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)

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

Interventions

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

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

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

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

Sponsors & Collaborators

• Juvenile Diabetes Research Foundation

  collaborator OTHER

• iCo Therapeutics Inc.

  collaborator INDUSTRY

• Johns Hopkins University

  lead OTHER

Principal Investigators

• Diana V. Do, MD · Stanley M Truhlsen Eye Institute, University of Nebraska Medical Center

• Robert Wong, MD · Austin Retina Associates

• Michael J. Tolentino, MD · Center for Retina Macula Disease

• Prema Abraham, MD · Black Hills Regional Eye Institute

• Eugene Lit, MD · East Bay Retina Institute

• Michael J. Elman, MD · Elman Retina Group

• Thomas A. Barnard, MD · Florida Retina Institute

• Thomas A. Ciulla, MD · Midwest Eye Institute

• Richard B. Rosen, MD · New York Eye and Ear Infirmary

• Henry L. Hudson, MD · Retina Centers, P.C.

• Pravin Dugel, MD · Retina Consultants of Arizona

• Gregg T. Kokame, MD · Retina Consultants of Hawaii, Pali Momi Medical Center

• David M. Brown, MD · Retina Consultants Houston

• Larry S. Halperin, MD · Retina Group of Florida

• Goergios Papastergio, MD · Retina Institute of Hawaii

• Ron P. Gallemore, MD. PhD · Retina Macula Institute

• Brian B. Berger, MD · Retina Research Center

• Homayoun Tabandeh, MD · Retina Vitreous Associates

• Dennis M. Marcus, MD · Southeast Retina

• Robert S. Wirthlin, MD · Spokane Eye Clinic

• David Callanan, MD · Texas Retina Associates in Arlington

• Karl G. Csaky, MD, PhD · Texas Retina Associates in Dallas

• Surendar Purohit, MD · TLC Eye Care & Laser Center

• Victor H. Gonzalez, MD · Valley Retina Institute

• Louis Glazer, MD · Vitreo-Retinal Associates

• Dean Eliott, MD · Massachusetts Eye and Ear Infirmary, Harvard Medical School

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-02-29

Primary Completion

2014-02-28

Completion

2014-10-31

Countries

• United States

Study Locations