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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 acuity

Anatomic 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

Page last updated: August 23, 2015

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