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Trial record 29 of 32 for:    retina associates of kentucky

Prompt Panretinal Photocoagulation Versus Ranibizumab+Deferred Panretinal Photocoagulation for Proliferative Diabetic Retinopathy (Protocol S)

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ClinicalTrials.gov Identifier: NCT01489189
Recruitment Status : Completed
First Posted : December 9, 2011
Results First Posted : June 1, 2016
Last Update Posted : July 10, 2018
Sponsor:
Collaborators:
National Eye Institute (NEI)
Genentech, Inc.
Information provided by (Responsible Party):
Jaeb Center for Health Research

Tracking Information
First Submitted Date  ICMJE December 6, 2011
First Posted Date  ICMJE December 9, 2011
Results First Submitted Date  ICMJE February 12, 2016
Results First Posted Date  ICMJE June 1, 2016
Last Update Posted Date July 10, 2018
Study Start Date  ICMJE March 2012
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 25, 2016)
Mean Change in Visual Acuity From Baseline [ Time Frame: 2-years ]
Visual acuity is measured as a continuous integer letter score from 0 to 100, with higher numbers indicating better visual acuity. A letter score of 85 is approximately 20/20 and a letter score of 70 is approximately 20/40, the legal unrestricted driving limit in most states. A 5-letter change for an individual is approximately equal to a 1-line change on a vision chart.
Original Primary Outcome Measures  ICMJE
 (submitted: December 7, 2011)
Mean change in visual acuity from baseline to 2 years [ Time Frame: 2-years ]
Change History Complete list of historical versions of study NCT01489189 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 8, 2016)
  • Mean Visual Acuity [ Time Frame: 2-years ]
    Visual acuity is measured as a continuous integer letter score from 0 to 100, with higher numbers indicating better visual acuity. A letter score of 85 is approximately 20/20 and a letter score of 70 is approximately 20/40, the legal unrestricted driving limit in most states. A 5-letter change for an individual is approximately equal to a 1-line change on a vision chart.
  • Number of Eyes With Greater Than or Equal to 10 Letter Vision Gain [ Time Frame: 2-years ]
  • Humphrey Visual Field Test Cumulative Score Change From Baseline [ Time Frame: 2-years ]
    Visual fields, collected using the Humphrey Visual Field analyzer, measured the total point score (sum of retinal sensitivities of all points) tested on 30-2 and 60-4 patterns, which included the mid-peripheral and peripheral visual fields. A lower score indicates greater visual field loss.The cumulative score is the sum of all visual field sensitivity values for each of the four individual quadrants of the visual field (the quadrants are divided by the horizontal and vertical lines). The range can be from 0 to about 600 for the 30-2 test [for each quadrant], and from 0 to about 400 or 450 for the peripheral test.
  • Frequency of Vitrectomy [ Time Frame: 2-years ]
  • Mean Change in OCT Central Subfield Thickness From Baseline [ Time Frame: 2-years ]
    All baseline and 2-year optical coherence tomography (OCT) scans were evaluated by the OCT reading center.
  • Development of Central DME With Vision Impairment by 2-years [ Time Frame: 2-years ]
  • Number of Eyes With Vitreous Hemorrhage [ Time Frame: 2-years ]
  • Number of Eyes Without Active or Regressed Neovascularization on Fundus Photography at 2-years [ Time Frame: 2-years ]
  • Number of Eyes With Greater Than or Equal to 10 Letter Vision Loss [ Time Frame: 2-year ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 7, 2011)
  • Mean visual acuity [ Time Frame: 2-years ]
  • Proportion of eyes with 10 and 15 letter vision loss or gain [ Time Frame: 2-years ]
  • Humphrey visual field (HVF) testing, at sites with HVF capabilities NEI VFQ-25, and UAB-LLQ [ Time Frame: 2-years ]
    VFQ-25=Visual Function Questionnaire-25, UAB-JJQ=University of Alabama at Birmingham Low Luminance Questionnaire,
  • Need for Vitrectomy [ Time Frame: 2-years ]
  • Mean Change in OCT Central Subfield Thickness From Baseline [ Time Frame: 2-years ]
  • Proportion of eyes with progression to central subfield involved diabetic macular edema [ Time Frame: 2-year ]
    In eyes without central subfield involved diabetic macular edema only.
  • Percent of eyes with vitreous hemorrhage [ Time Frame: 2-years ]
  • Proportion of eyes with complete regression of neovascularization on fundus photography from baseline to 2-years [ Time Frame: baseline to 2-years ]
  • Treatment and Follow-up Costs [ Time Frame: 2-years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prompt Panretinal Photocoagulation Versus Ranibizumab+Deferred Panretinal Photocoagulation for Proliferative Diabetic Retinopathy
Official Title  ICMJE Prompt Panretinal Photocoagulation Versus Intravitreal Ranibizumab With Deferred Panretinal Photocoagulation for Proliferative Diabetic Retinopathy
Brief Summary

