG003 | 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 |
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 | 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 |
| BG001 | Group 2 | 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 |
| BG002 | Group 3 | 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 |
| BG003 | Group 4 | 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 |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Baseline Best Corrected Visual Acuity (BCVA) | Mean | Standard Deviation | Letters |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in VA From Baseline to Month 8 | The primary efficacy variable is the change in visual acuity (mean change in number of letters) from baseline to month 8 | The results are from the participants which completed the primary end point and for which the data is available. | Posted | Mean | Standard Deviation | Letters | Baseline to month 8 |
|
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants in a Given Study Arm Experiencing the Same Drug-related Serious Adverse Event as a Measure of Safety and Tolerability | 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; | Posted | Count of Participants | Participants | Baseline to month 8 |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Change in VA From Baseline to Month 12 | The primary efficacy variable is the change in visual acuity (mean change in number of letters) from baseline to month 12 | The study was terminated prior to month 12. No data was collected and 0 participants were analyzed at month 12 | Posted | Baseline to month 12 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Retinal Thickness Measured by OCT From Baseline to Month 8 | Group 1 | Some participants opted out of the month 8 OCT. | Posted | Mean | Standard Deviation | microns | Baseline to month 8 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change in Retinal Thickness Measured | measured by OCT | The study was terminated prior to month 12. No data was collected and 0 participants were analyzed at month 12 | Posted | Baseline to month 12 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of iCo-007 Treatment Effect | treatment effect as measured by VA and OCY thickness | The study was terminated prior to month 12. No data was collected and 0 participants were analyzed at month 12 | Posted | Baseline to month 12 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Peak Plasma Concentration (Cmax)of iCo-007 After Multiple Injections | cmax | The study was terminated prior to month 12. No data was collected and 0 participants were analyzed at month 12 | Posted | Baseline to month 12 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1 | 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 | 0 | 47 | 5 | 47 | 32 | 47 |
| EG001 | Group 2 | 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 | 0 | 46 | 9 | 46 | 35 | 46 |
| EG002 | Group 3 | 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 | 1 | 47 | 5 | 47 | 36 | 47 |
| EG003 | Group 4 | 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 | 0 | 45 | 15 | 45 | 35 | 45 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ocular Adverse Events | Eye disorders | Non-systematic Assessment |
| ||
| Non-Ocular Adverse Events | General disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Other Adverse Events - Ocular | Eye disorders | Non-systematic Assessment |
| ||
| Other Adverse Events - Systemic | General disorders | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Quan Dong Nguyen | University of Nebraska | 4025592020 | quan.nguyen@unmc.edu |
| ID | Term |
|---|---|
| D007834 | Lasers |
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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| Male |
|
| OG003 |
| Group 4 |
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 |
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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 |
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