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Ranibizumab for Edema of the Macula in Diabetes: Protocol 3 With High Dose - the READ 3 Study (READ 3)

This study has been completed.
Sponsor:
Collaborator:
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01077401
First received: February 26, 2010
Last updated: March 20, 2017
Last verified: March 2017
  Purpose
The purpose of this study is to investigate the safety, tolerability, bioactivity, and dose response of two different dosages (0.5 mg and 2.0 mg) of ranibizumab (RBZ) in patients with diabetic macular edema (DME).

Condition Intervention Phase
Diabetic Macular Edema Drug: Ranibizumab Drug: ranibizumab Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant
Primary Purpose: Treatment
Official Title: Ranibizumab for Edema of the Macula in Diabetes: Protocol 3 With High Dose - the READ 3 Study

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Deaths Due to Myocardial Infarction [ Time Frame: 6 Months ]

Secondary Outcome Measures:
  • Mean Change in Best Corrected Visual Acuity From Baseline to Month 6 [ Time Frame: baseline 6 Months ]
    Mean change in best corrected visual acuity (BCVA) (ETDRS) at 4 meters in the study eye over time through month 6.

  • Mean Change in Retinal Thickness at Month 6 [ Time Frame: baseline to6 Months ]

Enrollment: 152
Study Start Date: February 2010
Study Completion Date: March 2013
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ranibizumab 0.5mg
Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria.
Drug: Ranibizumab
Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria.
Other Name: lucentis
Experimental: Ranibizumab 2.0 mg
Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria.
Drug: ranibizumab
Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria.
Other Name: lucentis high-dose

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Signed informed consent and authorization of use and disclosure of protected health information

  • Age ≥18 years
  • Diagnosis of diabetes mellitus (type 1 or type 2)
  • Serum HbA1c ≥ 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 fluorescein angiography and OCT images
  • Foveal thickness of ≥ 250 μm,
  • 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). The non-study eye must be ≥ 20 letters (approximate Snellen equivalent 20/400).
  • 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 of decreased vision If a female of childbearing potential, a negative pregnancy test and commitment to the use of at least two forms of effective contraception (birth control) for the duration of the study are necessary.

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, bevacizumab, anecortave acetate, protein kinase C inhibitor, etc.) within 2 months of study entry
  • Proliferative diabetic retinopathy in the study eye, with the exceptions of
  • Inactive, fibrotic proliferative diabetic retinopathy that has regressed following panretinal 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 optical coherence tomography (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
  • Cataract surgery in the study eye within 3 months of study entry; Yttrium-Aluminum- Garnet (YAG) laser capsulotomy within 1 month 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 ≥30 mm Hg despite treatment with anti-glaucoma medications)
  • Blood pressure exceeding 180/100 (sitting) during the screening period
  • Uncontrolled diabetes mellitus, as evidenced by glycosylated hemoglobin (HbA1c) value >13%
  • Renal failure requiring dialysis or renal transplant
  • Premenopausal women unwilling to commit to adequate contraception
  • History of other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use an investigational drug, might affect interpretation of the results of the study, or render the subject at high risk from treatment complications
  • International normalized ratio (INR) ≥ 3.0 (e.g. due to current treatment with warfarin). The use of aspirin or other anticoagulants is not an exclusion
  • History of cerebral vascular accident, myocardial infarction, transient ischemic attacks within 3 months of study enrollment.
  • Have a history of hypersensitivity to ranibizumab or any of its components
  • Have the presence of active malignancy, including lymphoproliferative disorders. Subjects with a history of fully resolved basal or squamous cell skin cancer may be enrolled.

Other

  • Inability to comply with study or follow-up procedures
  • Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated.
  • Participation in another simultaneous medical investigation or trial
  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: NCT01077401

Locations
United States, California
Retina Vitreous Associates
Beverly Hills, California, United States, 90211
University of California San Diego
LaJolla, California, United States, 92037
Doheny Eye Institute
Los Angeles, California, United States, 90033
East Bay Retina Institute
Oakland, California, United States, 94609
Retina Macula Institute
Torrance, California, United States, 90503
United States, Florida
Retina Group of Florida
Fort Lauderdale, Florida, United States, 33334
United States, Hawaii
Retina Institute of Hawaii
Honolulu, Hawaii, United States, 96815
United States, Illinois
Illinois Retina Associates
Joliet, Illinois, United States, 60435
United States, Kansas
University of Kansas
Prairie Village, Kansas, United States, 66208
United States, Maryland
Johns Hopkins University Wilmer Eye Institute
Baltimore, Maryland, United States, 21287
United States, Pennsylvania
Eye Care Specialists
Kingston, Pennsylvania, United States, 18704
United States, South Dakota
Black Hills Eye Institute
Rapid City, South Dakota, United States, 57701
United States, Texas
Texas Retina Associates
Arlington, Texas, United States, 76012
Sponsors and Collaborators
Johns Hopkins University
Juvenile Diabetes Research Foundation
Investigators
Principal Investigator: Diana V Do, MD Truhlsen Eye Institute, University of Nebraska Medical Center
  More Information

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01077401     History of Changes
Other Study ID Numbers: NA_00034586
Study First Received: February 26, 2010
Results First Received: August 30, 2016
Last Updated: March 20, 2017

Keywords provided by Johns Hopkins University:
Diabetic
edema
DME

Additional relevant MeSH terms:
Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Ranibizumab
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on June 23, 2017