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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Johns Hopkins University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Juvenile Diabetes Research Foundation
Genentech
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00407381
First received: December 1, 2006
Last updated: January 30, 2009
Last verified: January 2009
  Purpose

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.


Condition Intervention Phase
Diabetic Macular Edema
Drug: Ranibizumab
Procedure: Laser photocoagulation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ranibizumab for Edema of the Macula in Diabetes: a Phase 2 Study ( The Read-2 Study)

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Improvement in vision of 15 or more letters, or achieve a final vision of 50 letters (20/25) or better if baseline VA was 40 letters (20/40) [ Time Frame: 6 mos, 12 mos and 24 mos. Study Extended to 36 mos. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Several outcomes related to OCT measurements and fluorescein angiography. [ Time Frame: 6 mos, 12 mos and 24 mos, study extended to 36 mos. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 126
Study Start Date: December 2006
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RBZ
RBZ intravitreal injection alone
Drug: Ranibizumab
Ranibizumab for intravitreal injection. .05ml dosing at 30 day intervals and PRN with dosing criteria.
Active Comparator: Laser
Laser photocoagulation
Procedure: Laser photocoagulation
Laser photocoagulation in either focal or grid pattern as determined by investigator.
Experimental: Laser with RBZ
Laser following intravitreal injection of RBZ
Drug: Ranibizumab
Ranibizumab for intravitreal injection. .05ml dosing at 30 day intervals and PRN with dosing criteria.
Procedure: Laser photocoagulation
Laser photocoagulation in either focal or grid pattern as determined by investigator.

Detailed Description:

The READ-2 Study is a phase 2 randomized, multi-center clinical trial to be conducted under an investigator-initiated IND. The study aims to enroll 126 patients, who will be randomized into 3 different groups. The primary objectives of the READ-2 Study are: (a) to obtain data on the bioactivity and dose interval effects of intravitreal ranibizumab (RBZ) alone, as well as in combination with laser photocoagulation, on retinal thickness and visual acuity in subjects with DME; and (b) to obtain additional safety and bioactivity data to aid in the design of a phase 3 clinical trial to evaluate ranibizumab as a therapeutic option for patients with DME The study consists of a 2-week screening period (Days -14 to 0), a 6-month treatment period with a primary time endpoint, and a 18-month follow-up and treatment period with secondary time endpoints. Consented subjects will enter the 14-day screening period to determine eligibility. Serum chemistry and hematology testing, urinalysis, pregnancy testing, and macular thickness measurements based on optical coherence tomography (OCT) will be performed. Screening will also include VA, ophthalmic examination and FA entry criteria.

Patients who have ETDRS visual acuity of 20/40 or worse, but better than or equal to 20/320 due to foveal thickening from macular edema secondary to diabetes (type 1 or 2) and who meet eligibility criteria will be eligible to enroll in the study. Baseline foveal thickness by OCT must be at least 250, which is often associated with VA of 20/40 or worse and which provides sufficient thickening so that a treatment effect is easily detectable (Nguyen et al. 2004). Approximately 126 patients with DME will be enrolled in this study from all clinical sites in the study. Every effort will be made to recruit and enroll eligible patients from men and women of all ethnic and social backgrounds. Patients who meet entry criteria will be able to enroll in the study until the quota of patients has been achieved.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion:

  • 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 greter 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

Exclusion Criteria:

  • 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 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., 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
  • Any women who are pregnant
  • INR greater than or equal to 3.0 (e.g. due to current treatment with warfarin). The use of aspirin or other anticoagulants is not an exclusion
  • History of gastrointestinal bleeding within 2 months of study enrollment
  • History of major gastrointestinal, cardiothoracic, gynecological, genitourinary, or orthopedic surgeries within 2 months of study enrollment
  • History of cerebral vascular accident, myocardial infarction, transient ischemic attacks within 6 months of study enrollment
  • Any patients who are on renal dialysis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00407381

Locations
United States, Arizona
Retinal Consultants of Arizona
Phoenix, Arizona, United States, 85014
United States, California
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States, 90211
University of Southern California
Los Angeles, California, United States, 90033
East Bay Retina Consultants
Oakland, California, United States, 94609
Retina Institute of California
Pasadena, California, United States, 91105
University of California, San Francisco
San Francisco, California, United States, 94143
United States, Connecticut
Yale Eye Center
New Haven, Connecticut, United States, 06511
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Illinois Retina Associates Rush University
Chicago, Illinois, United States, 60435
United States, Indiana
Midwest Eye Institute
Indianapolis, Indiana, United States, 46280
United States, Maryland
Wilmer Eye Institute at Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States, 02114
New England Retina Consultants, PC
West Springfield, Massachusetts, United States, 01089
United States, Nevada
Retinal Consultants of Nevada
Las Vegas, Nevada, United States, 89109
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131
United States, North Carolina
Duke Eye Center
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Eye Care Specialists, PC
Kingston, Pennsylvania, United States, 18704
United States, Rhode Island
Southern New England Retina Associates
Providence, Rhode Island, United States, 02903
United States, South Dakota
Black Hills Regional Eye Institute
Rapid City, South Dakota, United States, 57701
Sponsors and Collaborators
Johns Hopkins University
Juvenile Diabetes Research Foundation
Genentech
Investigators
Principal Investigator: Diana Do, MD Johns Hopkins Universtiy
  More Information

No publications provided by Johns Hopkins University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Quan Dong Nguyen, MD, MSc, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00407381     History of Changes
Other Study ID Numbers: NA_00005254
Study First Received: December 1, 2006
Last Updated: January 30, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Johns Hopkins University:
DME

Additional relevant MeSH terms:
Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on September 16, 2014