Diabetic Macular EdemaPhase 2iDEALNCT01565148

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)

A Phase 2 study testing iCo-007 350 mcg, iCo-007 700 mcg and iCo-007 350 mcg and Laser in people with Diabetic Macular Edema, run by Johns Hopkins University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

To assess the safety of repeated iCo-007 intravitreal injections in treatment of subjects with diabetic macular edema as monotherapy and in combination with ranibizumab or laser photocoagulation To assess the change in visual acuity and retinal thickness on optical coherence tomography (OCT) from baseline to month 8… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetic Macular Edema
What is being tested?: iCo-007 350 mcg, iCo-007 700 mcg and iCo-007 350 mcg and Laser
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 185 participants
Where: 1 siteUnited States
Study dates: Feb 2012to Oct 2014
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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
20/32 and ≥20/320, inclusive
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

Who cannot join

Have macular or perimacular edema secondary to an etiology other than diabetes
Have concurrent retinal diseases other than diabetic retinopathy
Have additional ocular diseases compromising visual acuity and/or interfering with study assessments; patients who have glaucoma but deemed stable (intraocular pressure ≤ 25 mmHg at screening) on medications or status post surgery, may participate in the study
Participant has a history of prior pars plana vitrectomy
Subjects with significant cataract or or posterior capsular opacification that may need intervention within one year or vitreous opacity that hinder study assessment (i.e.fundus examination) which requires intervention within a year
Subjects who have DME with severe capillary non-perfusion (avascular zone diameter >1,000 microns)

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Have an allergy to fluorescein dye
Have terminal renal disease (on active kidney dialysis), cerebral vascular accident(including TIA), myocardial infarction or congestive heart disease within 6 months of study enrollment, liver damage (2x upper limit of normal range for aspartate aminotransferase (AST), Alanine aminotransferase (ALT) or total bilirubin). Patients who may have received renal transplant in the past and now have stable renal function, may participate in the study
Subjects with systolic blood pressure higher than 180 mm Hg or diastolic above 100 mm Hg, with or without anti-hypertensive treatment
Have a history of panretinal photocoagulation (PRP) in the study eye within 3 months of study entry or are likely to have PRP in the study eye during study participation
Had macular photocoagulation or ocular surgery within 3 months of study entry in the study eye
Received intraocular or periocular injection of steroids in the study eye (e.g., triamcinolone) within 3 months of study entry or anti-angiogenic drugs (pegaptanib sodium, ranibizumab, bevacizumab, VEGF-TRAP, protein kinase C inhibitor, etc.) within 2 months of study entry; history of usage of topical or systemic steroids within 3 months of study entry is not an exclusion

Trial locations and contacts

1 site in 1 country.

United States1 site

Stanley M Truhlsen Eye Institute
Omaha, Nebraska, 68198-5540

Other trials in United States

About this study

Official title: 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 With Involvement of the FoveAL Center (the iDEAL Study)

To assess the safety of repeated iCo-007 intravitreal injections in treatment of subjects with diabetic macular edema as monotherapy and in combination with ranibizumab or laser photocoagulation
To assess the change in visual acuity and retinal thickness on optical coherence tomography (OCT) from baseline to month 8 and month 12

Conditions: Diabetic Macular Edema
Being tested: iCo-007 350 mcg, iCo-007 700 mcg, iCo-007 350 mcg and Laser, Ranibizumab and iCo-007 350 mcg
Keywords: Diabetic Macular Edema (DME)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

iCo-007 350 mcgDrug
Also called Group 1
iCo-007 (350 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (350 μg) at month 4
iCo-007 700 mcgDrug
Also called Group 2
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 LaserDrug
Also called Group 3
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 mcgDrug
Also called Group 4
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

Study groups in NCT01565148
Study group	Role	What they receive
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 Receives: Drug: iCo-007 350 mcg
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 Receives: Drug: iCo-007 700 mcg
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 Receives: Drug: iCo-007 350 mcg and Laser
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 Receives: Drug: Ranibizumab and iCo-007 350 mcg

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Baseline to month 8

Secondary outcomes (6)

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;
Measured: 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
Measured: Baseline to month 12
Change in Retinal Thickness Measured by OCT From Baseline to Month 8
Group 1
Measured: Baseline to month 8
Change in Retinal Thickness Measured
measured by OCT
Measured: Baseline to month 12
Duration of iCo-007 Treatment Effect
treatment effect as measured by VA and OCY thickness
Measured: Baseline to month 12
Peak Plasma Concentration (Cmax)of iCo-007 After Multiple Injections
cmax
Measured: Baseline to month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2012Oct 2014

First posted28 Mar 2012 (estimated)
Study startFeb 2012
Primary completionFeb 2014
Study completionOct 2014

Why it stopped: Patient's disease progressed and Vision Dropped which led to exit from the study

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Diabetic Macular EdemaStudies of the same condition, open and under way.
More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Enrolment: 185 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01565148
Sponsor's protocol ID: 2010-007-03-DME
Acronym: iDEAL
Status last verified: Jul 2017
First submitted: 15 Mar 2012
Last updated: 30 Aug 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2/3
A Study of 2 Doses of Remigromig (EYE103) Compared With Ranibizumab (0.5 mg) in Participants With DME
Diabetic Macular Edema (DME)
RecruitingPhase 3
A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME).
Diabetic Macular Edema (DME)
RecruitingPhase 2/3
Surabgene Lomparvovec Administered in the Suprachoroidal Space in Adult Participants With Diabetic Retinopathy Without Center-Involved Diabetic Macular Edema
Diabetic Retinopathy
RecruitingPhase 2
A Randomized, Phase 2 Study of Oral BGE-102 in Participants With Center-Involved Diabetic Macular Edema
Diabetic Macular Edema (DME)
Active, not recruitingObservational study
Long-Term Follow-up Study of ADVM-022 in DME (INFINITY-EXT)
Diabetic Macular Edema, Diabetic Retinopathy

