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

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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

October 26, 2009
October 28, 2009
August 25, 2015
March 15, 2016
March 15, 2016
November 2009
April 2015   (Final data collection date for primary outcome measure)
Incidence and Severity of Ocular and Non-ocular Adverse Events. [ Time Frame: 36 months ]
Incidence and Severity of Ocular and Non-ocular Adverse Events. [ Time Frame: 48 weeks ]
Complete list of historical versions of study NCT01003106 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
Ranibizumab DosE Comparison and the Role of LAser in REtinal Vein Occlusions
RanibizumabDosE Comparison (0.5mg and 2.0mg) and the Role of LAser in the ManagemenT of REtinal Vein Occlusion - A Pharmacodynamic Approach(RELATE)
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.
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.
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Retinal Vein Occlusion
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
81
80
April 2015
April 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01003106
NA_00032394
No
Not Provided
Not Provided
Peter A Campochiaro, MD, Johns Hopkins University
Peter A Campochiaro, MD
Genentech, Inc.
Principal Investigator: Peter A Campochiaro, MD Johns Hopkins University
Johns Hopkins University
February 2016

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