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 ID: NCT01565148

Last Updated: 2017-08-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 185 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2014-10-31

Brief 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 and month 12

Conditions

Diabetic Macular Edema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1

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 Type: EXPERIMENTAL

iCo-007 350 mcg

Intervention Type: DRUG

iCo-007 (350 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (350 μg) at month 4

Group 2

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 Type: EXPERIMENTAL

iCo-007 700 mcg

Intervention Type: DRUG

iCo-007 (700 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (700 μg) at month 4

Group 3

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 Type: EXPERIMENTAL

iCo-007 350 mcg and Laser

Intervention Type: 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

Group 4

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

Group Type: EXPERIMENTAL

Ranibizumab and iCo-007 350 mcg

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Group 1; Group 2; Group 3; Group 4

Eligibility Criteria

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

• 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

Exclusion Criteria

• 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)
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Juvenile Diabetes Research Foundation

OTHER

Sponsor Role: collaborator

iCo Therapeutics Inc.

INDUSTRY

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Diana V. Do, MD

Role: PRINCIPAL_INVESTIGATOR

Stanley M Truhlsen Eye Institute, University of Nebraska Medical Center

Robert Wong, MD

Role: PRINCIPAL_INVESTIGATOR

Austin Retina Associates

Michael J. Tolentino, MD

Role: PRINCIPAL_INVESTIGATOR

Center for Retina Macula Disease

Prema Abraham, MD

Role: PRINCIPAL_INVESTIGATOR

Black Hills Regional Eye Institute

Eugene Lit, MD

Role: PRINCIPAL_INVESTIGATOR

East Bay Retina Institute

Michael J. Elman, MD

Role: PRINCIPAL_INVESTIGATOR

Elman Retina Group

Thomas A. Barnard, MD

Role: PRINCIPAL_INVESTIGATOR

Florida Retina Institute

Thomas A. Ciulla, MD

Role: PRINCIPAL_INVESTIGATOR

Midwest Eye Institute

Richard B. Rosen, MD

Role: PRINCIPAL_INVESTIGATOR

New York Eye and Ear Infirmary

Henry L. Hudson, MD

Role: PRINCIPAL_INVESTIGATOR

Retina Centers, P.C.

Pravin Dugel, MD

Role: PRINCIPAL_INVESTIGATOR

Retina Consultants of Arizona

Gregg T. Kokame, MD

Role: PRINCIPAL_INVESTIGATOR

Retina Consultants of Hawaii, Pali Momi Medical Center

David M. Brown, MD

Role: PRINCIPAL_INVESTIGATOR

Retina Consultants Houston

Larry S. Halperin, MD

Role: PRINCIPAL_INVESTIGATOR

Retina Group of Florida

Goergios Papastergio, MD

Role: PRINCIPAL_INVESTIGATOR

Retina Institute of Hawaii

Ron P. Gallemore, MD. PhD

Role: PRINCIPAL_INVESTIGATOR

Retina Macula Institute

Brian B. Berger, MD

Role: PRINCIPAL_INVESTIGATOR

Retina Research Center

Homayoun Tabandeh, MD

Role: PRINCIPAL_INVESTIGATOR

Retina Vitreous Associates

Dennis M. Marcus, MD

Role: PRINCIPAL_INVESTIGATOR

Southeast Retina

Robert S. Wirthlin, MD

Role: PRINCIPAL_INVESTIGATOR

Spokane Eye Clinic

David Callanan, MD

Role: PRINCIPAL_INVESTIGATOR

Texas Retina Associates in Arlington

Karl G. Csaky, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Texas Retina Associates in Dallas

Surendar Purohit, MD

Role: PRINCIPAL_INVESTIGATOR

TLC Eye Care & Laser Center

Victor H. Gonzalez, MD

Role: PRINCIPAL_INVESTIGATOR

Valley Retina Institute

Louis Glazer, MD

Role: PRINCIPAL_INVESTIGATOR

Vitreo-Retinal Associates

Dean Eliott, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts Eye and Ear Infirmary, Harvard Medical School

Locations

Stanley M Truhlsen Eye Institute

Omaha, Nebraska, United States

Countries

United States

Other Identifiers

2010-007-03-DME

Identifier Type: -

Identifier Source: org_study_id