Ranibizumab for Edema of the Macula in Diabetes: Protocol 3 With High Dose - the READ 3 Study
Information source: Johns Hopkins University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetic Macular Edema
Intervention: Ranibizumab (Drug); ranibizumab (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Johns Hopkins University Official(s) and/or principal investigator(s): Diana V Do, MD, Principal Investigator, Affiliation: Johns Hopkins University
Overall contact: Jennifer Denton, Phone: 410-502-7621, Email: jdenton2@jhmi.edu
Summary
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).
Clinical Details
Official title: Ranibizumab for Edema of the Macula in Diabetes: Protocol 3 With High Dose - the READ 3 Study
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Primary outcome: Adverse events
Secondary outcome: Visual acuityAnatomic Retinal changes
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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 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
- 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
- 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
Locations and Contacts
Jennifer Denton, Phone: 410-502-7621, Email: jdenton2@jhmi.edu
Retina Vitreous Associates, Beverly Hills, California 90211, United States; Not yet recruiting David Boyer, MD, Phone: 310-289-2478, Email: vitdoc@aol.com David Boyer, MD, Principal Investigator
University of California San Diego, LaJolla, California 92037, United States; Not yet recruiting Kang Zhang, MD, Phone: 858-246-0814, Email: k5zhang@ad.ucsd.edu Kang Zhang, MD, Principal Investigator
Doheny Eye Institute, Los Angeles, California 90033, United States; Not yet recruiting Dean Eliot, MD, Phone: 323-442-6582, Email: DEliot@doheny.org Dean Eliot, MD, Principal Investigator
East Bay Retina Institute, Oakland, California 94609, United States; Not yet recruiting Eugene Lit, MD, Phone: 510-444-1600, Email: esl@post.harvard.edu Eugene Lit, MD, Principal Investigator
Retina Macula Institute, Torrance, California 90503, United States; Not yet recruiting Ron Gallemore, MD, Phone: 310-944-9393, Email: retina2000@yahoo.com Ron Gallemore, MD, Principal Investigator
Retina Group of Florida, Fort Lauderdale, Florida 33334, United States; Not yet recruiting Larry Halperin, MD, Phone: 561-504-3666, Email: lhalperin@mac.com Larry Halperin, MD, Principal Investigator
Retina Institute of Hawaii, Honolulu, Hawaii 96815, United States; Not yet recruiting Michael Bennett, MD, Phone: 808-955-0255, Email: deb@retinahawaii.com Michael Bennett, MD, Principal Investigator
Illinois Retina Associates, Joliet, Illinois 60435, United States; Not yet recruiting John Pollack, MD John Pollack, MD, Principal Investigator
University of Kansas, Prairie Village, Kansas 66208, United States; Not yet recruiting Andrew Symons, MD, PhD, Phone: 913-588-6605, Email: asymons@kumc.edu Andrew Symons, MD, PhD, Principal Investigator
Johns Hopkins University Wilmer Eye Institute, Baltimore, Maryland 21287, United States; Recruiting Jennifer Denton, Phone: 410-502-7621, Email: jdenton2@jhmi.edu Diana V Do, MD, Principal Investigator Quan D Nguyen, MD, MSc, Sub-Investigator Peter A Campochiaro, MD, Sub-Investigator
Eye Care Specialists, Kingston, Pennsylvania 18704, United States; Not yet recruiting Erik Kruger, MD, Phone: 570-288-7405, Email: efkrug@yahoo.com Erik Kruger, MD, Principal Investigator
Black Hills Eye Institute, Rapid City, South Dakota 57701, United States; Not yet recruiting Prema Abraham, MD, Phone: 605-341-9190, Email: retina@bhrei.com Prema Abraham, MD, Principal Investigator
Texas Retina Associates, Arlington, Texas 76012, United States; Not yet recruiting David Callanan, MD, Phone: 817-261-9625, Email: dcallanan@texasretina.com David Callanan, MD, Principal Investigator
Additional Information
Starting date: February 2010
Last updated: March 29, 2010
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