The Ranibizumab for Edema of the mAcula in Diabetes-2 (READ-2) Study

NCT00407381 | Completed Phase 2 Results DMC

• 1 other identifier: NA_00005254
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 20

Brief Summary

This study is being done to see if the investigational drug Ranibizumab (RBZ) given by injection into the eye, is safe and effective to use in people with diabetic macular edema (DME). The investigators want to compare RBZ to laser treatment which is the current standard way to treat DME. RBZ blocks a growth factor that is thought to be involved in the formation of abnormal blood vessels that cause loss of vision in patients with DME.

Conditions

Diabetic Macular Edema

Keywords

DME

Outcome Measures

Primary Outcomes (1)

• Mean Change in Best Corrected Visual Acuity (BCVA) at Month 6

  Mean change of best corrected visual acuity letters (BCVA) at month 6

  6 months

Study Arms (3)

Ranibizumab

EXPERIMENTAL

Ranibizumab (RBZ) intravitreal injection alone

Drug: Ranibizumab

Laser

ACTIVE COMPARATOR

Laser photocoagulation

Procedure: Laser photocoagulation

Laser with Ranibizumab

EXPERIMENTAL

Laser following intravitreal injection of RBZ

Drug: Ranibizumab; Procedure: Laser photocoagulation

Interventions

Ranibizumab DRUG

Ranibizumab for intravitreal injection. .05ml dosing at 30 day intervals and pro re nata (PRN) with dosing criteria.

Also known as: Lucentis

Laser with Ranibizumab; Ranibizumab

Laser photocoagulation PROCEDURE

Laser photocoagulation in either focal or grid pattern as determined by investigator.

Laser; Laser with Ranibizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent and authorization of use and disclosure of protected health information
• Age greater than 18 years
• Diagnosis of diabetes mellitus (type 1 or type 2) and serum HbA1c greater than 5.5% within 12 months of randomization
• Retinal thickening secondary to diabetes mellitus (diabetic macular edema) involving the center of the fovea.
• Diagnosis must be confirmed by OCT images
• Foveal thickness of greater than 250, as assessed by OCT
• Best corrected visual acuity score in the study eye of 20/40 to 20/320 inclusive (Snellen equivalents using the ETDRS protocol at a distance of 4 meters). Only one eye will be treated in the study. If both eyes are eligible, the investigator will select the eye to be enrolled. Visual acuity in the non-study eye must be greater than 20/800.
• In the opinion of the investigator, decreased vision in the study eye is due to foveal thickening from DME and not from other obvious causes.
• In the opinion of the investigator, laser photocoagulation can be withheld for at least 30 days after the patient has enrolled in the study

You may not qualify if:

• Panretinal photocoagulation or macular photocoagulation within 3 months of study entry in the study eye
• Use of intraocular or periocular injection of steroids in the study eye (e.g., triamcinolone) within 3 months of study entry
• Previous participation in a study and receipt of anti-angiogenic drugs (pegaptanib sodium, ranibizumab, anecortave acetate, protein kinase C inhibitor, etc.) within 2 months of study entry
• Eyes in which the investigators do not feel appropriate to do any additional laser photocoagulation
• Proliferative diabetic retinopathy in the study eye, with the exceptions of inactive, fibrotic proliferative diabetic retinopathy that has regressed following pan-retinal laser photocoagulation or tufts of neovascularization elsewhere (NVE) less than one disc area with no vitreous hemorrhage
• Vitreomacular traction or epiretinal membrane in the study eye evident biomicroscopically or by OCT
• Structural damage to the center of the macula in the study eye likely to preclude improvement in visual acuity following the resolution of macular edema, including atrophy of the retinal pigment epithelium, subretinal fibrosis, laser scar(s), macular ischemia, or organized hard exudate plaque
• Ocular disorders in the study eye that may confound interpretation of study results, including retinal vascular occlusion, retinal detachment, macular hole, or choroidal neovascularization of any cause (e.g., age related macular degeneration (AMD), ocular histoplasmosis, or pathologic myopia)
• Concurrent disease in the study eye that could compromise visual acuity or require medical or surgical intervention during the first 6-month study period
• Eyes which are likely to need cataract surgery and intraocular lens implantation within the first 6 months of the study
• Cataract surgery in the study eye within 3 months of study entry; Yttrium-Aluminum-Garnet (YAG) laser capsulotomy within 2 months of study entry; or any other intraocular surgery within 3 months preceding Day 0.
• History of vitreoretinal surgery in the study eye within 3 months of study entry
• Uncontrolled glaucoma (defined as intraocular pressure greater than 30 mm Hg despite treatment with anti-glaucoma medications)
• Uncontrolled diabetes mellitus, as evidenced by glycosylated hemoglobin (HbA1c) value greater than 12%
• Premenopausal women not using adequate contraception

Sponsors & Collaborators

• Johns Hopkins University: lead
• Juvenile Diabetes Research Foundation: collaborator
• Genentech, Inc.: collaborator

Study Sites (20)

Retinal Consultants of Arizona

Phoenix, Arizona, 85014, United States

Location

Retina-Vitreous Associates Medical Group

Beverly Hills, California, 90211, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

East Bay Retina Consultants

Oakland, California, 94609, United States

Location

Retina Institute of California

Pasadena, California, 91105, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Yale Eye Center

New Haven, Connecticut, 06511, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Illinois Retina Associates Rush University

Chicago, Illinois, 60435, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Midwest Eye Institute

Indianapolis, Indiana, 46280, United States

Location

Wilmer Eye Institute at Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287, United States

Location

Ophthalmic Consultants of Boston

Boston, Massachusetts, 02114, United States

Location

New England Retina Consultants, PC

West Springfield, Massachusetts, 01089, United States

Location

Retinal Consultants of Nevada

Las Vegas, Nevada, 89109, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

Duke Eye Center

Durham, North Carolina, 27710, United States

Location

Eye Care Specialists, PC

Kingston, Pennsylvania, 18704, United States

Location

Southern New England Retina Associates

Providence, Rhode Island, 02903, United States

Location

Black Hills Regional Eye Institute

Rapid City, South Dakota, 57701, United States

Location

Related Publications (1)

• Do DV, Nguyen QD, Khwaja AA, Channa R, Sepah YJ, Sophie R, Hafiz G, Campochiaro PA; READ-2 Study Group. Ranibizumab for edema of the macula in diabetes study: 3-year outcomes and the need for prolonged frequent treatment. JAMA Ophthalmol. 2013 Feb;131(2):139-45. doi: 10.1001/2013.jamaophthalmol.91.

  PMID: 23544200 DERIVED

MeSH Terms

Interventions

Ranibizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Quan Dong Nguyen, MD, MSc
• Organization: University of Nebraska

quan.nguyen@unmc.edu

4025591855

Study Officials

• Diana Do, MD

  Truhlsen Eye Institute, University of Nebraska Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2006
• First Posted: December 5, 2006
• Study Start: December 1, 2006
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2011
• Last Updated: March 31, 2017
• Results First Posted: March 31, 2017

Record last verified: 2017-03

Locations

US (20)