The primary objective of the protocol is to determine if visual acuity outcomes at 2 years in eyes with proliferative diabetic retinopathy (PDR) that receive anti-vascular endothelial growth factor (anti-VEGF) therapy with deferred panretinal photocoagulation (PRP) are non-inferior to those in eyes that receive standard prompt PRP therapy.

Secondary objectives include:

  • Comparing other visual function outcomes (including Humphrey visual field testing and study participant self-reports of visual function) in eyes receiving anti-VEGF with deferred PRP with those in eyes receiving prompt PRP.
  • Determining percent of eyes not requiring PRP when anti-VEGF is given in the absence of prompt PRP.
  • Comparing safety outcomes between treatment groups.
  • Comparing associated treatment and follow-up exam costs between treatment groups.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Proliferative Diabetic Retinopathy
Intervention  ICMJE
  • Other: Prompt Panretinal Photocoagulation
    Panretinal photocoagulation alone at baseline (full session completed within 56 days).
  • Drug: 0.5-mg Ranibizumab
    Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
  • Other: Deferred panretinal photocoagulation
    PRP is deferred until failure/futility criteria for intravitreal injection are met.
Study Arms  ICMJE
  • Experimental: Anti-VEGF+Deferred PRP
    Anti-VEGF= Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated.
    Interventions:
    • Drug: 0.5-mg Ranibizumab
    • Other: Deferred panretinal photocoagulation
  • Active Comparator: Prompt PRP
    PRP= Panretinal Photocoagulation. PRP alone.
    Intervention: Other: Prompt Panretinal Photocoagulation
Publications *

*   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: April 25, 2016)
305
Original Estimated Enrollment  ICMJE
 (submitted: December 7, 2011)
316
Actual Study Completion Date  ICMJE February 5, 2018
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Age >= 18 years -Individuals < 18 years old are not being included because proliferative diabetic retinopathy (PDR) is so rare in this age group that the diagnosis of PDR may be questionable.

Diagnosis of diabetes mellitus (type 1 or type 2)

Any one of the following will be considered to be sufficient evidence that diabetes is present:

  • Current regular use of insulin for the treatment of diabetes
  • Current regular use of oral anti-hyperglycemia agents for the treatment of diabetes
  • Documented diabetes by American Diabetes Association (ADA) and/or World Health Organization (WHO) criteria (see Procedures Manual for definitions) Able and willing to provide informed consent.

Meets at least all of the following ocular criteria criteria:

  • Presence of PDR which the investigator intends to manage with PRP alone but for which PRP can be deferred for at least 4 weeks in the setting of intravitreal ranibizumab, in the investigator's judgment.
  • Best corrected Electronic-Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity letter score > 24 (approximate Snellen equivalent 20/320) on the day of randomization.
  • Media clarity, pupillary dilation, and study participant cooperation sufficient to administer PRP and obtain adequate fundus photographs and optical coherence tomography (OCT).

