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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Johns Hopkins University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Juvenile Diabetes Research Foundation
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01077401
First received: February 26, 2010
Last updated: March 29, 2010
Last verified: February 2010
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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:
  • Adverse events [ Time Frame: 3,6, 9 and 12 months ] [ Designated as safety issue: Yes ]

    The primary outcome measures for safety and tolerability are the following:

    The incidence and severity of systemic and ocular adverse events that are associated with repeated intravitreal injections of two doses of RBZ in subjects with DME such as cardiovascular events, intraocular reactions (inflammation), vitreous hemorrhage, retinal detachment, endophthalmitis (intraocular infection),increased intraocular pressure, and cataract formation, among others.



Secondary Outcome Measures:
  • Visual acuity [ Time Frame: 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]
    Mean change in BCVA (ETDRS) at 4 meters in the study eye over time through month 12.

  • Anatomic Retinal changes [ Time Frame: 3, 6, 9 and 12 months ] [ Designated as safety issue: Yes ]

    Anatomic retinal changes in the study eye as assessed by color fundus photography,fluorescein angiography, and OCT, from Baseline to Month 6 and Month 12, including:

    • Extent of fluorescein leakage from CSME
    • Progression to proliferative diabetic retinopathy by ETDRS grade
    • Change in central retinal thickness, as assessed by OCT
    • Change in central retinal volume, as assessed by OCT.


Estimated Enrollment: 92
Study Start Date: February 2010
Estimated Study Completion Date: March 2013
Estimated 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
Genders Eligible for Study:   Both
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 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
  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

Contacts
Contact: Jennifer Denton 410-502-7621 jdenton2@jhmi.edu

Locations
United States, California
Retina Vitreous Associates Not yet recruiting
Beverly Hills, California, United States, 90211
Contact: David Boyer, MD    310-289-2478    vitdoc@aol.com   
Principal Investigator: David Boyer, MD         
University of California San Diego Not yet recruiting
LaJolla, California, United States, 92037
Contact: Kang Zhang, MD    858-246-0814    k5zhang@ad.ucsd.edu   
Principal Investigator: Kang Zhang, MD         
Doheny Eye Institute Not yet recruiting
Los Angeles, California, United States, 90033
Contact: Dean Eliot, MD    323-442-6582    DEliot@doheny.org   
Principal Investigator: Dean Eliot, MD         
East Bay Retina Institute Not yet recruiting
Oakland, California, United States, 94609
Contact: Eugene Lit, MD    510-444-1600    esl@post.harvard.edu   
Principal Investigator: Eugene Lit, MD         
Retina Macula Institute Not yet recruiting
Torrance, California, United States, 90503
Contact: Ron Gallemore, MD    310-944-9393    retina2000@yahoo.com   
Principal Investigator: Ron Gallemore, MD         
United States, Florida
Retina Group of Florida Not yet recruiting
Fort Lauderdale, Florida, United States, 33334
Contact: Larry Halperin, MD    561-504-3666    lhalperin@mac.com   
Principal Investigator: Larry Halperin, MD         
United States, Hawaii
Retina Institute of Hawaii Not yet recruiting
Honolulu, Hawaii, United States, 96815
Contact: Michael Bennett, MD    808-955-0255    deb@retinahawaii.com   
Principal Investigator: Michael Bennett, MD         
United States, Illinois
Illinois Retina Associates Not yet recruiting
Joliet, Illinois, United States, 60435
Contact: John Pollack, MD         
Principal Investigator: John Pollack, MD         
United States, Kansas
University of Kansas Not yet recruiting
Prairie Village, Kansas, United States, 66208
Contact: Andrew Symons, MD, PhD    913-588-6605    asymons@kumc.edu   
Principal Investigator: Andrew Symons, MD, PhD         
United States, Maryland
Johns Hopkins University Wilmer Eye Institute Recruiting
Baltimore, Maryland, United States, 21287
Contact: Jennifer Denton    410-502-7621    jdenton2@jhmi.edu   
Principal Investigator: Diana V Do, MD         
Sub-Investigator: Quan D Nguyen, MD, MSc         
Sub-Investigator: Peter A Campochiaro, MD         
United States, Pennsylvania
Eye Care Specialists Not yet recruiting
Kingston, Pennsylvania, United States, 18704
Contact: Erik Kruger, MD    570-288-7405    efkrug@yahoo.com   
Principal Investigator: Erik Kruger, MD         
United States, South Dakota
Black Hills Eye Institute Not yet recruiting
Rapid City, South Dakota, United States, 57701
Contact: Prema Abraham, MD    605-341-9190    retina@bhrei.com   
Principal Investigator: Prema Abraham, MD         
United States, Texas
Texas Retina Associates Not yet recruiting
Arlington, Texas, United States, 76012
Contact: David Callanan, MD    817-261-9625    dcallanan@texasretina.com   
Principal Investigator: David Callanan, MD         
Sponsors and Collaborators
Johns Hopkins University
Juvenile Diabetes Research Foundation
Investigators
Principal Investigator: Diana V Do, MD Johns Hopkins University
  More Information

No publications provided

Responsible Party: Dr. Diana V. Do, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01077401     History of Changes
Other Study ID Numbers: NA_00034586
Study First Received: February 26, 2010
Last Updated: March 29, 2010
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 19, 2014