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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01077401
Recruitment Status : Completed
First Posted : March 1, 2010
Results First Posted : April 28, 2017
Last Update Posted : April 28, 2017
Sponsor:
Collaborator:
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE February 26, 2010
First Posted Date  ICMJE March 1, 2010
Results First Submitted Date  ICMJE August 30, 2016
Results First Posted Date  ICMJE April 28, 2017
Last Update Posted Date April 28, 2017
Study Start Date  ICMJE February 2010
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2017)
Deaths Due to Myocardial Infarction [ Time Frame: 6 Months ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 26, 2010)
Adverse events [ Time Frame: 3,6, 9 and 12 months ]
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2017)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 26, 2010)
  • Visual acuity [ Time Frame: 3, 6 9 and 12 months ]
    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 ]
    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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ranibizumab for Edema of the Macula in Diabetes: Protocol 3 With High Dose - the READ 3 Study
Official Title  ICMJE Ranibizumab for Edema of the Macula in Diabetes: Protocol 3 With High Dose - the READ 3 Study
Brief 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Diabetic Macular Edema
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Ranibizumab
  • 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.
    Intervention: Drug: ranibizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 20, 2017)
152
Original Estimated Enrollment  ICMJE
 (submitted: February 26, 2010)
92
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01077401
Other Study ID Numbers  ICMJE NA_00034586
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Johns Hopkins University
Original Responsible Party Dr. Diana V. Do, Johns Hopkins University
Current Study Sponsor  ICMJE Johns Hopkins University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Juvenile Diabetes Research Foundation
Investigators  ICMJE
Principal Investigator: Diana V Do, MD Truhlsen Eye Institute, University of Nebraska Medical Center
PRS Account Johns Hopkins University
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP