Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ranibizumab DosE Comparison and the Role of LAser in REtinal Vein Occlusions (RELATE)

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: NCT01003106
Recruitment Status : Completed
First Posted : October 28, 2009
Results First Posted : March 15, 2016
Last Update Posted : March 15, 2016
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Peter A Campochiaro, MD, Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE October 26, 2009
First Posted Date  ICMJE October 28, 2009
Results First Submitted Date  ICMJE August 25, 2015
Results First Posted Date  ICMJE March 15, 2016
Last Update Posted Date March 15, 2016
Study Start Date  ICMJE November 2009
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 16, 2016)
Incidence and Severity of Ocular and Non-ocular Adverse Events. [ Time Frame: 36 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 27, 2009)
Incidence and Severity of Ocular and Non-ocular Adverse Events. [ Time Frame: 48 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 16, 2016)
  • Mean Change From Baseline to Month 6 in Best Corrected Visual Acuity in Patients Treated With 0.5mg Versus 2.0mg of Ranibizumab [ Time Frame: Baseline to month 6 ]
  • Mean Change From Month 6 to Month 36 in Best Corrected Visual Acuity in Patients Treated With Prn Ranibizumab+Laser Photocoagulation Versus Prn Ranibizumab Alone. [ Time Frame: Month 6- Month 36 ]
  • Mean Change From Baseline to Month 6 in Central Subfield Thickness in Patients Treated With 0.5mg Versus 2.0mg of Ranibizumab [ Time Frame: Baseline to month 6 ]
  • Mean Change From Month 6 to Month 36 in Central Subfield Thickness in Patients Treated With Prn Ranibizumab+Laser Photocoagulation Versus Prn Ranibizumab Alone. [ Time Frame: Month 6- Month 36 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 27, 2009)
  • Correlation of aqueous levels of ranibizumab throughout the study with mean change from baseline in BCVA [ Time Frame: 24 and 48 weeks ]
  • The mean change from baseline in BCVA in patients treated with 0.5mg ranibizumab versus those treated with 2.0mg ranibizumab. [ Time Frame: at Weeks 24 and 48 ]
  • mean change from baseline in excess foveal thickness (EFT) measured by optical coherence tomography (OCT) in patients treated with 0.5 versus 2.0 mg of ranibizumab. [ Time Frame: at Weeks 24 and 48 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ranibizumab DosE Comparison and the Role of LAser in REtinal Vein Occlusions
Official Title  ICMJE RanibizumabDosE Comparison (0.5mg and 2.0mg) and the Role of LAser in the ManagemenT of REtinal Vein Occlusion - A Pharmacodynamic Approach(RELATE)
Brief Summary The primary Objective of this study is to evaluate the safety and tolerability of intraocular injections of 0.5mg or 2.0mg of ranibizumab in patients with macular edema due to retinal vein occlusion.
Detailed Description The secondary objectives are to assess the efficacy of 0.5mg versus 2.0mg of monthly ranibizumab injections in patients with macular edema due to retinal vein occlusion between baseline and month 6. At week 24, patients will be re-randomized to receive pro re nata (prn) ranibizumab+laser photocoagulation versus ranibizumab alone and the efficacy of both treatment options will be compared. Treatment efficacy will be assessed by comparing changes in best corrected visual acuity (BCVA) and central subfiled thickness (CST) between the treatment groups.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Retinal Vein Occlusion
Intervention  ICMJE
  • Drug: Ranibizumab 0.5mg (monthly)
    Branch retinal vein occlusion- Intravitreal injection of 0.5mg ranibizumab alone
  • Drug: Ranibizumab 2.0mg (monthly)
  • Drug: Pro re nata (prn) ranibizumab
  • Procedure: Pro re nata (prn) Laser photocoagulation
Study Arms  ICMJE
  • Experimental: BRVO- Ranibizumab 0.5mg alone
    Branch retinal vein occlusion patients randomized to this group will receive 0.5mg of ranibizumab alone as per protocol without laser photocoagulation.
    Intervention: Drug: Ranibizumab 0.5mg (monthly)
  • Experimental: BRVO- Pro re nata (prn) ranibizumab with laser
    Branch retinal vein occlusion patients randomized to this group will receive 0.5mg/2.0mg of ranibizumab as per protocol, and additional laser photocoagulation if required.