    • Investigator must verify accuracy of OCT scan by ensuring it is centered and of adequate quality

Exclusion Criteria:

Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.

A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure, cardiovascular disease, and glycemic control).

  • Individuals in poor glycemic control who, within the last 4 months, initiated intensive insulin treatment (a pump or multiple daily injections) or plan to do so in the next 4 months should not be enrolled.

Participation in an investigational trial within 30 days of randomization that involved treatment with any drug that has not received regulatory approval for the indication being studied.

  • Study participants cannot receive another investigational drug while participating in the study.

Known allergy to any component of the study drug.

Blood pressure > 180/110 (systolic above 180 or diastolic above 110).

  • If blood pressure is brought below 180/110 by anti-hypertensive treatment, individual can become eligible.

Myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization.

Systemic anti-VEGF or pro-VEGF treatment within 4 months prior to randomization.

  • These drugs should not be used during the study.

For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 3 years.

  • Women who are potential study participants should be questioned about the potential for pregnancy. Investigator judgment is used to determine when a pregnancy test is needed.

Individual is expecting to move out of the area of the clinical center to an area not covered by another Diabetic Retinopathy Clinical Research Network (DRCR.net) certified clinical center during the 3 years of the study.

Individual has any of the following ocular characteristics:

  • History of prior panretinal photocoagulation (prior PRP is defined as ≥ 100 burns outside of the posterior pole)
  • Tractional retinal detachment involving the macula.

    -- A tractional retinal detachment is not an exclusion if it is outside of the posterior pole (not threatening the macula) and in the investigator's judgment, is not a contraindication to intravitreal ranibizumab treatment and also does not preclude deferring PRP for at least 4 weeks in the setting of intravitreal ranibizumab

  • Exam evidence of neovascularization of the angle (neovascularization of the iris alone is not an exclusion if it does not preclude deferring PRP for at least 4 weeks in the investigator's judgment).
  • If macular edema is present, it is considered to be primarily due to a cause other than diabetic macular edema.

    -- An eye should not be considered eligible if:

    • macular edema is present that is considered to be related to ocular surgery such as cataract extraction or
    • clinical exam and/or OCT suggest that vitreoretinal interface abnormalities disease (e.g., a taut posterior hyaloid or epiretinal membrane) is the primary cause of any macular edema.
  • An ocular condition is present (other than diabetic retinopathy) that, in the opinion of the investigator, might alter visual acuity during the course of the study (e.g., retinal vein or artery occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, etc.).

    -- A vitreous or preretinal hemorrhage is not an exclusion if it is out of the visual axis and in the investigator's judgment is not having any affect on visual acuity.

  • Substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by 3 lines or more (i.e., cataract would be reducing acuity to 20/40 or worse if eye were otherwise normal).
  • History of intravitreal anti-VEGF treatment at any time in the past 2 months.
  • History of corticosteroid treatment (intravitreal or peribulbar) at any time in the past 4 months.

    --If the investigator believes that there may still be a substantial effect 4 months after prior treatment (e.g., dose of intravitreal triamcinolone higher than 4 mg), the eye should not be included.

  • History of major ocular surgery (including vitrectomy, cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior 4 months or anticipated within the next 6 months following randomization.
  • History of (yttrium-aluminum-garnet) YAG capsulotomy performed within 2 months prior to randomization.
  • Aphakia.
  • Uncontrolled glaucoma (in investigator's judgment).
  • Exam evidence of severe external ocular infection, including conjunctivitis, chalazion, or substantial blepharitis
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 NCT01489189
Other Study ID Numbers  ICMJE DRCR.net Protocol S
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jaeb Center for Health Research
Study Sponsor  ICMJE Jaeb Center for Health Research
Collaborators  ICMJE
  • National Eye Institute (NEI)
  • Genentech, Inc.
Investigators  ICMJE
Study Chair: Jeffrey G Gross, MD Carolina Retina Center
PRS Account Jaeb Center for Health Research
Verification Date June 2018

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