All Diabetic Macular Edema trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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 With Involvement of the FoveAL Center (the iDEAL Study)
ClinicalTrials.gov ID: NCT01565148
Acronym / sponsor ID: iDEAL / 2010-007-03-DME
Conditions: Diabetic Macular Edema
Keywords: Diabetic Macular Edema (DME)
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Patient's disease progressed and Vision Dropped which led to exit from the study
Enrolment: 185 participants (actual)
Lead sponsor: Johns Hopkins UniversityUniversity, hospital or other
Collaborators: Juvenile Diabetes Research Foundation, iCo Therapeutics Inc.
Study start: Feb 2012 (actual)
Primary completion: Feb 2014 (actual)
Study completion: Oct 2014 (actual)
First posted: 28 Mar 2012 (estimated)
Results: Posted 30 Aug 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To assess the safety of repeated iCo-007 intravitreal injections in treatment of subjects with diabetic macular edema as monotherapy and in combination with ranibizumab or laser photocoagulation
To assess the change in visual acuity and retinal thickness on optical coherence tomography (OCT) from baseline to month 8 and month 12

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Group 1	Experimental	Drug: iCo-007 350 mcgDrug: 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 mcgDrug: 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 LaserDrug: 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 mcgDrug: 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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (12 listed)

Have macular or perimacular edema secondary to an etiology other than diabetes
Have concurrent retinal diseases other than diabetic retinopathy
Have additional ocular diseases compromising visual acuity and/or interfering with study assessments; patients who have glaucoma but deemed stable (intraocular pressure ≤ 25 mmHg at screening) on medications or status post surgery, may participate in the study
Participant has a history of prior pars plana vitrectomy
Subjects with significant cataract or or posterior capsular opacification that may need intervention within one year or vitreous opacity that hinder study assessment (i.e.fundus examination) which requires intervention within a year

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
iCo-007 350 mcgAlso: Group 1iCo-007 (350 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (350 μg) at month 4	Drug	Group 1
iCo-007 700 mcgAlso: Group 2iCo-007 (700 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (700 μg) at month 4	Drug	Group 2
iCo-007 350 mcg and LaserAlso: Group 3iCo-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	Drug	Group 3
Ranibizumab and iCo-007 350 mcgAlso: Group 4Ranibizumab (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	Drug	Group 4

Primary outcome

Change in VA From Baseline to Month 8
Time frame: 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

6 secondary outcomes

Number of Participants in a Given Study Arm Experiencing the Same Drug-related Serious Adverse Event as a Measure of Safety and Tolerability
Time frame: Baseline to month 8
Change in VA From Baseline to Month 12
Time frame: Baseline to month 12
Change in Retinal Thickness Measured by OCT From Baseline to Month 8
Time frame: Baseline to month 8
Change in Retinal Thickness Measured
Time frame: Baseline to month 12
Duration of iCo-007 Treatment Effect
Time frame: Baseline to month 12
Peak Plasma Concentration (Cmax)of iCo-007 After Multiple Injections
Time frame: Baseline to month 12

Results and safety

Results posted to the registry on 30 Aug 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
iCo-007 350 mcg	47	32
iCo-007 700 mcg	46	31
iCo-007 350 mcg and Laser	47	40
Ranibizumab and iCo-007 350 mcg	45	32

Primary outcome: Change in VA From Baseline to Month 8

Time frame: Baseline to month 8. Mean (Standard Deviation). Unit: Letters

Measure	Group 1 n = 28	Group 2 n = 26	Group 3 n = 36	Group 4 n = 29
Value	-12.07 (18.20)	-24.46 (24.02)	-15.22 (24.62)	-18.28 (30.45)

Population analysed: The results are from the participants which completed the primary end point and for which the data is available.

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1	5 of 47 (10.6%)	32 of 47 (68.1%)	0 of 47
Group 2	9 of 46 (19.6%)	35 of 46 (76.1%)	0 of 46
Group 3	5 of 47 (10.6%)	36 of 47 (76.6%)	1 of 47
Group 4	15 of 45 (33.3%)	35 of 45 (77.8%)	0 of 45

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Diabetic Macular Edema

Active, not recruitingPhase 2/3
A Study of 2 Doses of Remigromig (EYE103) Compared With Ranibizumab (0.5 mg) in Participants With DME
Diabetic Macular Edema (DME)
RecruitingPhase 3
A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME).
Diabetic Macular Edema (DME)
RecruitingPhase 2/3
Surabgene Lomparvovec Administered in the Suprachoroidal Space in Adult Participants With Diabetic Retinopathy Without Center-Involved Diabetic Macular Edema
Diabetic Retinopathy
RecruitingPhase 2
A Randomized, Phase 2 Study of Oral BGE-102 in Participants With Center-Involved Diabetic Macular Edema
Diabetic Macular Edema (DME)
Active, not recruitingObservational study
Long-Term Follow-up Study of ADVM-022 in DME (INFINITY-EXT)
Diabetic Macular Edema, Diabetic Retinopathy

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Diana V. Do, MD principal investigator

Stanley M Truhlsen Eye Institute, University of Nebraska Medical Center

Robert Wong, MD principal investigator

Austin Retina Associates

Michael J. Tolentino, MD principal investigator

Center for Retina Macula Disease

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing iCo-007 350 mcg, iCo-007 700 mcg and iCo-007 350 mcg and Laser in people with Diabetic Macular Edema, run by Johns Hopkins University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in VA From Baseline to Month 8 (time frame: Baseline to month 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01565148.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2017.