    Interventions:
    • Drug: Pro re nata (prn) ranibizumab
    • Procedure: Pro re nata (prn) Laser photocoagulation
  • Experimental: BRVO- Ranibizumab 2.0mg alone
    Branch retinal vein occlusion patients randomized to this group will receive 2.0mg of ranibizumab alone as per protocol without laser photocoagulation.
    Intervention: Drug: Ranibizumab 2.0mg (monthly)
  • Experimental: BRVO- Pro re nata (prn) ranibizumab
    Branch retinal vein occlusion patients randomized to this group will receive 0.5mg/2.0mg of ranibizumab as per protocol, without additional laser photocoagulation.
    Intervention: Drug: Pro re nata (prn) ranibizumab
  • Experimental: CRVO- Ranibizumab 0.5mg alone
    Central retinal vein occlusion patients randomized to this group will receive 0.5mg of ranibizumab alone as per protocol without laser photocoagulation
    Intervention: Drug: Ranibizumab 0.5mg (monthly)
  • Experimental: CRVO- Pro re nata (prn) ranibizumab with laser
    Central retinal vein occlusion patients randomized to this group will receive 0.5mg/2.0mg of ranibizumab as per protocol, and additional laser photocoagulation if required.
    Interventions:
    • Drug: Pro re nata (prn) ranibizumab
    • Procedure: Pro re nata (prn) Laser photocoagulation
  • Experimental: CRVO- Ranibizumab 2.0mg alone
    Central retinal vein occlusion patients randomized to this group will receive 2.0mg of ranibizumab alone as per protocol without laser photocoagulation.
    Intervention: Drug: Ranibizumab 2.0mg (monthly)
  • Experimental: CRVO- Pro re nata (prn) ranibizumab
    Central retinal vein occlusion patients randomized to this group will receive 0.5mg/2.0mg of ranibizumab as per protocol, without additional laser photocoagulation.
    Intervention: Drug: Pro re nata (prn) 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: April 1, 2015)
81
Original Estimated Enrollment  ICMJE
 (submitted: October 27, 2009)
80
Actual Study Completion Date  ICMJE April 2015
Actual Primary Completion Date April 2015   (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 equal to or greater than 18 years
  • Diagnosis of macular edema due to central or branch retinal vein occlusion
  • Foveal thickness of equal to or greater than 250 mm, as assessed by OCT
  • Best corrected visual acuity score in the study eye of 20/40 to 20/400 inclusive (Snellen equivalents using the ETDRS protocol at a distance of 4 meters). Only one eye will be treated in the study. If both eyes are eligible, the investigator will select the eye to be enrolled.
  • In the opinion of the investigator, decreased vision in the study eye is due to foveal thickening from vein occlusion and not from other obvious causes of decreased vision

Exclusion Criteria:

  • Scatter laser photocoagulation or macular photocoagulation within 3 months of study entry in the study eye
  • Intraocular surgery in the study eye within 3 months of study entry
  • Use of intraocular or periocular injection of steroids in the study eye (e.g., triamcinolone) within 4 months of study entry
  • Previous use of an anti-VEGF drug within 3 months of study entry
  • 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 ³30 mm Hg despite treatment with anti-glaucoma medications)
  • History of cerebral vascular accident, myocardial infarction, transient ischemic attacks within 3 months of study enrollment.
  • Pregnancy (positive pregnancy test) or lactation
  • Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.
  • 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.
  • Any condition that the investigator believes would pose a significant hazard to the subject if investigational therapy were initiated.
  • History of allergy to humanized antibodies or any component of the ranibizumab formulation
  • Inability to comply with study or followup procedures
  • 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 NCT01003106
Other Study ID Numbers  ICMJE NA_00032394
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Peter A Campochiaro, MD, Johns Hopkins University
Study Sponsor  ICMJE Peter A Campochiaro, MD
Collaborators  ICMJE Genentech, Inc.
Investigators  ICMJE
Principal Investigator: Peter A Campochiaro, MD Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date February 2016

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